CD ( DrugBank: - )
7 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 6 | Parkinson disease | 65 |
| 13 | Multiple sclerosis/Neuromyelitis optica | 113 |
| 46 | Malignant rheumatoid arthritis | 198 |
| 51 | Scleroderma | 13 |
| 96 | Crohn disease | 431 |
| 97 | Ulcerative colitis | 74 |
| 265 | Lipodystrophy | 1 |
6. Parkinson disease
Clinical trials : 2,298 / Drugs : 2,202 - (DrugBank : 350) / Drug target genes : 188 - Drug target pathways : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2051200104 | 06/01/2021 | 24/12/2020 | A Phase 1 Study of KK6483 in Healthy Male Volunteers | A Phase 1 Study of KK6483 in Healthy Male Volunteers | Parkinson's disease | A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET) | Yagi Michio | NULL | Complete | >= 20age old | < 45age old | Male | 40 | Phase 1 | Japan |
| 2 | NCT04380142 (ClinicalTrials.gov) | October 19, 2020 | 6/5/2020 | Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease | A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients | Parkinson's Disease (PD) | Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951 | AbbVie | NULL | Completed | 30 Years | N/A | All | 174 | Phase 3 | United States;Australia |
| 3 | EUCTR2018-004156-37-PT (EUCTR) | 16/06/2020 | 09/12/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD/CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of | ||
| 4 | EUCTR2018-004156-37-NL (EUCTR) | 14/06/2020 | 13/01/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 5 | EUCTR2018-004156-37-SE (EUCTR) | 18/05/2020 | 10/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 6 | EUCTR2018-004156-37-IT (EUCTR) | 04/05/2020 | 17/06/2021 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson's disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP Product Code: [NA] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Product Name: levodopa/carbidopa solution Product Code: [ND0612] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of | ||
| 7 | EUCTR2018-004156-37-SK (EUCTR) | 30/04/2020 | 13/02/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Levodopa/Carbidopa Solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 8 | EUCTR2018-004156-37-BE (EUCTR) | 27/04/2020 | 03/03/2020 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Serbia;United States;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 9 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 10 | EUCTR2018-004156-37-AT (EUCTR) | 02/03/2020 | 05/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | United States;Portugal;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 11 | EUCTR2018-004156-37-ES (EUCTR) | 11/02/2020 | 06/11/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden | ||
| 12 | EUCTR2018-004156-37-GB (EUCTR) | 14/01/2020 | 13/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden | ||
| 13 | EUCTR2018-004156-37-HU (EUCTR) | 19/12/2019 | 18/10/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden | ||
| 14 | EUCTR2018-004156-37-CZ (EUCTR) | 26/11/2019 | 26/09/2019 | A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless) | A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: levodopa/carbidopa solution Product Code: ND0612 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: IR LD / CD Product Name: Carbidopa and Levodopa tablets, USP INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 482 | Phase 3 | Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden | ||
| 15 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 16 | NCT04006210 (ClinicalTrials.gov) | August 27, 2019 | 30/6/2019 | A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless). | A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless) | Parkinson's Disease | Combination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mg | NeuroDerm Ltd. | NULL | Recruiting | 30 Years | 80 Years | All | 380 | Phase 3 | United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom |
| 17 | EUCTR2018-002233-37-IT (EUCTR) | 03/05/2019 | 07/01/2021 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson's with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. - NA | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: [IPX203] INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: [IR CD-LD] INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 18 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 19 | EUCTR2018-002233-37-CZ (EUCTR) | 18/03/2019 | 11/12/2018 | Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations. | A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. | Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: IPX203 Product Code: IPX203 INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA Trade Name: Carbidopa and Levodopa Tablets, USP Product Name: IR CD-LD (carbidopa-levodopa) tablets Product Code: IR CD-LD INN or Proposed INN: Levodopa INN or Proposed INN: Carbidopa Other descriptive name: ANHYDROUS CARBIDOPA | Impax Laboratories, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy | ||
| 20 | EUCTR2017-005170-19-FI (EUCTR) | 06/03/2019 | 07/12/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Finland;Sweden | ||
| 21 | NCT03887884 (ClinicalTrials.gov) | March 5, 2019 | 1/3/2019 | Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) | Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease | Parkinson's Disease | Drug: CVT-301;Drug: Sinemet | Acorda Therapeutics | NULL | Completed | 30 Years | 85 Years | All | 23 | Phase 1 | United States |
| 22 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations | A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations | Parkinson's Disease (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 631 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 23 | EUCTR2018-000346-19-FI (EUCTR) | 03/10/2018 | 09/07/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 24 | EUCTR2017-005170-19-SE (EUCTR) | 30/07/2018 | 10/04/2018 | A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension Study | A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Renishaw Neuro Solutions Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 1;Phase 2 | Sweden;Finland | ||
| 25 | NCT03775538 (ClinicalTrials.gov) | July 5, 2018 | 11/10/2018 | Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002 | Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 15 | Phase 1/Phase 2 | Finland;Sweden |
| 26 | EUCTR2018-000346-19-SE (EUCTR) | 04/06/2018 | 09/04/2018 | An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease. | A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cerebral Dopamine Neurotrophic Factor Product Code: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Finland;Sweden | ||
| 27 | EUCTR2017-002780-17-ES (EUCTR) | 21/05/2018 | 12/02/2018 | Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa. | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | France;United States;Spain;Austria;Netherlands;Italy | ||
| 28 | EUCTR2017-002780-17-FR (EUCTR) | 26/04/2018 | 27/02/2018 | - | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension | Parkinson’s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa Other descriptive name: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: levodopa Other descriptive name: LEVODOPA INN or Proposed INN: carbidopa | NeuroDerm Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Austria;Netherlands;Italy | ||
| 29 | EUCTR2017-002780-17-IT (EUCTR) | 10/04/2018 | 04/11/2020 | study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusion | A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered | Parkinson¿s Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET Plus Product Name: SINEMET INN or Proposed INN: LEVODOPA INN or Proposed INN: CARBIDOPA Trade Name: Duodopa LD/CD 20/5 mg/mL Product Name: Duodopa LD/CD 20/5 mg/mL INN or Proposed INN: LEVODOPA Other descriptive name: levodopa INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa Product Name: ND0612 Product Code: ND0612 INN or Proposed INN: CARBIDOPA Other descriptive name: carbidopa INN or Proposed INN: LEVODOPA Other descriptive name: levodopa | NEURODERM LTD. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United States;France;Spain;Austria;Netherlands;Italy | ||
| 30 | EUCTR2015-004175-73-FI (EUCTR) | 27/09/2017 | 07/07/2016 | A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease. | A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. | Idiopathic Parkinson's Disease MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: CDNF INN or Proposed INN: Not Applicable Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor | Herantis Pharma Plc | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 1;Phase 2 | Finland | ||
| 31 | NCT03295786 (ClinicalTrials.gov) | September 26, 2017 | 14/9/2017 | Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease | Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease | Parkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain Diseases | Drug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery System | Herantis Pharma Plc. | Renishaw plc. | Completed | 35 Years | 75 Years | All | 17 | Phase 1/Phase 2 | Finland;Sweden |
| 32 | EUCTR2015-003513-24-SK (EUCTR) | 14/03/2017 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 33 | NCT03007888 (ClinicalTrials.gov) | November 14, 2016 | 6/12/2016 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease | Advanced Parkinson's Disease | Drug: IR CD-LD;Drug: ER CD-LD | Impax Laboratories, LLC | NULL | Completed | 40 Years | 100 Years | All | 28 | Phase 2 | United States |
| 34 | EUCTR2015-003513-24-DE (EUCTR) | 08/09/2016 | 15/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 35 | NCT02615873 (ClinicalTrials.gov) | July 2016 | 23/11/2015 | A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004 | An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | 100 Years | All | 460 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom |
| 36 | EUCTR2015-003513-24-BG (EUCTR) | 27/06/2016 | 26/04/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 37 | EUCTR2015-003513-24-IT (EUCTR) | 23/06/2016 | 05/11/2020 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [NA] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 266 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 38 | EUCTR2015-005814-31-IT (EUCTR) | 23/06/2016 | 14/01/2021 | Not available | A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND | advanced Parkinson's disease MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Soluzione di levodopa/carbidopa Product Code: ND0612 INN or Proposed INN: LEVODOPA Other descriptive name: LEVODOPA (LD) INN or Proposed INN: CARBIDOPA Other descriptive name: CARBIDOPA (CD) | NEURODERM LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy | ||
| 39 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 40 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg Product Code: [na] INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | INTEC PHARMA LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 41 | EUCTR2015-003513-24-HU (EUCTR) | 24/05/2016 | 02/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 42 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 43 | EUCTR2015-003513-24-ES (EUCTR) | 18/05/2016 | 18/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | Parkinson's Disease MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 44 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA | Intec Pharma, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 45 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 46 | EUCTR2015-003513-24-GB (EUCTR) | 28/04/2016 | 04/03/2016 | OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 | MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 266 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 47 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients | Parkinson's Disease MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: SINEMET 25-100 Product Name: Immediate Release carbidopa/levodopa 25/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Trade Name: SINEMET 10-100 Product Name: Immediate Release carbidopa/levodopa 10/100 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg INN or Proposed INN: Carbidopa Other descriptive name: CARBIDOPA INN or Proposed INN: Levodopa Other descriptive name: LEVODOPA | Intec Pharma, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 48 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 49 | NCT02271503 (ClinicalTrials.gov) | November 2015 | 13/10/2014 | A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease | A Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's Disease | Parkinson's Disease | Drug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mg | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 26 | Phase 2 | United States |
| 50 | NCT02604914 (ClinicalTrials.gov) | May 2015 | 3/11/2015 | A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects | 1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal Gel | Parkinson's Disease | Drug: ND0612;Drug: LCIG | NeuroDerm Ltd. | Quotient Clinical | Completed | 30 Years | 65 Years | All | 36 | Phase 1 | United Kingdom |
| 51 | NCT02763137 (ClinicalTrials.gov) | January 2015 | 26/4/2016 | Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients | A Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor Fluctuations | Parkinson Disease | Drug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CD | IRCCS San Raffaele | SynAgile Corporation | Completed | 35 Years | 75 Years | Both | 18 | Phase 2 | Italy |
| 52 | JPRN-JapicCTI-142702 | 01/11/2014 | 12/11/2014 | A Phase 1 Study of ONO-2160/CD | A Phase 1 study on single and multiple oral dose administration of ONO-2160/CD in healthy adult male subjects and on multiple oral dose administration of ONO-2160/CD in Parkinson's disease patients | Parkinson's disease | Intervention name : ONO-2160/CD Dosage And administration of the intervention : Oral administration Control intervention name : Levodopa/carbidopa hydrate INN of the control intervention : Levodopa/carbidopa hydrate Dosage And administration of the control intervention : Oral administration | ONO PHARMACEUTICAL CO.,LTD. | NULL | BOTH | 34 | Phase 1 | NULL | |||
| 53 | NCT02096601 (ClinicalTrials.gov) | August 2014 | 18/3/2014 | A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients | A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD | Parkinson's Disease | Drug: Levodopa and carbidopa SC solution;Drug: Oral levodopa and carbidopa | NeuroDerm Ltd. | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | 80 Years | All | 16 | Phase 1/Phase 2 | United States;Israel |
| 54 | JPRN-JapicCTI-132189 | 01/6/2013 | 12/07/2013 | A Phase 1 Study of ONO-2160/CD | A Phase 1 study on single oral dose administration of ONO-2160/CD in healthy adult male subjects and Parkinson's disease patients | Parkinson's disease | Intervention name : ONO-2160/CD Dosage And administration of the intervention : Oral administration Control intervention name : Levodopa/carbidopa hydrate INN of the control intervention : Levodopa/Carbidopa Hydrate Dosage And administration of the control intervention : Oral administration | ONO PHARMACEUTICAL CO.,LTD. | NULL | BOTH | 42 | Phase 1 | NULL | |||
| 55 | NCT00947037 (ClinicalTrials.gov) | August 2012 | 24/7/2009 | Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study | An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects | Parkinson's Disease | Drug: AP-CD/LD | Intec Pharma Ltd. | NULL | Withdrawn | 30 Years | 95 Years | Both | 0 | Phase 2 | Israel |
| 56 | NCT01411137 (ClinicalTrials.gov) | August 2011 | 4/8/2011 | Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study | An Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PD | Parkinson's Disease | Drug: IPX066 | Impax Laboratories, LLC | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 43 | Phase 3 | United States |
| 57 | EUCTR2009-014688-37-PL (EUCTR) | 09/02/2010 | 20/01/2010 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 58 | EUCTR2009-017416-33-DE (EUCTR) | 18/01/2010 | 21/12/2009 | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. | Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE Trade Name: Tasmar Product Name: Tolcapon Product Code: TO INN or Proposed INN: TOLCAPONE Trade Name: Comtess Product Name: Entacapon Product Code: EN INN or Proposed INN: ENTACAPONE Trade Name: Isicom Product Name: Levodopa/Carbidopa Product Code: LD/CD INN or Proposed INN: LEVODOPA Other descriptive name: CARBIDOPA MONOHYDRATE | Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 59 | EUCTR2009-014688-37-ES (EUCTR) | 30/12/2009 | 21/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. | Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: Sinemet-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 60 | EUCTR2009-014688-37-DE (EUCTR) | 15/12/2009 | 07/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-245 INN or Proposed INN: CARBIDOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;France;Spain;Poland | |||
| 61 | EUCTR2009-014688-37-FR (EUCTR) | 04/12/2009 | 09/10/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease | Advanced Parkinson’s Disease subjects with motor fluctuations MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease | Product Name: IPX066 Product Code: IPX066-95 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Trade Name: SINEMET®-Plus Tablets Product Name: IR CD-LD INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-145 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA Product Name: IPX066 Product Code: IPX066-195 INN or Proposed INN: CARBIDOPA INN or Proposed INN: LEVODOPA | Impax Laboratories, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | France;Poland;Spain;Germany | ||
| 62 | NCT00974974 (ClinicalTrials.gov) | September 2009 | 10/9/2009 | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD). | A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 471 | Phase 3 | United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine |
| 63 | NCT00869791 (ClinicalTrials.gov) | November 2008 | 24/3/2009 | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa | Parkinson's Disease | Drug: IPX066;Drug: IR CD-LD | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 27 | Phase 2 | United States |
| 64 | NCT00279825 (ClinicalTrials.gov) | January 2006 | 18/1/2006 | Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease | Idiopathic Parkinson's Disease | Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 16 | Phase 2 | United States |
| 65 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05029609 (ClinicalTrials.gov) | October 2021 | 27/8/2021 | Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS | A Phase 1b, Double-Blind, Randomized, Placebo Controlled, Multiple Ascending Dose Study of the Safety, Tolerability and Immune Effects of the Intranasal Anti-CD3 Monoclonal Antibody Foralumab in Primary and Secondary Progressive MS | Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Multiple Sclerosis | Drug: Intranasal Foralumab Solution;Drug: Placebo | Tiziana Life Sciences, PLC | NULL | Not yet recruiting | 25 Years | 70 Years | All | 55 | Phase 1 | NULL |
| 2 | NCT04798651 (ClinicalTrials.gov) | September 30, 2021 | 11/3/2021 | Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis | Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis | Multiple Sclerosis;Clinically Isolated Syndrome | Biological: blood sample;Biological: cerebro-spinal fluid | University Hospital, Bordeaux | University of Bordeaux | Recruiting | 18 Years | N/A | All | 150 | N/A | France |
| 3 | EUCTR2020-004785-19-DE (EUCTR) | 07/07/2021 | 17/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;France;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 4 | NCT04879628 (ClinicalTrials.gov) | June 7, 2021 | 6/5/2021 | Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: SAR441344 IV;Drug: placebo IV;Drug: SAR441344 SC;Drug: placebo SC;Drug: MRI contrast-enhancing preparations | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 120 | Phase 2 | United States;Bulgaria;Canada;Czechia;France;Germany;Spain;Turkey;Ukraine |
| 5 | EUCTR2020-004785-19-CZ (EUCTR) | 01/06/2021 | 05/02/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Bulgaria;Russian Federation;Germany | ||
| 6 | EUCTR2020-004785-19-BG (EUCTR) | 28/04/2021 | 09/03/2021 | Proof-of-concept study for SAR441344 in relapsing multiple sclerosis | A Phase 2, double-blind, randomized, placebo-controlled study assessing efficacy and safety of SAR441344, a CD40L-antagonist monoclonal antibody, in participants with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: Not Applicable Other descriptive name: SAR441344 | Sanofi-Aventis Recherche et Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;United States;Czechia;Czech Republic;Canada;Spain;Turkey;Russian Federation;Bulgaria;Germany | ||
| 7 | NCT04640818 (ClinicalTrials.gov) | December 17, 2020 | 18/11/2020 | Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy | Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study | Multiple Sclerosis | Drug: Cladribine Oral Tablet;Drug: Rituximab;Drug: Ocrelizumab | Claudio Gobbi | Merck AG Switzerland | Recruiting | 18 Years | 80 Years | All | 45 | Switzerland | |
| 8 | NCT04486716 (ClinicalTrials.gov) | October 19, 2020 | 23/7/2020 | A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis | A Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS) | Relapsing Multiple Sclerosis | Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 60 Years | All | 100 | Phase 3 | United States;Puerto Rico |
| 9 | JPRN-jRCT2051210017 | 15/10/2020 | 07/05/2021 | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | An extension study for seven patients in Japan with neuromyelitis optica spectrum disorder who completed the open-label period of study CD-IA-MEDI-551-1155 of Inebilizumab | Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders | This study is designed to provide the opportunity of continued access to inebilizumab to patients with NMOSD who received inebilizumab in the completed Study CD-IA-MEDI-551-1155. The fixed dose of 300 mg inebilizumab every 26 weeks is injected to maintain peripheral B-cell suppression in subjects. | Sato Toshiyuki | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 7 | Phase 3 | Japan |
| 10 | ChiCTR1900025744 | 2019-09-01 | 2019-09-07 | Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | neuromyelitis optica spectrum disorder (NMOSD) | 1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day); | The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital | NULL | Recruiting | 18 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 11 | NCT03605238 (ClinicalTrials.gov) | August 15, 2018 | 29/6/2018 | Treatment of Relapsed and/or Refractory AQP4-IgG Seropositive NMOSD by Tandem CAR T Cells Targeting CD19 and CD20 | Clinical Study of CD19/CD20 tanCAR T Cells in Relapsed and/or Refractory AQP4-IgG Seropositive Neuromyelitis Optica Spectrum Disorders (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Biological: Corticosteroids & tanCART19/20 | Chinese PLA General Hospital | NULL | Withdrawn | 12 Years | 75 Years | All | 0 | Phase 1 | China |
| 12 | EUCTR2017-002632-17-GB (EUCTR) | 25/07/2018 | 06/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Sweden;United Kingdom | ||
| 13 | EUCTR2017-002632-17-PT (EUCTR) | 16/07/2018 | 19/04/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 14 | EUCTR2017-002631-42-IT (EUCTR) | 16/07/2018 | 17/06/2021 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis - . | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Mavenclad Product Code: [-] INN or Proposed INN: CLADRIBINA Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | MERCK KGAA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 4 | Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 15 | EUCTR2017-002632-17-AT (EUCTR) | 11/07/2018 | 05/01/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 16 | EUCTR2017-002631-42-FI (EUCTR) | 26/06/2018 | 28/02/2018 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 17 | EUCTR2017-002632-17-SK (EUCTR) | 26/06/2018 | 17/04/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Czechia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 18 | EUCTR2017-002632-17-GR (EUCTR) | 05/06/2018 | 29/05/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 19 | EUCTR2017-002632-17-BE (EUCTR) | 24/05/2018 | 01/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 20 | EUCTR2017-002631-42-GB (EUCTR) | 21/05/2018 | 18/12/2017 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 21 | EUCTR2017-002632-17-NL (EUCTR) | 14/05/2018 | 27/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 22 | EUCTR2017-002631-42-BE (EUCTR) | 09/05/2018 | 22/02/2018 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 23 | EUCTR2017-002631-42-CZ (EUCTR) | 25/04/2018 | 30/01/2018 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 265 | Phase 4 | Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 24 | EUCTR2017-002632-17-CZ (EUCTR) | 25/04/2018 | 29/01/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Czechia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 25 | EUCTR2017-002631-42-SE (EUCTR) | 18/04/2018 | 05/12/2017 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 265 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 26 | EUCTR2017-002632-17-SE (EUCTR) | 18/04/2018 | 17/01/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 27 | EUCTR2017-000426-35-AT (EUCTR) | 17/04/2018 | 12/03/2018 | The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trial | Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS | Relapse Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB | Medical University of Vienna - Department of Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 2 | Austria | ||
| 28 | EUCTR2017-002632-17-FR (EUCTR) | 10/04/2018 | 07/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 29 | EUCTR2017-002631-42-FR (EUCTR) | 10/04/2018 | 14/02/2018 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 30 | EUCTR2017-002632-17-DK (EUCTR) | 21/03/2018 | 01/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Australia;Netherlands;Norway;Sweden | ||
| 31 | EUCTR2017-002632-17-ES (EUCTR) | 16/03/2018 | 25/01/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 32 | EUCTR2017-002632-17-FI (EUCTR) | 05/03/2018 | 05/02/2018 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 33 | EUCTR2017-002631-42-HU (EUCTR) | 26/02/2018 | 28/12/2017 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 34 | EUCTR2017-002632-17-HU (EUCTR) | 26/02/2018 | 28/12/2017 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden | ||
| 35 | EUCTR2017-002631-42-AT (EUCTR) | 19/02/2018 | 11/01/2018 | A Clinical Research Study for People with Relapsing Multiple Sclerosis | A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 265 | Phase 4 | United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden;Israel;Austria;Ireland;Spain;Finland;Czechia | ||
| 36 | EUCTR2017-002632-17-LT (EUCTR) | 30/01/2018 | 21/12/2017 | A Quality of Life Study for People with Relapsing Multiple Sclerosis | A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® | Relapsing multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Mavenclad® Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA) | Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 4 | Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden | ||
| 37 | NCT04082260 (ClinicalTrials.gov) | January 2017 | 28/8/2019 | Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response | Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response | Multiple Sclerosis | Drug: Alemtuzumab Injection [Lemtrada] | University Hospital Muenster | NULL | Recruiting | 18 Years | N/A | All | 150 | Germany | |
| 38 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 39 | NCT02738775 (ClinicalTrials.gov) | March 18, 2016 | 10/4/2016 | Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple Sclerosis | A Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis. | Multiple Sclerosis | Biological: Ublituximab;Drug: Placebo | TG Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 2 | United States |
| 40 | NCT02427776 (ClinicalTrials.gov) | January 2015 | 2/4/2015 | A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis | A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL) | Multiple Sclerosis, Relapsing-Remitting | Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope | Imcyse SA | NULL | Terminated | 18 Years | 50 Years | All | 2 | Phase 1/Phase 2 | Belgium |
| 41 | EUCTR2014-001081-99-BE (EUCTR) | 16/12/2014 | 03/12/2014 | A first in human trial for evaluating both safety and preliminary efficacy of a single infusion of stimulated autologous CD4+ cells in patients with Relapsing- Remitting multiple sclerosis | A clinical trial to document safety and radiological disease activity in patients with relapsing-remitting multiple sclerosis treated with autologous CD4+ cells, stimulated and expanded ex vivo by a myelin oligodendrocyte glycoprotein (MOG) peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope (SCLEROLYM trial).First-in-human trial - SCLEROLYM Trial | Multiple sclerosis is an immune-mediated inflammatory disease that attacks myelinated axons in the central nervous system. MS is characterized initially by episodes of reversible neurologic deficits. In most patients, these episodes are followed by progressive neurologic deterioration over time. Relapsing-remitting multiple sclerosis is characterized by recurrent attacks of neurologic dysfunction (relapses) followed by periods of complete or incomplete recovery (remission) MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SCLEROLYM INN or Proposed INN: Cytolytic CD4+ T cells Other descriptive name: AUTOLOGOUS T-LYMPHOCYTES | ImCyse S.A | NULL | Not Recruiting | Female: yes Male: yes | Phase 1;Phase 2 | Belgium | |||
| 42 | NCT02142764 (ClinicalTrials.gov) | November 2014 | 15/5/2014 | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients | Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS). | Multiple Sclerosis | Biological: Blood samples | University Hospital, Bordeaux | Merck Serono International SA;ADERA | Completed | 18 Years | N/A | Both | 30 | N/A | France |
| 43 | EUCTR2009-017978-21-PL (EUCTR) | 17/08/2012 | 06/03/2012 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 44 | EUCTR2009-017978-21-PT (EUCTR) | 06/07/2012 | 11/08/2011 | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 45 | EUCTR2011-005606-30-GB (EUCTR) | 25/04/2012 | 02/04/2012 | Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H). | Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY | This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab. MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Kepivance Product Name: Kepivance INN or Proposed INN: Palifermin Trade Name: MabCampath Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: anti-CD52 monoclonal antibody | Cambridge University Hospitals NHS Foundation Trust and University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 46 | EUCTR2009-017978-21-GR (EUCTR) | 17/01/2012 | 08/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 47 | EUCTR2009-017978-21-DK (EUCTR) | 21/09/2011 | 12/09/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 48 | EUCTR2009-017978-21-LT (EUCTR) | 25/07/2011 | 30/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 49 | EUCTR2009-017978-21-ES (EUCTR) | 13/07/2011 | 17/11/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry | Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina. MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 50 | EUCTR2009-017978-21-BE (EUCTR) | 12/07/2011 | 29/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 51 | EUCTR2009-017978-21-SE (EUCTR) | 08/06/2011 | 03/05/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 52 | EUCTR2009-017978-21-FI (EUCTR) | 07/06/2011 | 28/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 53 | EUCTR2009-017978-21-CZ (EUCTR) | 06/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2175 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | |||
| 54 | EUCTR2009-017978-21-GB (EUCTR) | 03/06/2011 | 11/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden | ||
| 55 | EUCTR2009-017978-21-IT (EUCTR) | 16/05/2011 | 05/01/2012 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine Tablet INN or Proposed INN: CLADRIBINE Other descriptive name: 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine | MERCK SERONO SA | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Phase 3 | Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 56 | EUCTR2009-017978-21-LV (EUCTR) | 06/05/2011 | 18/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 15.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 57 | EUCTR2009-017978-21-AT (EUCTR) | 05/05/2011 | 31/03/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 58 | EUCTR2009-017978-21-EE (EUCTR) | 21/04/2011 | 13/04/2011 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 59 | NCT01407211 (ClinicalTrials.gov) | April 2011 | 14/2/2011 | Impact of Vitamin A on Gene Expression, in Multiple Sclerosis Patient | The Impact of Vitamin A Supplementation on Gene Expression of Cytokine Secreted by CD4+ T Lymphocyte in Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Dietary Supplement: vitamin A | Tehran University of Medical Sciences | NULL | Enrolling by invitation | 20 Years | 45 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 60 | EUCTR2009-017978-21-BG (EUCTR) | 08/02/2011 | 11/09/2015 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 18.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 61 | NCT01466322 (ClinicalTrials.gov) | December 22, 2010 | 3/11/2011 | A Study to Assess the Relative Bioavailability of Different Formulations of GSK2018682, a Sphingosine-1-phosphate Receptor Subtype 1 Agonist, in Healthy Volunteers. | An Open-label, Randomised, Crossover Study to Assess the Relative Bioavailability of Different 2mg Formulations of GSK2018682(S1P1 Agonist) in Healthy Volunteers | Multiple Sclerosis, Relapsing-Remitting | Drug: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | Australia |
| 62 | EUCTR2009-017978-21-DE (EUCTR) | 20/12/2010 | 22/11/2010 | Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials | Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry | Multiple Sclerosis patients who have participated in cladribine tablets clinical trials MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine tablets Product Code: Not applicable INN or Proposed INN: Cladribine Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 2175 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden | ||
| 63 | EUCTR2008-008554-23-SE (EUCTR) | 29/12/2009 | 26/06/2009 | Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF | Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF | IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation). MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif Product Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | The Multiple Sclerosis Research Group, Department of Clinical Neuroscience | NULL | Not Recruiting | Female: yes Male: yes | 100 | Sweden | |||
| 64 | EUCTR2008-003706-33-GB (EUCTR) | 09/06/2009 | 27/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 65 | EUCTR2008-003706-33-SE (EUCTR) | 04/06/2009 | 09/04/2009 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;United Arab Emirates;Serbia;Portugal;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 66 | EUCTR2008-003706-33-BG (EUCTR) | 28/05/2009 | 09/07/2009 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway | ||
| 67 | EUCTR2008-003706-33-DE (EUCTR) | 31/03/2009 | 09/12/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain | ||
| 68 | EUCTR2008-003706-33-CZ (EUCTR) | 24/03/2009 | 22/10/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 69 | EUCTR2008-003706-33-BE (EUCTR) | 16/03/2009 | 09/12/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine Product Code: L01BB04 INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden | ||
| 70 | EUCTR2008-003706-33-PT (EUCTR) | 06/03/2009 | 17/12/2008 | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono SA - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden | ||
| 71 | EUCTR2007-004223-38-GB (EUCTR) | 05/01/2009 | 26/11/2007 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline UK | NULL | Not Recruiting | Female: yes Male: yes | 57 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 72 | EUCTR2008-003706-33-EE (EUCTR) | 31/12/2008 | 20/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Romania;Estonia;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 73 | EUCTR2008-003706-33-FI (EUCTR) | 18/12/2008 | 10/11/2008 | Clinical trial with oral cladribine in early Multiple Sclerosis (MS) | A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial | Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta-1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA-1A | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon | ||
| 74 | EUCTR2007-000381-20-BG (EUCTR) | 28/10/2008 | 20/10/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 75 | EUCTR2007-000381-20-GR (EUCTR) | 09/09/2008 | 01/04/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom | |||
| 76 | EUCTR2007-000381-20-NL (EUCTR) | 29/08/2008 | 01/02/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 77 | EUCTR2007-000381-20-LT (EUCTR) | 15/07/2008 | 06/06/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 78 | NCT00726648 (ClinicalTrials.gov) | July 2008 | 29/7/2008 | CDP323 Biomarker Study | Double-blind, Placebo-controlled, Randomized, Parallel-group Study in Subjects With Relapsing Forms of Multiple Sclerosis to Evaluate the Effects of Different CDP323 Doses on Biomarker Patterns as Well as on Safety and Tolerability. | Relapsing Multiple Sclerosis | Drug: CDP323;Drug: Placebo | UCB Pharma | Biogen Idec | Completed | 18 Years | 65 Years | Both | 71 | Phase 1/Phase 2 | United Kingdom |
| 79 | EUCTR2007-004223-38-DE (EUCTR) | 02/06/2008 | 24/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Phase 2 | Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 80 | EUCTR2007-000381-20-LV (EUCTR) | 29/05/2008 | 12/05/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 81 | EUCTR2007-000381-20-EE (EUCTR) | 19/05/2008 | 28/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 82 | EUCTR2007-004223-38-SE (EUCTR) | 05/05/2008 | 13/03/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline AB | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;Czech Republic;United Kingdom;Denmark;Sweden | |||
| 83 | EUCTR2007-000381-20-PT (EUCTR) | 28/04/2008 | 15/01/2008 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece | |||
| 84 | EUCTR2007-000381-20-CZ (EUCTR) | 23/04/2008 | 14/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 85 | EUCTR2007-004223-38-BE (EUCTR) | 16/04/2008 | 06/05/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 324 | Sweden;Czech Republic;Belgium;Denmark;Germany;United Kingdom | |||
| 86 | EUCTR2007-000381-20-DK (EUCTR) | 15/04/2008 | 05/03/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 87 | EUCTR2007-004223-38-DK (EUCTR) | 04/04/2008 | 23/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 57 | Czech Republic;Denmark;Germany;United Kingdom;Sweden | |||
| 88 | EUCTR2007-000381-20-DE (EUCTR) | 17/03/2008 | 28/02/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany | ||
| 89 | EUCTR2007-000381-20-GB (EUCTR) | 04/03/2008 | 26/11/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 90 | EUCTR2007-004223-38-CZ (EUCTR) | 27/02/2008 | 02/01/2008 | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline s.r.o. | NULL | Not Recruiting | Female: yes Male: yes | 57 | Germany;United Kingdom;Czech Republic;Denmark;Sweden | |||
| 91 | EUCTR2007-000381-20-BE (EUCTR) | 21/01/2008 | 20/12/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany | ||
| 92 | EUCTR2007-000381-20-AT (EUCTR) | 30/12/2007 | 03/01/2008 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 93 | EUCTR2007-000381-20-FR (EUCTR) | 14/12/2007 | 17/10/2007 | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany | ||
| 94 | EUCTR2007-000381-20-FI (EUCTR) | 16/11/2007 | 15/10/2007 | CLARITY Extension Study | A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION | Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: cladribine Product Code: Not Applicable INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA) | Merck Serono S.A. - Geneva | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon | ||
| 95 | EUCTR2006-002204-33-HU (EUCTR) | 29/10/2007 | 22/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Finland;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 96 | EUCTR2006-002204-33-DE (EUCTR) | 29/08/2007 | 12/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 97 | EUCTR2006-002204-33-FR (EUCTR) | 18/07/2007 | 26/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 98 | EUCTR2006-002204-33-GB (EUCTR) | 18/06/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 99 | EUCTR2006-002204-33-ES (EUCTR) | 04/05/2007 | 05/03/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas. | Relapsing forms of multiple slerosisEsclerosis multiple (EM) con recaidas MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 279 | Phase 2 | France;Hungary;Finland;Belgium;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 100 | NCT00484536 (ClinicalTrials.gov) | May 2007 | 8/6/2007 | Placebo Controlled Study in Subjects With Relapsing Forms of MS to Evaluate the Safety, Tolerability and Effects of CDP323 | Double-blind, Placebo-controlled, Randomized, Parallel-group Phase II Study in Subjects With Relapsing Forms of Multiple Sclerosis (MS) to Evaluate the Safety, Tolerability, and Effects of CDP323. | Multiple Sclerosis | Drug: CDP323;Drug: placebo | UCB Pharma | Biogen Idec | Terminated | 18 Years | 55 Years | Both | 232 | Phase 2 | United States;Belgium;Canada;Finland;France;Germany;Hungary;Netherlands;Spain;Sweden;United Kingdom |
| 101 | EUCTR2006-002204-33-SE (EUCTR) | 20/04/2007 | 26/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 102 | EUCTR2006-002204-33-NL (EUCTR) | 16/04/2007 | 31/10/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 103 | EUCTR2006-002204-33-FI (EUCTR) | 05/04/2007 | 20/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | Hungary;Finland;United Kingdom;Germany;Netherlands;France;Spain;Sweden | ||
| 104 | EUCTR2006-002204-33-BE (EUCTR) | 02/03/2007 | 08/02/2007 | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks. | Relapsing forms of multiple slerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: CDP323 Product Code: CDP323 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 317 | Phase 2 | France;Hungary;Finland;Spain;Belgium;Netherlands;Germany;United Kingdom;Sweden | ||
| 105 | NCT00288626 (ClinicalTrials.gov) | July 2006 | 7/2/2006 | High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study | A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 60 Years | All | 25 | Phase 2 | United States |
| 106 | EUCTR2005-001567-55-DE (EUCTR) | 23/06/2006 | 29/07/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United Kingdom;Germany;Spain | ||
| 107 | EUCTR2005-001567-55-GB (EUCTR) | 14/12/2005 | 24/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 108 | EUCTR2005-001567-55-ES (EUCTR) | 18/10/2005 | 05/09/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United Kingdom;Germany;Spain | ||
| 109 | EUCTR2005-001567-55-AT (EUCTR) | 27/09/2005 | 23/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 110 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| 111 | NCT00666224 (ClinicalTrials.gov) | January 2004 | 22/4/2008 | Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to Clinically Definite Multiple Sclerosis of Subjects Presenting With Clinically Isolated Syndrome | A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to Clinically Definite Multiple Sclerosis (CDMS) of Subjects Presenting With Clinically Isolated Syndrome (CIS) | Multiple Sclerosis | Drug: Glatiramer Acetate (DB);Drug: Placebo;Drug: Glatiramer Acetate (OL) | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 45 Years | All | 481 | Phase 3 | Argentina;Australia;Austria;Denmark;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Romania;Spain;Sweden;United Kingdom;United States |
| 112 | NCT00040482 (ClinicalTrials.gov) | April 1999 | 26/6/2002 | High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis | Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Cyclophosphamide;Drug: ATG;Drug: MESNA;Procedure: Radiation therapy | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 60 Years | All | 10 | Phase 2 | United States |
| 113 | NCT00004816 (ClinicalTrials.gov) | July 1995 | 24/2/2000 | A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: monoclonal antibody M-T412 | National Center for Research Resources (NCRR) | Stanford University | Completed | 21 Years | 75 Years | Both | 25 | Phase 1 | NULL |
46. Malignant rheumatoid arthritis
Clinical trials : 4,325 / Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04078191 (ClinicalTrials.gov) | September 14, 2021 | 21/8/2019 | Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA) | A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Drug: Tc 99m tilmanocept | Navidea Biopharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States;United Kingdom |
| 2 | JPRN-jRCTs041200048 | 02/10/2020 | 02/10/2020 | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study | Rheumatoid arthritis | 1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Recruiting | >= 20age old | Not applicable | Both | 114 | N/A | Japan |
| 3 | ChiCTR2000033214 | 2020-06-01 | 2020-05-24 | Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis | Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis | Rheumatoid Arthritis | Group 1:Tofacitinib;Group 2:cDMARDs; | Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University | NULL | Pending | 18 | Both | Group 1:52;Group 2:52; | Phase 4 | NULL | |
| 4 | EUCTR2018-003418-41-GB (EUCTR) | 18/05/2020 | 22/11/2019 | A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint. | A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA) | Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Lymphoseek Product Name: technetium Tc 99m tilmanocept INN or Proposed INN: not applicable Other descriptive name: TILMANOCEPT | Navidea Biopharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;European Union;United Kingdom | ||
| 5 | JPRN-jRCT1041190125 | 09/03/2020 | 09/03/2020 | PRECIOUS-B study | Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study | Rheumatoid arthritis | 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Takahashi Nobunori | NULL | Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 6 | EUCTR2016-002344-16-GB (EUCTR) | 28/06/2018 | 29/11/2017 | Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency. | Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Benepali Product Name: Benepali INN or Proposed INN: ETANERCEPT | University of Leeds | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 7 | NCT03522415 (ClinicalTrials.gov) | May 28, 2018 | 29/4/2018 | Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate | Moderately to Severely Active Rheumatoid Arthritis | Drug: HLX01;Drug: Methotrexate(MTX) | Shanghai Henlius Biotech | NULL | Completed | 18 Years | 75 Years | All | 275 | Phase 3 | China |
| 8 | EUCTR2015-005309-35-LV (EUCTR) | 04/08/2017 | 19/05/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 9 | EUCTR2015-005309-35-BG (EUCTR) | 22/06/2017 | 02/05/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International, LLC. | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico | ||
| 10 | EUCTR2015-005309-35-GB (EUCTR) | 16/06/2017 | 09/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 11 | EUCTR2015-005309-35-DE (EUCTR) | 23/05/2017 | 24/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of;Belarus;United States;Czechia;Taiwan;Estonia;Lithuania;Russian Federation;Colombia | ||
| 12 | EUCTR2015-005309-35-PL (EUCTR) | 19/05/2017 | 17/03/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Belarus;United States;Czechia;Estonia;Taiwan;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Georgia;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 13 | EUCTR2015-005309-35-CZ (EUCTR) | 16/03/2017 | 31/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 14 | EUCTR2015-005309-35-HU (EUCTR) | 16/03/2017 | 02/02/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 15 | NCT03110094 (ClinicalTrials.gov) | March 13, 2017 | 10/3/2017 | Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis | Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations | Rheumatoid Arthritis | Other: Adalimumab;Other: Healthy volunteers | Rennes University Hospital | NULL | Unknown status | 18 Years | N/A | All | 60 | N/A | France |
| 16 | EUCTR2015-005309-35-LT (EUCTR) | 06/03/2017 | 31/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Turkey;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of | ||
| 17 | EUCTR2015-005307-83-LV (EUCTR) | 03/03/2017 | 16/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 18 | EUCTR2015-005307-83-DE (EUCTR) | 10/11/2016 | 24/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 19 | EUCTR2015-005308-27-DE (EUCTR) | 08/11/2016 | 09/05/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of | ||
| 20 | JPRN-jRCTs041180071 | 13/10/2016 | 07/03/2019 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study | Rheumatoid arthritis | At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Complete | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 21 | NCT02648035 (ClinicalTrials.gov) | September 22, 2016 | 5/1/2016 | EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis | Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study. | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 200 | Greece | |
| 22 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 23 | EUCTR2015-005307-83-BG (EUCTR) | 04/08/2016 | 17/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 24 | JPRN-UMIN000021247 | 2016/07/22 | 22/07/2016 | Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state | Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study) | Rheumatoid arthritis | Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained. | Nagoya University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 51 | Not selected | Japan |
| 25 | EUCTR2015-005307-83-PL (EUCTR) | 06/07/2016 | 01/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira) Product Code: LO4AB04 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 26 | EUCTR2015-005307-83-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 27 | EUCTR2015-005308-27-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of | ||
| 28 | EUCTR2015-005307-83-CZ (EUCTR) | 07/06/2016 | 18/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm International LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Korea, Republic of;Germany;Latvia;Georgia;Bulgaria;Romania;Brazil;Poland;Argentina;Mexico;Hungary;Czech Republic;United Kingdom;Colombia;Russian Federation;Lithuania;Estonia;Taiwan;United States | ||
| 29 | EUCTR2015-005308-27-CZ (EUCTR) | 07/06/2016 | 15/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of | ||
| 30 | EUCTR2014-004719-36-BG (EUCTR) | 14/05/2016 | 05/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Belarus;Turkey;Russian Federation;Bulgaria | ||
| 31 | EUCTR2015-005307-83-LT (EUCTR) | 04/05/2016 | 25/03/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of | ||
| 32 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 33 | NCT02451748 (ClinicalTrials.gov) | August 2015 | 6/5/2015 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA | Rheumatoid Arthritis | Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira | University of Illinois at Chicago | UCB Pharma | Completed | 18 Years | N/A | All | 32 | Phase 4 | United States |
| 34 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 35 | EUCTR2011-002067-20-FR (EUCTR) | 13/01/2015 | 23/08/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 36 | NCT02296775 (ClinicalTrials.gov) | November 2014 | 18/11/2014 | Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: DRL_RI;Biological: Rituxan;Biological: MabThera | Dr. Reddy's Laboratories Limited | NULL | Completed | 18 Years | 65 Years | All | 276 | Phase 1/Phase 2 | India;Ukraine | |
| 37 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 38 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 39 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 40 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 41 | NCT03736044 (ClinicalTrials.gov) | November 25, 2013 | 11/10/2018 | Reconstitution of CD4+CD25highCD127low/-Tcell | Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy | Rheumatoid Arthritis | Drug: TNF-blockers suspension in patients with rheumatoid arthritis | University Hospital of Ferrara | NULL | Completed | 18 Years | N/A | All | 48 | Phase 1 | NULL |
| 42 | EUCTR2011-005648-93-GB (EUCTR) | 12/07/2013 | 30/05/2013 | A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints. | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Protocol Ref: CD-IA-CAM-3001-1109 - An Open-label of Mavrilimumab in Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab | MedImmune Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany | ||
| 43 | EUCTR2011-005649-10-GB (EUCTR) | 05/07/2013 | 11/03/2013 | An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor. | A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: mavrilimumab Product Code: CAM-3001 INN or Proposed INN: mavrilimumab Trade Name: Simponi Product Name: Golimumab INN or Proposed INN: GOLIMUMAB | MedImmune Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany | ||
| 44 | EUCTR2012-003057-29-CZ (EUCTR) | 02/04/2013 | 12/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml) | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Hungary;Czech Republic;Slovakia | ||
| 45 | EUCTR2011-002067-20-GR (EUCTR) | 10/01/2013 | 13/12/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 46 | NCT01721044 (ClinicalTrials.gov) | January 2013 | 1/11/2012 | A Moderate to Severe Rheumatoid Arthritis Study | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 527 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India |
| 47 | NCT01721057 (ClinicalTrials.gov) | December 2012 | 1/11/2012 | A Study in Moderate to Severe Rheumatoid Arthritis Participants | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo;Drug: Baricitinib;Drug: cDMARD | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 684 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic |
| 48 | EUCTR2012-003057-29-HU (EUCTR) | 13/11/2012 | 19/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Czech Republic;Hungary;Slovakia | ||
| 49 | EUCTR2012-003057-29-SK (EUCTR) | 12/11/2012 | 19/09/2012 | A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis. | A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients | XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis. MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: XmAb5871_10.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_3.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_1.0MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Product Name: XmAb5871_0.3MG Product Code: XENP5871 INN or Proposed INN: XmAb®5871 Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. | Xencor Inc. | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | Hungary;Czech Republic;Slovakia | ||
| 50 | NCT04704492 (ClinicalTrials.gov) | August 14, 2012 | 6/1/2021 | A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis | An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Biological: SM03 | SinoMab Pty Ltd | NULL | Completed | 18 Years | 65 Years | All | 8 | Phase 1 | China |
| 51 | EUCTR2011-002067-20-GB (EUCTR) | 23/07/2012 | 13/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 52 | EUCTR2011-002067-20-PT (EUCTR) | 06/07/2012 | 21/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 53 | EUCTR2010-018485-24-HU (EUCTR) | 29/06/2012 | 02/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Czech Republic;Hungary;Spain;Latvia;Germany | |||
| 54 | EUCTR2011-002067-20-BG (EUCTR) | 28/06/2012 | 11/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 55 | EUCTR2011-002067-20-ES (EUCTR) | 26/06/2012 | 10/05/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 56 | EUCTR2011-002067-20-AT (EUCTR) | 26/06/2012 | 27/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 57 | EUCTR2011-002067-20-CZ (EUCTR) | 19/06/2012 | 25/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 58 | EUCTR2010-018485-24-LV (EUCTR) | 15/06/2012 | 14/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Hungary;Germany;Czech Republic;Spain;Latvia | |||
| 59 | EUCTR2011-002067-20-DE (EUCTR) | 13/06/2012 | 16/02/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | Ireland;Austria;Italy;United States;Portugal;Greece;Spain;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 60 | EUCTR2011-001729-25-NL (EUCTR) | 11/06/2012 | 05/03/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 61 | EUCTR2011-002067-20-IE (EUCTR) | 01/06/2012 | 10/04/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | Phase 4 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany | ||
| 62 | EUCTR2011-001729-25-GB (EUCTR) | 01/06/2012 | 19/04/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 63 | EUCTR2011-002067-20-HU (EUCTR) | 30/05/2012 | 20/03/2012 | Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide. | A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - - | Moderate to severe rheumatoid arthritis MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 892 | United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany | |||
| 64 | EUCTR2011-001729-25-SE (EUCTR) | 22/05/2012 | 22/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 65 | EUCTR2011-001729-25-DE (EUCTR) | 11/04/2012 | 10/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Argentina;Brazil;Australia;Netherlands;Germany;Sweden;Canada;Mexico;Czech Republic;Hungary;Switzerland;Italy;United Kingdom;Colombia;Austria;Ireland;Spain;United States | |||
| 66 | EUCTR2011-001729-25-CZ (EUCTR) | 03/04/2012 | 03/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 67 | EUCTR2011-004171-36-ES (EUCTR) | 30/03/2012 | 30/01/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of | |||
| 68 | EUCTR2011-004171-36-PL (EUCTR) | 29/03/2012 | 22/02/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 69 | EUCTR2011-001729-25-HU (EUCTR) | 22/03/2012 | 26/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 70 | EUCTR2011-001729-25-ES (EUCTR) | 16/03/2012 | 27/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 71 | EUCTR2011-001729-25-IE (EUCTR) | 09/03/2012 | 12/01/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | ||
| 72 | EUCTR2011-001729-25-AT (EUCTR) | 08/03/2012 | 08/02/2012 | Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis. | A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - - | Early active rheumatoid arthritis MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden | |||
| 73 | EUCTR2011-004171-36-GB (EUCTR) | 24/02/2012 | 15/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 74 | EUCTR2011-004171-36-HU (EUCTR) | 23/02/2012 | 16/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Poland;Spain;Korea, Republic of;Romania;Mexico;Argentina;Taiwan;Canada;Czech Republic;Russian Federation;United Kingdom;Brazil;South Africa;Turkey;Switzerland;Hungary | |||
| 75 | EUCTR2011-004171-36-CZ (EUCTR) | 15/02/2012 | 30/11/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 76 | JPRN-UMIN000006702 | 2012/02/01 | 11/11/2011 | A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis | rheumatoid arthritis | Intensive treatment group Period: 24 weeks In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. Conventional treatment group Period: 24 weeks In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. | Tokyo Medical and Dental University | Department of Pharmacovigilance | Complete: follow-up continuing | 20years-old | 70years-old | Male and Female | 290 | Not applicable | Japan | |
| 77 | NCT01533714 (ClinicalTrials.gov) | January 2012 | 10/2/2012 | The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis | Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083 | Rheumatoid Arthritis | Biological: Olokizumab | UCB Pharma | NULL | Completed | 20 Years | N/A | Both | 103 | Phase 2 | Japan;Korea, Republic of;Taiwan |
| 78 | NCT01451203 (ClinicalTrials.gov) | October 11, 2011 | 25/9/2011 | Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors | Rheumatoid Arthritis | Drug: Placebo;Drug: CZP;Drug: methotrexate (MTX) | Astellas Pharma Inc | UCB Japan Co. Ltd. | Completed | 20 Years | 64 Years | All | 319 | Phase 3 | Japan |
| 79 | NCT01463059 (ClinicalTrials.gov) | October 2011 | 27/10/2011 | Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy | Rheumatoid Arthritis | Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg | UCB Japan Co. Ltd. | NULL | Completed | 20 Years | N/A | Both | 119 | Phase 2 | Japan;Korea, Republic of;Taiwan |
| 80 | EUCTR2010-022378-15-GB (EUCTR) | 18/08/2011 | 10/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 81 | NCT01390545 (ClinicalTrials.gov) | August 2011 | 5/7/2011 | VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis | VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate. | Rheumatoid Arthritis | Drug: Veltuzumab | Takeda | NULL | Terminated | 18 Years | N/A | Both | 300 | Phase 2 | United States;Argentina;Canada;Czech Republic;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom |
| 82 | EUCTR2010-022378-15-DE (EUCTR) | 25/05/2011 | 09/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 83 | EUCTR2010-022378-15-ES (EUCTR) | 19/05/2011 | 21/02/2011 | A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 84 | EUCTR2010-018485-24-DE (EUCTR) | 18/05/2011 | 28/01/2011 | To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 176 | Hungary;Czech Republic;Spain;Latvia;Germany | |||
| 85 | EUCTR2009-013758-33-NL (EUCTR) | 10/05/2011 | 16/09/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 86 | EUCTR2010-022224-77-BE (EUCTR) | 10/05/2011 | 14/01/2011 | Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 87 | EUCTR2010-020839-39-BE (EUCTR) | 10/05/2011 | 25/11/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc. A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Belgium;United Kingdom | ||
| 88 | EUCTR2010-022224-77-GB (EUCTR) | 27/04/2011 | 21/12/2010 | Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 89 | EUCTR2010-018485-24-ES (EUCTR) | 12/04/2011 | 04/11/2010 | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Hungary;Germany;Czech Republic;Spain;Latvia | |||
| 90 | EUCTR2010-022378-15-HU (EUCTR) | 08/04/2011 | 21/02/2011 | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (Immu-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom | ||
| 91 | EUCTR2010-022378-15-CZ (EUCTR) | 16/03/2011 | 21/02/2011 | A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis. | VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Veltuzumab solution 75mg/ml Product Code: hA20 (IMMU-106) INN or Proposed INN: Veltuzumab Other descriptive name: humanised anti-CD 20 antibody | Nycomed GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom | ||
| 92 | NCT01296711 (ClinicalTrials.gov) | March 2011 | 14/2/2011 | Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056 | A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056 | Rheumatoid Arthritis | Biological: CDP6038 | UCB BIOSCIENCES, Inc. | NULL | Completed | 18 Years | N/A | Both | 190 | Phase 2 | United States;Belgium;United Kingdom |
| 93 | EUCTR2010-020839-39-GB (EUCTR) | 25/02/2011 | 12/10/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;United States | |||
| 94 | NCT01339481 (ClinicalTrials.gov) | February 2011 | 13/4/2011 | A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept | A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept | Rheumatoid Arthritis | Drug: abatacept | Astellas Pharma Inc | Perseid Therapeutics LLC | Completed | 18 Years | N/A | Both | 26 | N/A | United States |
| 95 | NCT02586246 (ClinicalTrials.gov) | January 2011 | 23/10/2015 | Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 | Long-term Treatment Study of CDP870 Self-injection. A Multicenter, Open-label, Long-term Safety Study to Evaluate the Safety and Efficacy of CDP870 Self-injection Administered at a Dose of 200 mg Biweekly for 24 Weeks or Longer in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Administered Concomitantly With or Without Methotrexate (MTX) | Active Rheumatoid Arthritis | Drug: CDP870 | Astellas Pharma Inc | UCB Japan Co. Ltd. | Completed | N/A | N/A | Both | 86 | Phase 3 | Japan |
| 96 | NCT01242488 (ClinicalTrials.gov) | November 2010 | 15/11/2010 | Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy | Rheumatoid Arthritis | Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 221 | Phase 2 | United States;Belgium;United Kingdom |
| 97 | EUCTR2010-018485-24-CZ (EUCTR) | 20/10/2010 | 24/08/2010 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 128 | Hungary;Czech Republic;Spain;Latvia;Germany | |||
| 98 | EUCTR2009-013758-33-DK (EUCTR) | 09/09/2010 | 09/06/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 99 | EUCTR2009-010516-15-GR (EUCTR) | 13/07/2010 | 21/04/2010 | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid arthritis (seropositive) MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis | Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087 | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Hungary;Greece;Poland;Spain | ||
| 100 | EUCTR2009-013758-33-SE (EUCTR) | 17/06/2010 | 22/03/2010 | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia® Product Name: certolizumab pegol (CZP) Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Denmark;Netherlands;Sweden | |||
| 101 | EUCTR2009-010516-15-ES (EUCTR) | 11/05/2010 | 29/07/2009 | Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid arthritis (seropositive)Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis | Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087 | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Hungary;Greece;Poland;Spain | ||
| 102 | EUCTR2009-010516-15-PL (EUCTR) | 03/03/2010 | 21/08/2009 | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid arthritis (seropositive) MedDRA version: 13.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087 | Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Greece;Spain;Poland | |||
| 103 | NCT01197066 (ClinicalTrials.gov) | March 2010 | 17/3/2010 | Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis | A Phase ? Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i | Rheumatoid Arthritis | Drug: Certolizumab Pegol | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 110 | Phase 3 | Korea, Republic of |
| 104 | EUCTR2007-000830-38-PL (EUCTR) | 08/02/2010 | 05/01/2010 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Cimzia® Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | France;Poland;Austria;Germany;Italy | ||
| 105 | NCT01123070 (ClinicalTrials.gov) | February 2010 | 11/5/2010 | TL011 in Severe, Active Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 80 Years | Both | 48 | Phase 1/Phase 2 | Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany | |
| 106 | NCT01009242 (ClinicalTrials.gov) | October 2009 | 4/11/2009 | To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate | Arthritis;Rheumatoid Arthritis | Biological: CDP6038;Other: Placebo IV;Other: Placebo SC;Drug: CDP 6038 SC;Drug: Methotrexate | UCB Pharma | NULL | Completed | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States;Germany |
| 107 | NCT00993317 (ClinicalTrials.gov) | October 2009 | 9/10/2009 | A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis | A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Drug: Placebo of CDP870;Drug: CDP870 200mg;Drug: Methotrexate | Korea Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 127 | Phase 3 | Korea, Republic of |
| 108 | EUCTR2009-010813-57-DE (EUCTR) | 28/08/2009 | 24/06/2009 | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany | |||
| 109 | EUCTR2009-010516-15-HU (EUCTR) | 14/08/2009 | 14/07/2009 | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate | Rheumatoid arthritis (seropositive) MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis | Product Name: SBI-087 Product Code: SBI-087 INN or Proposed INN: n/a Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087 | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Greece;Poland;Spain | |||
| 110 | EUCTR2007-000828-40-PL (EUCTR) | 24/06/2009 | 12/05/2009 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Germany;France;Italy;Austria;Poland | ||
| 111 | EUCTR2008-005427-28-NL (EUCTR) | 22/04/2009 | 09/12/2008 | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 1048 | Phase 3 | Germany;Netherlands;France;Spain;Italy | ||
| 112 | EUCTR2008-005427-28-ES (EUCTR) | 03/04/2009 | 26/01/2009 | Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic | Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic | Artritis reumatoide (Rheumatoid arthritis) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 1048 | Phase 3 | Germany;Netherlands;France;Spain;Italy | ||
| 113 | EUCTR2008-005427-28-FR (EUCTR) | 02/04/2009 | 19/03/2009 | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 1048 | Phase 3 | France;Spain;Germany;Netherlands;Italy | ||
| 114 | EUCTR2007-005288-86-FR (EUCTR) | 18/03/2009 | 30/07/2008 | A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis | A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab' fragment - PEG conjugate | UCB Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 335 | Phase 3 | France | ||
| 115 | NCT00850343 (ClinicalTrials.gov) | March 2009 | 23/2/2009 | Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients | A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003) | Rheumatoid Arthritis | Drug: Certolizumab pegol | Astellas Pharma Inc | UCB Japan Co. Ltd. | Completed | 20 Years | 74 Years | All | 208 | Phase 3 | Japan |
| 116 | NCT00851318 (ClinicalTrials.gov) | March 2009 | 23/2/2009 | Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients | A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001) | Rheumatoid Arthritis | Drug: Certolizumab pegol;Drug: Methotrexate | Astellas Pharma Inc | UCB Japan Co. Ltd. | Completed | 20 Years | 74 Years | All | 285 | Phase 3 | Japan |
| 117 | EUCTR2008-005427-28-DE (EUCTR) | 27/02/2009 | 10/12/2008 | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 1048 | Phase 3 | Germany;Netherlands;France;Spain;Italy | ||
| 118 | EUCTR2008-005427-28-IT (EUCTR) | 28/01/2009 | 11/03/2009 | A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic | A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic | rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 1048 | Phase 3 | Germany;Netherlands;France;Spain;Italy | ||
| 119 | EUCTR2008-002046-27-DE (EUCTR) | 08/12/2008 | 08/07/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1/2 | Germany;Belgium;France;Spain | ||
| 120 | EUCTR2007-000830-38-DE (EUCTR) | 05/12/2008 | 29/09/2008 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | France;Poland;Austria;Germany;Italy | ||
| 121 | EUCTR2008-002046-27-BE (EUCTR) | 05/11/2008 | 17/09/2008 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 1/2 | Germany;Belgium;France;Spain | ||
| 122 | NCT00791999 (ClinicalTrials.gov) | November 2008 | 14/11/2008 | Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX. | Rheumatoid Arthritis | Drug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870 | Otsuka Pharmaceutical Co., Ltd. | UCB Japan Co. Ltd. | Completed | 20 Years | 74 Years | All | 316 | Phase 2/Phase 3 | Japan |
| 123 | NCT00791921 (ClinicalTrials.gov) | November 2008 | 14/11/2008 | Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated. | Rheumatoid Arthritis | Drug: CDP870;Drug: Placebo of CDP870 | Otsuka Pharmaceutical Co., Ltd. | UCB Japan Co. Ltd. | Completed | 20 Years | 74 Years | All | 230 | Phase 3 | Japan |
| 124 | EUCTR2007-002950-42-GB (EUCTR) | 27/10/2008 | 20/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom | ||
| 125 | EUCTR2008-002046-27-ES (EUCTR) | 14/10/2008 | 06/05/2010 | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. | Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato. | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1/2 | Germany;Belgium;France;Spain | ||
| 126 | EUCTR2007-000830-38-AT (EUCTR) | 09/10/2008 | 09/09/2008 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | France;Poland;Austria;Germany;Italy | ||
| 127 | EUCTR2007-000830-38-FR (EUCTR) | 07/10/2008 | 10/07/2008 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate | UCB Pharma S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Germany;France;Italy;Poland;Austria | ||
| 128 | EUCTR2008-001241-26-HU (EUCTR) | 18/09/2008 | 02/06/2008 | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a. | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a. | Active rheumatoid arthritis, functional class II-III MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: BT061 (CD4 monoclonal antibody) Product Code: BT971 INN or Proposed INN: BT061 (CD4 monoclonal antibody) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | |||
| 129 | EUCTR2008-002046-27-FR (EUCTR) | 05/09/2008 | 15/07/2008 | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: GSK1841157 Other descriptive name: HuMax-CD20 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 1;Phase 2 | France;Spain;Belgium;Germany | ||
| 130 | EUCTR2007-002951-18-DE (EUCTR) | 16/08/2008 | 30/06/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 131 | EUCTR2008-001241-26-BG (EUCTR) | 14/08/2008 | 27/09/2008 | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate | A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate | Active rheumatoid arthritis, functional class II-III. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: BT061 (CD4 monoclonal antibody) Product Code: BT971 | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | |||
| 132 | EUCTR2007-002951-18-GB (EUCTR) | 07/08/2008 | 14/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development | NULL | Not Recruiting | Female: yes Male: yes | 236 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden;Spain;France | ||
| 133 | EUCTR2007-002950-42-BE (EUCTR) | 25/07/2008 | 24/06/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Spain;Poland;Belgium;Lithuania;United Kingdom | ||
| 134 | EUCTR2007-000830-38-IT (EUCTR) | 30/06/2008 | 21/07/2008 | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND | A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076. - ND | rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. (Casa Madre) | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | Germany;France;Italy;Poland;Austria | ||
| 135 | EUCTR2007-002951-18-SE (EUCTR) | 11/06/2008 | 25/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | ||
| 136 | EUCTR2007-002951-18-DK (EUCTR) | 03/06/2008 | 23/04/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 137 | EUCTR2007-000828-40-DE (EUCTR) | 27/05/2008 | 10/01/2008 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Germany;France;Italy;Poland;Austria | ||
| 138 | EUCTR2007-000828-40-IT (EUCTR) | 15/05/2008 | 14/07/2008 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND | Rheumatoid arthritis with moderate to low disease activity MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB S.A. (Casa Madre) | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Germany;France;Italy;Poland;Austria | ||
| 139 | EUCTR2007-002951-18-FR (EUCTR) | 14/05/2008 | 18/03/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 140 | EUCTR2007-004878-31-HU (EUCTR) | 09/04/2008 | 20/12/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | ||
| 141 | EUCTR2007-000828-40-FR (EUCTR) | 26/02/2008 | 11/12/2007 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | France;Poland;Austria;Germany;Italy | ||
| 142 | EUCTR2007-000828-40-AT (EUCTR) | 21/02/2008 | 31/03/2008 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076 | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Germany;France;Italy;Poland;Austria | ||
| 143 | NCT00639834 (ClinicalTrials.gov) | February 2008 | 10/1/2008 | Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: MDX-1342 | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 1 | United States;Germany;Hungary;Ukraine;United Kingdom;Poland |
| 144 | EUCTR2007-002950-42-PL (EUCTR) | 09/01/2008 | 24/08/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Spain;Poland;Lithuania;United Kingdom | ||
| 145 | NCT00655824 (ClinicalTrials.gov) | January 1, 2008 | 4/4/2008 | Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403 | An Open-label, International, Multi-center, Phase II, Extension Trial Investigating Long-term Efficacy and Safety of Repeated Treatment Courses of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Adult Patients With Active Rheumatoid Arthritis Who Previously Received Ofatumumab or Placebo | Arthritis, Rheumatoid | Drug: ofatumumab | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 124 | Phase 2 | United States;Denmark;Hungary;Poland;United Kingdom |
| 146 | EUCTR2007-002951-18-NL (EUCTR) | 10/12/2007 | 09/08/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden | ||
| 147 | EUCTR2007-004878-31-DK (EUCTR) | 10/12/2007 | 09/10/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Hungary;Denmark;United Kingdom | ||
| 148 | EUCTR2007-004878-31-GB (EUCTR) | 07/12/2007 | 16/10/2007 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Denmark;United Kingdom | ||
| 149 | EUCTR2007-002951-18-ES (EUCTR) | 27/11/2007 | 11/10/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 150 | EUCTR2007-002950-42-ES (EUCTR) | 27/11/2007 | 11/10/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid ArthritisArtritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Belgium;Poland;Spain;Lithuania;United Kingdom | ||
| 151 | EUCTR2007-002945-18-IT (EUCTR) | 22/10/2007 | 07/02/2008 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies | Product Name: Ofatumumab Product Code: HuMax-CD20 | GENMAB A/S | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic;Italy | ||
| 152 | EUCTR2007-002950-42-HU (EUCTR) | 18/10/2007 | 31/07/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom | ||
| 153 | EUCTR2007-002945-18-CZ (EUCTR) | 15/10/2007 | 27/08/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Czech Republic | ||
| 154 | EUCTR2007-002950-42-CZ (EUCTR) | 15/10/2007 | 15/08/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | GlaxoSmithKline Research and Development | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Hungary;Czech Republic;Spain;Poland;Lithuania;United Kingdom | ||
| 155 | EUCTR2007-002951-18-IT (EUCTR) | 28/09/2007 | 05/10/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-alfa; antagonist therapy - ND | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-alfa; antagonist therapy - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies | Product Name: Ofatumumab Product Code: HuMax-CD20 | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 236 | Phase 3 | France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 156 | EUCTR2007-002950-42-LT (EUCTR) | 13/09/2007 | 31/07/2007 | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ofatumumab Product Code: HuMax-CD20 INN or Proposed INN: Ofatumumab | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 248 | Phase 3 | Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania | ||
| 157 | EUCTR2004-002993-49-EE (EUCTR) | 02/02/2007 | 23/02/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | |||
| 158 | NCT00396812 (ClinicalTrials.gov) | November 2006 | 6/11/2006 | Rituximab for the Treatment of Early Rheumatoid Arthritis (RA) | An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Terminated | 18 Years | N/A | All | 4 | Phase 1/Phase 2 | United States |
| 159 | EUCTR2005-002326-63-EE (EUCTR) | 09/08/2006 | 26/08/2005 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 160 | EUCTR2004-003771-37-HU (EUCTR) | 03/03/2006 | 03/11/2005 | A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | Active Rheumatoid Arthritis MedDRA version: 7.0;Level: LLT;Classification code 10039073 | Product Name: HuMax-CD20 Product Code: HuMax-CD20 INN or Proposed INN: N/A Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells | Genmab A/S | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 1/2 | Hungary | ||
| 161 | EUCTR2005-002629-30-LV (EUCTR) | 27/02/2006 | 01/03/2006 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | Rheumatoid arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 162 | EUCTR2005-002629-30-CZ (EUCTR) | 15/02/2006 | 01/02/2006 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | Rheumatoid arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 163 | EUCTR2005-002629-30-EE (EUCTR) | 13/02/2006 | 23/02/2006 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | Rheumatoid arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Czech Republic;Estonia;Lithuania;Latvia | ||
| 164 | EUCTR2005-002629-30-SK (EUCTR) | 03/02/2006 | 04/01/2006 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | Rheumatoid arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | Estonia;Czech Republic;Slovakia;Lithuania;Latvia | ||
| 165 | NCT00502996 (ClinicalTrials.gov) | February 2006 | 17/7/2007 | A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis. | Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser) | Rheumatoid Arthritis | Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 246 | Phase 3 | Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela |
| 166 | EUCTR2005-002629-30-LT (EUCTR) | 30/01/2006 | 06/12/2005 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050 | Rheumatoid arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Inc | NULL | Not Recruiting | Female: yes Male: yes | 634 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 167 | NCT00160641 (ClinicalTrials.gov) | November 2005 | 8/9/2005 | A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050 | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 567 | Phase 3 | United States;Bulgaria;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro |
| 168 | EUCTR2005-002326-63-LV (EUCTR) | 28/10/2005 | 22/11/2005 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 169 | EUCTR2005-002326-63-LT (EUCTR) | 21/09/2005 | 04/08/2005 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 170 | EUCTR2005-002326-63-SK (EUCTR) | 20/09/2005 | 05/08/2005 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 590 | Phase 3 | Estonia;Czech Republic;Slovakia;Lithuania;Latvia | ||
| 171 | EUCTR2005-002326-63-CZ (EUCTR) | 05/09/2005 | 08/08/2005 | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 634 | Phase 3 | Czech Republic;Estonia;Latvia;Lithuania | ||
| 172 | EUCTR2005-001350-24-FI (EUCTR) | 04/08/2005 | 23/06/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania | ||
| 173 | EUCTR2005-001350-24-HU (EUCTR) | 01/08/2005 | 19/05/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania | ||
| 174 | EUCTR2005-001350-24-EE (EUCTR) | 18/07/2005 | 14/06/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia | ||
| 175 | EUCTR2005-001350-24-LT (EUCTR) | 14/07/2005 | 08/06/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania | ||
| 176 | EUCTR2005-001350-24-LV (EUCTR) | 21/06/2005 | 21/06/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania | ||
| 177 | EUCTR2004-002993-49-DE (EUCTR) | 10/06/2005 | 25/01/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | Celltech R&D Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | |||
| 178 | NCT00175877 (ClinicalTrials.gov) | June 2005 | 9/9/2005 | A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis | A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 857 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Estonia;Finland;France;Hungary;Israel;Latvia;Lithuania;Mexico;New Zealand;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro;Netherlands;Spain;Sweden |
| 179 | EUCTR2005-001350-24-SK (EUCTR) | 31/05/2005 | 21/04/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia | ||
| 180 | EUCTR2005-001350-24-CZ (EUCTR) | 27/05/2005 | 04/05/2005 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027 | Rheumatoid arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: Certolizumab pegol Other descriptive name: CDP870 Fab'-PEG | UCB Inc. | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania | ||
| 181 | EUCTR2004-002993-49-GB (EUCTR) | 17/05/2005 | 23/02/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | Celltech R&D Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;United Kingdom;Estonia;Latvia;Sweden;Lithuania | ||
| 182 | EUCTR2004-002993-49-BE (EUCTR) | 05/05/2005 | 19/07/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | Celltech R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Estonia;Czech Republic;Hungary;Finland;Belgium;Lithuania;Latvia;Sweden | ||
| 183 | EUCTR2004-002993-49-FI (EUCTR) | 29/03/2005 | 16/12/2004 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 | Celltech R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden | ||
| 184 | EUCTR2004-002993-49-SE (EUCTR) | 15/03/2005 | 05/01/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania;Sweden | |||
| 185 | EUCTR2004-002993-49-LV (EUCTR) | 28/02/2005 | 28/02/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | Celltech R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | |||
| 186 | EUCTR2004-002993-49-CZ (EUCTR) | 11/02/2005 | 04/02/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Germany;Czech Republic;Estonia;Latvia;Sweden;Lithuania | |||
| 187 | EUCTR2004-002993-49-HU (EUCTR) | 11/02/2005 | 15/12/2004 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | Celltech R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | |||
| 188 | EUCTR2004-002993-49-LT (EUCTR) | 09/02/2005 | 03/01/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania | |||
| 189 | EUCTR2004-002993-49-SK (EUCTR) | 08/02/2005 | 31/01/2005 | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study | Rheumatoid Arthritis Classification code 10039073 | Product Name: CDP870 Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden | ||
| 190 | NCT00291928 (ClinicalTrials.gov) | February 2005 | 14/2/2006 | HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II | A Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs | Arthritis, Rheumatoid | Drug: Part A;Drug: Part B | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | Both | 201 | Phase 2 | United States;Denmark;Finland;France;Hungary;Poland;United Kingdom |
| 191 | NCT00152386 (ClinicalTrials.gov) | February 2005 | 7/9/2005 | A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis | A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate | Rheumatoid Arthritis | Drug: Certolizumab pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 950 | Phase 3 | Croatia;Czechia;Israel;Latvia;Russian Federation;Ukraine;United States;Czech Republic;Argentina;Australia;Belgium;Bulgaria;Canada;Chile |
| 192 | NCT00548834 (ClinicalTrials.gov) | June 2003 | 15/10/2007 | Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis | Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD | Rheumatoid Arthritis | Drug: CDP870 | UCB Pharma | NULL | Completed | 18 Years | 75 Years | Both | 220 | Phase 3 | NULL |
| 193 | NCT00160693 (ClinicalTrials.gov) | March 2003 | 6/9/2005 | Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis | A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Certolizumab Pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 402 | Phase 3 | United Kingdom;Austria;Belgium;Czechia;Germany;Ireland;United States;Czech Republic |
| 194 | NCT00544154 (ClinicalTrials.gov) | October 2002 | 15/10/2007 | Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis | Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate | Arthritis, Rheumatoid | Drug: CDP870 | UCB Pharma | NULL | Completed | 18 Years | 75 Years | Both | 247 | Phase 3 | NULL |
| 195 | NCT00042406 (ClinicalTrials.gov) | September 2002 | 29/7/2002 | Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker | A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-alpha Blocking Agents | Rheumatoid Arthritis | Drug: HuMax-CD4 | Emergent Product Development Seattle LLC | NULL | Terminated | 18 Years | N/A | Both | 75 | Phase 2/Phase 3 | United States;Canada |
| 196 | NCT02247375 (ClinicalTrials.gov) | January 2000 | 19/9/2014 | Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA) | A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks | Arthritis, Rheumatoid | Drug: Low dose of BIIL 284 BS tablets;Drug: High dose of BIIL 284 BS tablets;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 65 Years | Both | 26 | Phase 1 | NULL |
| 197 | JPRN-JapicCTI-132156 | 12/06/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. | Eli Lilly Japan K.K. | NULL | recruiting | 18 | BOTH | Phase 3 | NULL | |||
| 198 | JPRN-JapicCTI-132138 | 28/05/2013 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : Baricitinib Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. Control intervention name : Placebo Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study. | Eli Lilly Japan K.K. | NULL | 18 | BOTH | Phase 3 | NULL |
51. Scleroderma
Clinical trials : 523 / Drugs : 608 - (DrugBank : 156) / Drug target genes : 114 - Drug target pathways : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05270668 (ClinicalTrials.gov) | February 22, 2022 | 27/2/2022 | Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | Diffuse Cutaneous Systemic Sclerosis;Interstitial Lung Disease | Drug: PRA023 IV;Device: Companion diagnostic ( CDx);Drug: Placebo | Prometheus Biosciences, Inc. | PPD | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States |
| 2 | NCT05029336 (ClinicalTrials.gov) | December 2021 | 24/8/2021 | Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases | Systemic Lupus Erythematosus;Systemic Sclerosis | Biological: Depletion of CD3/CD19 in an autologous stem cell transplant | Stephan Grupp MD PhD | NULL | Recruiting | 8 Years | 25 Years | All | 20 | Phase 2 | United States |
| 3 | NCT05085444 (ClinicalTrials.gov) | October 8, 2021 | 11/10/2021 | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | Scleroderma;Autoimmune Diseases | Biological: Assigned Interventions CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 9 | Early Phase 1 | China |
| 4 | JPRN-jRCTc071190041 | 04/01/2019 | 09/01/2020 | A clinical trial of autologous stem cell transplantation for severe systemic sclerosis | A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis | systemic sclerosis | After peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted. | Akashi Koichi | NULL | Recruiting | >= 16age old | < 65age old | Both | 12 | Phase 2 | Japan |
| 5 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 6 | NCT01895244 (ClinicalTrials.gov) | September 2012 | 1/7/2013 | Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation | Scleroderma;Cardiac Involvement;Autologous Stem Cell Transplantation | Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells | University Hospital Tuebingen | NULL | Recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany |
| 7 | EUCTR2011-002434-40-DE (EUCTR) | 23/03/2012 | 18/08/2011 | Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the disease | Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosisModification according to manifestation - AST-MOMA | Systemic sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10059040;Term: Autologous peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CD34 selected autologous hematopoietic cells Product Code: CD34+SC | University Hospital Tuebingen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 8 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
| 9 | NCT00936546 (ClinicalTrials.gov) | June 2009 | 9/7/2009 | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis) | Drug: Rituximab | University Hospital, Ghent | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | Belgium |
| 10 | EUCTR2008-007180-16-NL (EUCTR) | 13/05/2009 | 24/11/2008 | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | systemic sclerosis MedDRA version: 9.1;Level: PT;Classification code 10039710;Term: Scleroderma | Trade Name: Rituximab Product Name: Mabthera | LUMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 11 | NCT00379431 (ClinicalTrials.gov) | November 2006 | 20/9/2006 | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | Early and Severe Systemic Sclerosis | Drug: Administration of rituximab and methylprednisolone | University Hospital, Ghent | NULL | Active, not recruiting | 18 Years | N/A | Both | 40 | Phase 2 | Belgium |
| 12 | EUCTR2006-003836-31-BE (EUCTR) | 06/09/2006 | 02/08/2006 | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | systemic sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 13 | NCT00114530 (ClinicalTrials.gov) | June 2005 | 15/6/2005 | Scleroderma: Cyclophosphamide or Transplantation (SCOT) | A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01) | Scleroderma, Systemic;Sclerosis;Autoimmune Disease | Biological: mHSCT;Drug: cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 75 | Phase 2/Phase 3 | United States;Canada |
96. Crohn disease
Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05284136 (ClinicalTrials.gov) | April 1, 2022 | 28/2/2022 | Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease | Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE | Crohn Disease | Dietary Supplement: Crohn's disease exclusion diet (CDED);Drug: Oral prednisolone | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 16 Years | 70 Years | All | 80 | Phase 2/Phase 3 | France;Netherlands |
| 2 | EUCTR2021-002869-18-BE (EUCTR) | 14/03/2022 | 25/10/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 3 | NCT05239702 (ClinicalTrials.gov) | February 28, 2022 | 1/12/2021 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases | Crohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune Diseases | Biological: CD7 CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 4 | NCT04779320 (ClinicalTrials.gov) | February 28, 2022 | 1/3/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease (CD) | Drug: Vedolizumab IV | Takeda | NULL | Not yet recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | NULL |
| 5 | EUCTR2021-002869-18-GR (EUCTR) | 18/02/2022 | 16/11/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 6 | EUCTR2021-002869-18-CZ (EUCTR) | 10/02/2022 | 30/11/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 7 | NCT04777656 (ClinicalTrials.gov) | February 2022 | 26/2/2021 | Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. | Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone. | Crohn's Disease | Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy;Dietary Supplement: Phase2 and 3 : | Assistance Publique - Hôpitaux de Paris | URC-CIC Paris Descartes Necker Cochin;MICALIS Institute | Not yet recruiting | 6 Years | 17 Years | All | 120 | Phase 3 | France |
| 8 | NCT05068284 (ClinicalTrials.gov) | January 31, 2022 | 27/9/2021 | A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD | Crohn's Disease | Drug: ABBV-154;Drug: Placebo | AbbVie | NULL | Recruiting | 18 Years | 75 Years | All | 265 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom |
| 9 | EUCTR2021-002869-18-ES (EUCTR) | 20/01/2022 | 15/09/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 10 | JPRN-jRCT2071210031 | 15/01/2022 | 01/06/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >=30 kg will be included in this arm group Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this armgroup. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q | Shikamura Mitsuhiro | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania;New Zealand;Poland;Romania;Slovakia;Russia;Ukraine;Spain;United Kingdom;China;Japan |
| 11 | NCT04530877 (ClinicalTrials.gov) | January 1, 2022 | 24/8/2020 | Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients | Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease | Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing | Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition | Children's Hospital of Fudan University | NULL | Not yet recruiting | 1 Year | 18 Years | All | 80 | Phase 4 | NULL |
| 12 | NCT04779762 (ClinicalTrials.gov) | January 2022 | 28/2/2021 | Stelara and Diet Trial for Crohns Disease | Stelara and CDED Diet Trial for Crohns Disease | Crohn Disease | Other: Crohn's disease exclusion diet (CDED);Drug: Ustekinumab Injection [Stelara] | Wolfson Medical Center | Sheba Medical Center, Israel | Not yet recruiting | 18 Years | 65 Years | All | 40 | N/A | Israel |
| 13 | EUCTR2020-004527-16-IT (EUCTR) | 21/12/2021 | 29/09/2021 | A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s Disease | A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment - InCharge | Crohn`s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Stelara 130mg / 26mL concentrate for solution for infusion Product Name: Stelara 130mg / 26mL concentrate for solution for infusion Product Code: [Stelara 130mg / 26mL concentrate for solution for INN or Proposed INN: USTEKINUMAB Product Name: BI 706321 Product Code: [BI 706321] Product Name: BI 706321 Product Code: [BI 706321] Product Name: BI 706321 Product Code: [BI 706321] Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML Product Name: Stelara 90mg/1ml solution for injection in pre-filled syringe (PFS) Product Code: [Stelara 90mg/1ml solution for injecti | BOEHRINGER INGELHEIM INTERNATIONAL GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | France;United States;Czechia;Spain;Poland;Belgium;Italy | ||
| 14 | NCT04186247 (ClinicalTrials.gov) | December 2021 | 2/12/2019 | Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD) | Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot Study | Crohn Disease;Pediatric Crohns Disease | Drug: Azithromycin;Drug: Metronidazole;Other: Standard of Care | University of North Carolina, Chapel Hill | Crohn's and Colitis Foundation;University of Amsterdam | Not yet recruiting | 3 Years | 17 Years | All | 20 | Phase 2 | United States;Canada;Israel;Netherlands |
| 15 | NCT04835506 (ClinicalTrials.gov) | November 1, 2021 | 5/4/2021 | Proactive IFX Optimization vs SOC in Patients With CD | Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE Trial | Crohn Disease | Drug: Infliximab | Beth Israel Deaconess Medical Center | The Leona M. and Harry B. Helmsley Charitable Trust;Icahn School of Medicine at Mount Sinai | Recruiting | 16 Years | N/A | All | 196 | Phase 4 | United States |
| 16 | NCT04626947 (ClinicalTrials.gov) | October 30, 2021 | 29/9/2020 | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. Infections | Biological: Bezlotoxumab | David Binion, MD | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 17 | NCT05028946 (ClinicalTrials.gov) | October 28, 2021 | 24/8/2021 | A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease | A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: Foralumab | Tiziana Life Sciences, PLC | NULL | Not yet recruiting | 18 Years | 70 Years | All | 16 | Phase 1 | NULL |
| 18 | EUCTR2020-004301-31-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - - | Moderately to severely active Crohn's disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 19 | EUCTR2021-000469-33-NL (EUCTR) | 12/10/2021 | 25/03/2021 | Scientific medical research comparing the effectiveness of Infliximab by injection in the abdominal tissiue (subcutaneous) monotherapy and infliximab subcutaneous injection with anti-inflammatory drugs in the treatment of moderate to severe chronic inflammatory bowel disease. | A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease. - DIRECT CD | Crohns disease;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Remsima Product Name: Remsima Product Code: EMEA/H/C/002576 Trade Name: Puri Nethol Product Name: Puri Nethol Product Code: RVG00859 Trade Name: Imuran Product Name: Imuran Trade Name: Thiosix Product Name: Thiosix Product Code: RVG 114681 Trade Name: Ebetrex 15 mg = 0,75 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml Product Name: Ebetrex Product Code: RVG 116648 | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3;Phase 4 | Netherlands | ||
| 20 | NCT04978493 (ClinicalTrials.gov) | October 4, 2021 | 26/7/2021 | A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease | A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment | Crohn Disease | Drug: BI 706321;Drug: ustekinumab;Drug: Placebo | Boehringer Ingelheim | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States;Poland |
| 21 | EUCTR2020-004301-31-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary | ||
| 22 | EUCTR2020-004461-40-IT (EUCTR) | 15/09/2021 | 18/10/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - | moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: [BMS-986165] INN or Proposed INN: deucravacitinib | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 23 | EUCTR2020-004301-31-HR (EUCTR) | 17/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 24 | EUCTR2020-004301-31-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 25 | EUCTR2020-004461-40-DE (EUCTR) | 04/08/2021 | 12/05/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis | moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: BMS-986165 INN or Proposed INN: deucravacitinib Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States | ||
| 26 | NCT05013905 (ClinicalTrials.gov) | July 28, 2021 | 13/8/2021 | A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease | A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: PRA023 IV;Device: Companion diagnostic (CDx) | Prometheus Biosciences, Inc. | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 27 | EUCTR2020-004301-31-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 28 | EUCTR2020-004301-31-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 29 | EUCTR2017-000725-12-DK (EUCTR) | 07/04/2021 | 14/10/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 30 | EUCTR2017-000725-12-SE (EUCTR) | 30/03/2021 | 20/08/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 31 | NCT04496063 (ClinicalTrials.gov) | November 16, 2020 | 29/6/2020 | USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) | USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study | Crohn's Disease | Drug: Ustekinumab;Drug: Placebo | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Janssen, LP | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 32 | EUCTR2017-003090-34-DK (EUCTR) | 12/11/2020 | 15/06/2020 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Denmark;Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Austria | ||
| 33 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 34 | NCT04524611 (ClinicalTrials.gov) | September 30, 2020 | 20/8/2020 | Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) | A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy | Crohn's Disease (CD) | Drug: Risankizumab;Drug: Ustekinumab | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 508 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 35 | ChiCTR2000037094 | 2020-09-01 | 2020-08-26 | Discovery and detection of a novel antigen for Crohn’s disease (CD) | Discovery and detection of a novel antigen for Crohn’s disease (CD) | Inflammatory Bowel Disease | Gold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA; | The First Affiliated Hospital of Anhui Medical University | NULL | Completed | 18 | 80 | Both | Target condition:100;Difficult condition:100 | China | |
| 36 | NCT04976491 (ClinicalTrials.gov) | August 1, 2020 | 14/11/2019 | Based on the Special Disease Management of Crohn's Disease Diet Studies | Based on the Special Disease Management of Crohn's Disease Diet Studies --a Multicenter, Randomized, Controlled and Open Label Study | Inflammatory Bowel Diseases | Dietary Supplement: CD-C-Food | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 6 Years | 15 Years | All | 5 | China | |
| 37 | EUCTR2017-001240-35-FR (EUCTR) | 22/06/2020 | 09/03/2020 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;China;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia | ||
| 38 | EUCTR2019-004219-29-NL (EUCTR) | 21/04/2020 | 04/02/2020 | Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease | Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ | Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Azithromycin Product Name: Azithromycin INN or Proposed INN: Azithromycin Other descriptive name: AZITHROMYCIN Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: METRONIDAZOLE | Amsterdam UMC | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Canada;Israel;Netherlands | ||
| 39 | EUCTR2019-001337-13-FR (EUCTR) | 18/03/2020 | 02/03/2020 | USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study | USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP | patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: STELARA Trade Name: STELARA 90 mg solution for injection in pre-filled syringe | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 4 | France | ||
| 40 | ChiCTR2000029543 | 2020-02-08 | 2020-02-03 | A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease | A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease | Crohn's Disease | Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines; | The First Hospital Affiliated to Sun Yat sen University | NULL | Recruiting | Both | Target condition:350;Difficult condition:0 | China | |||
| 41 | NCT04225689 (ClinicalTrials.gov) | January 10, 2020 | 20/12/2019 | The Intensive Post Exclusive Enteral Nutrition Study | The Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's Disease | Crohn Disease | Other: CD-TREAT diet | NHS Greater Glasgow and Clyde | University of Glasgow | Recruiting | 6 Years | 17 Years | All | 58 | N/A | United Kingdom |
| 42 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 43 | EUCTR2017-001240-35-SI (EUCTR) | 27/11/2019 | 12/11/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 44 | NCT04213729 (ClinicalTrials.gov) | November 26, 2019 | 24/12/2019 | Diet Intervention for Crohn's Disease Patient | A Holistic Diet Intervention for People With Crohn's Disease | Crohn Disease | Behavioral: Diet Counseling;Other: CD LFD;Behavioral: Dyadic Psychological Support (DPS) | University of Miami | The Leona M. and Harry B. Helmsley Charitable Trust | Recruiting | 18 Years | 70 Years | All | 300 | N/A | United States |
| 45 | EUCTR2018-001895-39-HR (EUCTR) | 21/11/2019 | 20/01/2020 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 46 | ChiCTR1900027370 | 2019-11-11 | 2019-11-10 | The pathogenic genes and flora of Crohn's disease with anal fistula | The pathogenic genes and flora of Crohn's disease with anal fistula | Crohn's disease with anal fistula | CD anal fistula and CD without anal fistula:N/A; | Nanfang Hospital, Southern Medical University | NULL | Recruiting | Both | CD anal fistula and CD without anal fistula:50; | N/A | China | ||
| 47 | EUCTR2018-005086-39-HU (EUCTR) | 28/10/2019 | 08/04/2019 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 48 | EUCTR2018-005086-39-PL (EUCTR) | 07/10/2019 | 06/05/2019 | A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 49 | EUCTR2018-001895-39-NL (EUCTR) | 27/09/2019 | 03/06/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 50 | EUCTR2018-001895-39-BG (EUCTR) | 05/09/2019 | 16/07/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 51 | EUCTR2017-000725-12-DE (EUCTR) | 17/07/2019 | 28/02/2019 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 52 | EUCTR2017-001226-18-SI (EUCTR) | 15/07/2019 | 06/03/2019 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden;Portugal | ||
| 53 | NCT04089514 (ClinicalTrials.gov) | June 30, 2019 | 12/9/2019 | A Real-world Study of Imraldi® Use | Pan-EU Real-World Experience With Imraldi® | Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC) | Drug: Adalimumab | Biogen | NULL | Completed | 18 Years | N/A | All | 1000 | Belgium;Germany;Ireland;Italy;Spain;United Kingdom | |
| 54 | EUCTR2017-004997-32-DE (EUCTR) | 25/06/2019 | 14/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 55 | EUCTR2018-001895-39-CZ (EUCTR) | 06/06/2019 | 05/03/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 2 | United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 56 | NCT03559660 (ClinicalTrials.gov) | May 20, 2019 | 5/6/2018 | CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Crohn's Disease | Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | NULL | Available | 18 Years | N/A | All | NULL | ||
| 57 | EUCTR2017-003090-34-HU (EUCTR) | 10/05/2019 | 25/03/2019 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Belgium;Austria;Netherlands;Germany | ||
| 58 | ChiCTR1900022728 | 2019-05-01 | 2019-04-23 | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Crohn's disease | Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD; | The 7th Medical Center of the PLA General Hospital (Army general hospital) | NULL | Pending | Both | Target condition:310;Difficult condition:160 | China | |||
| 59 | NCT03808103 (ClinicalTrials.gov) | May 1, 2019 | 4/1/2019 | Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease | A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD) | Crohn Disease | Biological: Placebo;Biological: Bacteriophage preparation | Intralytix, Inc. | MOUNT SINAI HOSPITAL | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 60 | EUCTR2017-001225-41-SI (EUCTR) | 19/04/2019 | 06/03/2019 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 61 | EUCTR2017-000725-12-GB (EUCTR) | 17/04/2019 | 22/10/2018 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 62 | EUCTR2017-003090-34-NL (EUCTR) | 16/04/2019 | 19/12/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Netherlands BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of | ||
| 63 | EUCTR2018-001272-37-HR (EUCTR) | 05/04/2019 | 17/05/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 64 | EUCTR2017-001240-35-IE (EUCTR) | 08/03/2019 | 05/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 65 | EUCTR2017-001226-18-IE (EUCTR) | 08/03/2019 | 05/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 66 | EUCTR2017-001225-41-IE (EUCTR) | 08/03/2019 | 13/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 67 | EUCTR2017-000617-23-GB (EUCTR) | 28/02/2019 | 11/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 68 | EUCTR2017-000575-88-GB (EUCTR) | 28/02/2019 | 11/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1032 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan | ||
| 69 | EUCTR2017-000576-29-GR (EUCTR) | 26/02/2019 | 25/02/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 70 | EUCTR2017-000617-23-GR (EUCTR) | 26/02/2019 | 21/02/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 71 | EUCTR2018-001272-37-PT (EUCTR) | 25/02/2019 | 30/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 72 | EUCTR2018-001272-37-AT (EUCTR) | 25/02/2019 | 21/09/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 73 | EUCTR2017-003090-34-DE (EUCTR) | 18/02/2019 | 15/11/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria | ||
| 74 | EUCTR2017-000575-88-IT (EUCTR) | 11/02/2019 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MadCam Antibody Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 75 | EUCTR2017-000617-23-IT (EUCTR) | 11/02/2019 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Phase 3 | Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Portugal;Serbia;United States | ||
| 76 | NCT03627091 (ClinicalTrials.gov) | February 6, 2019 | 24/7/2018 | Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307) | Crohn's Disease | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Completed | 16 Years | 80 Years | All | 40 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom |
| 77 | EUCTR2017-003090-34-AT (EUCTR) | 05/02/2019 | 11/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 78 | EUCTR2017-004997-32-HU (EUCTR) | 04/02/2019 | 04/04/2019 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 79 | EUCTR2017-004997-32-NL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 80 | NCT03850600 (ClinicalTrials.gov) | January 30, 2019 | 15/2/2019 | Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease | The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease | Crohn Disease;Pregnancy | Other: Diet-CD | Icahn School of Medicine at Mount Sinai | The Leona M. and Harry B. Helmsley Charitable Trust;University of Massachusetts, Worcester | Recruiting | 18 Years | N/A | Female | 396 | N/A | United States |
| 81 | EUCTR2017-000617-23-HR (EUCTR) | 11/01/2019 | 16/05/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 82 | EUCTR2017-000575-88-HR (EUCTR) | 11/01/2019 | 16/05/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | New Zealand;Japan;Netherlands;Germany;South Africa;Australia;Croatia;Romania;Poland;Brazil;Czech Republic;Italy;United Kingdom;Israel;Russian Federation;Austria;Lithuania;Czechia;Serbia;United States | ||
| 83 | EUCTR2018-001272-37-FR (EUCTR) | 10/01/2019 | 23/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 84 | EUCTR2017-004997-32-IT (EUCTR) | 10/01/2019 | 18/06/2021 | Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) Product Code: [NA] | GENENTECH, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 85 | EUCTR2017-004997-32-GB (EUCTR) | 04/01/2019 | 09/10/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 86 | EUCTR2017-001225-41-HR (EUCTR) | 31/12/2018 | 21/05/2019 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 87 | EUCTR2017-001240-35-HR (EUCTR) | 20/12/2018 | 21/05/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 88 | EUCTR2017-001226-18-HR (EUCTR) | 19/12/2018 | 21/05/2019 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 645 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 89 | EUCTR2017-004997-32-IE (EUCTR) | 14/12/2018 | 13/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: efmarodocokin alfa INN or Proposed INN: efmarodocokin alfa Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 90 | EUCTR2018-002001-65-GB (EUCTR) | 13/12/2018 | 01/10/2018 | A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s Disease | A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1070806 INN or Proposed INN: GSK1070806 Other descriptive name: fully humanised, recombinant monoclonal antibody (IgG1) | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 91 | EUCTR2017-004997-32-ES (EUCTR) | 10/12/2018 | 17/09/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 92 | EUCTR2018-001272-37-DE (EUCTR) | 04/12/2018 | 26/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 93 | EUCTR2018-001272-37-GR (EUCTR) | 28/11/2018 | 09/11/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 94 | EUCTR2017-003090-34-BE (EUCTR) | 28/11/2018 | 12/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 95 | EUCTR2018-001272-37-GB (EUCTR) | 15/11/2018 | 03/10/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 96 | EUCTR2017-000575-88-DE (EUCTR) | 13/11/2018 | 28/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan;Lithuania;Austria;Russian Federation;Israel;United States;Serbia | ||
| 97 | EUCTR2017-000617-23-DE (EUCTR) | 13/11/2018 | 28/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 98 | EUCTR2018-001272-37-ES (EUCTR) | 11/11/2018 | 09/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 99 | EUCTR2018-001272-37-HU (EUCTR) | 16/10/2018 | 16/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 100 | EUCTR2018-001272-37-BG (EUCTR) | 09/10/2018 | 31/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 101 | EUCTR2017-000617-23-PT (EUCTR) | 08/10/2018 | 01/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 102 | EUCTR2017-000576-29-BE (EUCTR) | 08/10/2018 | 02/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 103 | EUCTR2017-000617-23-BE (EUCTR) | 08/10/2018 | 02/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 104 | EUCTR2017-003359-43-DE (EUCTR) | 04/10/2018 | 19/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 105 | EUCTR2017-000617-23-EE (EUCTR) | 03/10/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 106 | EUCTR2017-003359-43-AT (EUCTR) | 24/09/2018 | 20/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 107 | EUCTR2017-000617-23-NL (EUCTR) | 17/09/2018 | 17/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 108 | EUCTR2017-000575-88-NL (EUCTR) | 17/09/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | ||
| 109 | EUCTR2017-000576-29-BG (EUCTR) | 14/09/2018 | 24/07/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 110 | EUCTR2017-000617-23-BG (EUCTR) | 14/09/2018 | 10/07/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 111 | EUCTR2017-001226-18-BE (EUCTR) | 13/09/2018 | 02/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | South Africa;Latvia;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 112 | EUCTR2017-001240-35-BE (EUCTR) | 13/09/2018 | 02/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Malaysia;Denmark;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 113 | EUCTR2017-001225-41-BE (EUCTR) | 13/09/2018 | 19/12/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;Egypt;United Kingdom;Austria;Turkey;Lithuania;Slovenia;Korea, Republic of;Bosnia and Herzegovina;China;Latvia;Netherlands;South Africa;Australia;Denmark;Malaysia;Puerto Rico;Switzerland | ||
| 114 | EUCTR2017-001226-18-CZ (EUCTR) | 12/09/2018 | 19/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | United Kingdom;Egypt;Hungary;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 115 | EUCTR2017-001225-41-CZ (EUCTR) | 12/09/2018 | 20/04/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 116 | EUCTR2017-000576-29-PT (EUCTR) | 27/08/2018 | 01/06/2018 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 117 | NCT03452501 (ClinicalTrials.gov) | August 26, 2018 | 26/2/2018 | Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients | An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD | Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | NULL | Completed | 18 Years | N/A | All | 157 | Saudi Arabia | |
| 118 | EUCTR2017-001225-41-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 119 | EUCTR2017-001226-18-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel | ||
| 120 | EUCTR2017-001240-35-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 121 | NCT03196427 (ClinicalTrials.gov) | July 30, 2018 | 20/6/2017 | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc. | Active, not recruiting | 2 Years | 17 Years | All | 80 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 122 | EUCTR2017-000576-29-EE (EUCTR) | 25/07/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 123 | EUCTR2017-000617-23-HU (EUCTR) | 24/07/2018 | 15/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 124 | EUCTR2017-000576-29-HU (EUCTR) | 24/07/2018 | 15/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 125 | EUCTR2017-003359-43-HR (EUCTR) | 19/07/2018 | 16/05/2019 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease | Moderate To Severe Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 126 | EUCTR2017-003359-43-CZ (EUCTR) | 19/07/2018 | 04/06/2018 | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;United Arab Emirates;Serbia;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 127 | EUCTR2017-000617-23-ES (EUCTR) | 16/07/2018 | 14/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 128 | EUCTR2016-001367-36-IT (EUCTR) | 12/07/2018 | 15/06/2021 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn's Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn's Disease - NA | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 129 | EUCTR2017-000576-29-ES (EUCTR) | 11/07/2018 | 21/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | ||
| 130 | EUCTR2018-001546-33-GB (EUCTR) | 11/07/2018 | 14/05/2018 | The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease | IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0 | Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab | University Southampton Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 131 | EUCTR2017-000576-29-SK (EUCTR) | 10/07/2018 | 17/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Japan;Bulgaria;Belgium;Argentina;Canada;Mexico;Hungary;Switzerland;Colombia;Turkey;Ireland;Lebanon;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;United States | ||
| 132 | EUCTR2017-000617-23-SK (EUCTR) | 10/07/2018 | 17/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Serbia;United States;Estonia;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 133 | EUCTR2017-000617-23-AT (EUCTR) | 06/07/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 134 | EUCTR2017-000575-88-AT (EUCTR) | 06/07/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan | ||
| 135 | EUCTR2017-001240-35-LT (EUCTR) | 05/07/2018 | 23/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium | ||
| 136 | EUCTR2017-001225-41-DK (EUCTR) | 27/06/2018 | 07/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 137 | EUCTR2017-001226-18-DE (EUCTR) | 26/06/2018 | 09/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 138 | EUCTR2017-001240-35-DE (EUCTR) | 26/06/2018 | 28/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 139 | EUCTR2016-002763-34-IT (EUCTR) | 26/06/2018 | 15/06/2021 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn's Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease - NA | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 140 | EUCTR2017-001225-41-DE (EUCTR) | 26/06/2018 | 08/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 141 | EUCTR2017-003359-43-SK (EUCTR) | 26/06/2018 | 19/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 142 | EUCTR2017-001240-35-DK (EUCTR) | 25/06/2018 | 10/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 143 | NCT03559517 (ClinicalTrials.gov) | June 25, 2018 | 9/5/2018 | Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305) | Crohn's Disease | Biological: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 30 | Phase 3 | United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom |
| 144 | EUCTR2017-003359-43-HU (EUCTR) | 21/06/2018 | 25/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50mg Product Code: PF-06651600 50mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 145 | EUCTR2017-000575-88-LT (EUCTR) | 15/06/2018 | 20/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | ||
| 146 | EUCTR2017-000617-23-LT (EUCTR) | 15/06/2018 | 20/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 147 | EUCTR2017-001240-35-EE (EUCTR) | 14/06/2018 | 07/05/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Ireland;Israel;Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 148 | EUCTR2017-001226-18-EE (EUCTR) | 14/06/2018 | 07/05/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 149 | NCT03566823 (ClinicalTrials.gov) | June 11, 2018 | 9/5/2018 | Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306) | Crohn's Disease | Biological: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 34 | Phase 3 | New Zealand;Portugal;Slovakia;Spain;Turkey;Ukraine;United States;Mexico;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon |
| 150 | EUCTR2017-001226-18-LT (EUCTR) | 06/06/2018 | 23/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 151 | EUCTR2017-001225-41-LT (EUCTR) | 06/06/2018 | 23/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 152 | EUCTR2017-003359-43-IT (EUCTR) | 05/06/2018 | 21/01/2021 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease - nd | Moderate To Severe Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg Product Code: [PF-06651600 50 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg Product Code: [PF-06700841 5 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg Product Code: [PF-06700841 25 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czech Republic;Hungary;Slovakia;Belgium;Spain;Poland;Croatia;Lithuania;Austria;Germany;Italy | ||
| 153 | EUCTR2017-003359-43-BE (EUCTR) | 28/05/2018 | 06/03/2019 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 154 | EUCTR2017-001226-18-DK (EUCTR) | 28/05/2018 | 16/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 155 | EUCTR2017-003359-43-LT (EUCTR) | 24/05/2018 | 17/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 255 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 156 | EUCTR2017-003359-43-PL (EUCTR) | 23/05/2018 | 24/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 157 | EUCTR2017-001226-18-LV (EUCTR) | 21/05/2018 | 07/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 158 | EUCTR2017-001225-41-NL (EUCTR) | 18/05/2018 | 08/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 159 | EUCTR2017-001225-41-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 160 | EUCTR2017-001240-35-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 161 | EUCTR2017-001240-35-NL (EUCTR) | 18/05/2018 | 08/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 162 | EUCTR2017-001226-18-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 163 | EUCTR2017-003649-10-GB (EUCTR) | 15/05/2018 | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 164 | EUCTR2017-001225-41-PT (EUCTR) | 14/05/2018 | 19/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of;China;Latvia;Netherlands;South Africa;Australia;Denmark;Malaysia;Puerto Rico;Switzerland;Italy;Colombia;Russian Federation;Chile;Israel;Ireland;Ukraine;Spain;Slovakia;Taiwan;Hong Kong;United States;Serbia;Portugal | ||
| 165 | EUCTR2017-001240-35-PT (EUCTR) | 14/05/2018 | 01/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 166 | EUCTR2017-001226-18-PT (EUCTR) | 14/05/2018 | 01/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 625 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 167 | EUCTR2017-001240-35-PL (EUCTR) | 10/05/2018 | 09/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 168 | EUCTR2017-001226-18-PL (EUCTR) | 10/05/2018 | 12/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 169 | EUCTR2017-001225-41-ES (EUCTR) | 10/05/2018 | 10/05/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 170 | EUCTR2017-001240-35-ES (EUCTR) | 10/05/2018 | 10/05/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 171 | EUCTR2017-001226-18-ES (EUCTR) | 09/05/2018 | 10/05/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 172 | EUCTR2017-003649-10-BE (EUCTR) | 02/05/2018 | 27/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 173 | EUCTR2017-003649-10-DE (EUCTR) | 30/04/2018 | 07/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 174 | EUCTR2017-003359-43-ES (EUCTR) | 25/04/2018 | 27/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand | ||
| 175 | EUCTR2016-000522-18-CZ (EUCTR) | 24/04/2018 | 25/04/2018 | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 176 | EUCTR2017-001240-35-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 177 | EUCTR2017-001226-18-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | South Africa;Latvia;China;Bosnia and Herzegovina;Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 178 | EUCTR2017-001225-41-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 179 | EUCTR2017-001226-18-IT (EUCTR) | 12/04/2018 | 15/06/2021 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Slovenia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 180 | EUCTR2017-001240-35-IT (EUCTR) | 12/04/2018 | 15/06/2021 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional e/o Biologiche Therapies. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies. - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 181 | EUCTR2017-001225-41-IT (EUCTR) | 05/04/2018 | 17/06/2021 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadaticitib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 182 | JPRN-UMIN000031839 | 2018/04/01 | 01/04/2018 | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients | Crohn's disease | At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week. | Osaka University Graduate School of MedicineDepartment of Gastroenterology and Hepatology | Japan Community Health care Organizationi Osaka Hospital, Gastroenterology and HepatologyNational Hospital Organization Osaka National Hospital, Gastroenterology and HepatologyOsaka Rosai Hospital , Gastroenterology and HepatologyKansai Rosai Hospital, Gastroenterology and HepatologyItami City Hospital, Gastroenterology and HepatologyHyogo Prefectural Nishinomiya Hospital, Gastroenterology and HepatologyNishinomiya Municipal central hospital, Gastroenterology and Hepatology | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not selected | Japan |
| 183 | EUCTR2017-001240-35-LV (EUCTR) | 28/03/2018 | 07/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 184 | EUCTR2017-001225-41-GB (EUCTR) | 27/03/2018 | 15/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 185 | EUCTR2017-001240-35-GB (EUCTR) | 26/03/2018 | 06/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 186 | EUCTR2017-001226-18-GB (EUCTR) | 26/03/2018 | 06/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 187 | EUCTR2017-001225-41-SE (EUCTR) | 15/03/2018 | 12/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 188 | EUCTR2017-001240-35-SE (EUCTR) | 15/03/2018 | 15/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 189 | EUCTR2017-001226-18-SE (EUCTR) | 12/03/2018 | 16/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 190 | EUCTR2017-001226-18-AT (EUCTR) | 12/03/2018 | 28/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 191 | EUCTR2017-001240-35-AT (EUCTR) | 12/03/2018 | 28/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 192 | EUCTR2017-001225-41-LV (EUCTR) | 09/03/2018 | 14/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 193 | NCT03801928 (ClinicalTrials.gov) | February 23, 2018 | 11/12/2018 | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Drug: Inflectra | Pfizer | NULL | Completed | 18 Years | N/A | All | 118 | United States;Canada | |
| 194 | EUCTR2017-001225-41-AT (EUCTR) | 19/02/2018 | 07/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 195 | EUCTR2017-000725-12-IT (EUCTR) | 08/01/2018 | 09/11/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. - - | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: [Cx601] | TIGENIX S.A.U | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 196 | EUCTR2017-000725-12-FR (EUCTR) | 16/11/2017 | 25/11/2019 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 197 | NCT03138655 (ClinicalTrials.gov) | November 8, 2017 | 19/4/2017 | Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd. | Completed | 2 Years | 17 Years | All | 90 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 198 | EUCTR2016-001367-36-NL (EUCTR) | 06/11/2017 | 14/08/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 199 | EUCTR2016-002763-34-NL (EUCTR) | 06/11/2017 | 14/08/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 200 | NCT03171246 (ClinicalTrials.gov) | October 23, 2017 | 17/5/2017 | CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease | An Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's Disease | Crohn Disease | Dietary Supplement: Solid food-based intervention | NHS Greater Glasgow and Clyde | University of Glasgow | Unknown status | 6 Years | 65 Years | All | 20 | N/A | United Kingdom |
| 201 | EUCTR2014-005376-29-HU (EUCTR) | 13/10/2017 | 30/08/2017 | An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's disease | An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 202 | NCT03279081 (ClinicalTrials.gov) | September 15, 2017 | 21/7/2017 | Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) | A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks | Crohn's Disease | Drug: Cx601;Other: Placebo | Tigenix S.A.U. | NULL | Recruiting | 18 Years | N/A | All | 554 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;Sweden;United Kingdom |
| 203 | EUCTR2017-000725-12-BE (EUCTR) | 12/09/2017 | 01/06/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 204 | EUCTR2017-000725-12-HU (EUCTR) | 07/09/2017 | 10/07/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 205 | EUCTR2017-000725-12-PL (EUCTR) | 03/09/2017 | 28/07/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | ||
| 206 | EUCTR2017-000725-12-CZ (EUCTR) | 08/08/2017 | 26/04/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 207 | EUCTR2015-000852-12-BE (EUCTR) | 31/07/2017 | 24/03/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 18.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 4 | France;United States;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 208 | EUCTR2017-000725-12-ES (EUCTR) | 26/07/2017 | 06/06/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). | A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study. | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue Product Code: Cx601 INN or Proposed INN: To be determined Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 209 | NCT03219359 (ClinicalTrials.gov) | July 12, 2017 | 13/7/2017 | Autologous Stem Cell Transplant for Crohn's Disease | Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD) | Crohn Disease | Procedure: Autologous stem cell transplant;Drug: Cyclophosphamide;Drug: Thymoglobulin;Drug: Methylprednisolone;Drug: Vedolizumab | Icahn School of Medicine at Mount Sinai | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 210 | EUCTR2016-001367-36-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 211 | EUCTR2016-002763-34-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 212 | JPRN-jRCTs041180126 | 17/06/2017 | 23/03/2019 | CD Alfacalcidol study | The study of effect of Alfacalcidol treatment on Crohn's disease | Crohn's disease | administration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level. | Nakamura Masanao | NULL | Recruiting | >= 18age old | Not applicable | Both | 36 | Phase 2 | Japan |
| 213 | NCT02764762 (ClinicalTrials.gov) | June 12, 2017 | 5/5/2016 | Triple Combination Therapy in High Risk Crohn's Disease (CD) | An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications | Crohn Disease | Drug: Vedolizumab;Drug: Adalimumab;Drug: Methotrexate | Takeda | NULL | Active, not recruiting | 18 Years | 65 Years | All | 55 | Phase 4 | United States;Canada |
| 214 | NCT03393247 (ClinicalTrials.gov) | June 1, 2017 | 8/7/2017 | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study | Crohn Disease | Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14 | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Unknown status | 14 Years | 60 Years | All | 160 | N/A | China |
| 215 | EUCTR2016-001367-36-NO (EUCTR) | 31/05/2017 | 09/11/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Iceland;New Zealand;Japan;Sweden | ||
| 216 | EUCTR2016-001367-36-SE (EUCTR) | 24/05/2017 | 27/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland | ||
| 217 | EUCTR2016-002763-34-SE (EUCTR) | 24/05/2017 | 27/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 218 | EUCTR2016-002763-34-IS (EUCTR) | 09/05/2017 | 27/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 219 | EUCTR2016-001367-36-IS (EUCTR) | 09/05/2017 | 27/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of | ||
| 220 | EUCTR2016-002763-34-GR (EUCTR) | 05/05/2017 | 03/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 221 | EUCTR2016-002763-34-BE (EUCTR) | 31/03/2017 | 08/08/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 222 | EUCTR2016-001367-36-GR (EUCTR) | 31/03/2017 | 03/01/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 223 | EUCTR2016-001367-36-BE (EUCTR) | 31/03/2017 | 08/08/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 224 | NCT03090139 (ClinicalTrials.gov) | March 28, 2017 | 22/3/2017 | Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets | Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE) | Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel Diseases | Drug: Anti-TNF Therapy | Takeda | NULL | Completed | 18 Years | N/A | All | 1731 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
| 225 | EUCTR2016-002763-34-DE (EUCTR) | 27/03/2017 | 27/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 226 | EUCTR2016-001367-36-DE (EUCTR) | 27/03/2017 | 27/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;Japan;New Zealand;Sweden;Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia | ||
| 227 | EUCTR2016-001367-36-BG (EUCTR) | 23/03/2017 | 12/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden | ||
| 228 | EUCTR2016-002763-34-BG (EUCTR) | 23/03/2017 | 12/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 229 | EUCTR2016-001367-36-PT (EUCTR) | 13/03/2017 | 05/01/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Belarus;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 230 | EUCTR2016-002763-34-PT (EUCTR) | 13/03/2017 | 05/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 231 | JPRN-UMIN000026330 | 2017/02/27 | 28/02/2017 | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients | Crohn disease | Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) | University of Toyama | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 232 | EUCTR2016-002763-34-SK (EUCTR) | 16/02/2017 | 12/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 233 | EUCTR2016-001367-36-SK (EUCTR) | 16/02/2017 | 12/01/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden | ||
| 234 | EUCTR2016-001367-36-HU (EUCTR) | 08/02/2017 | 08/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 235 | EUCTR2016-002763-34-CZ (EUCTR) | 08/02/2017 | 16/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 236 | EUCTR2016-001367-36-CZ (EUCTR) | 08/02/2017 | 16/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 237 | EUCTR2016-002763-34-HU (EUCTR) | 08/02/2017 | 08/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden;Austria;Czechia;Korea, Republic of;Netherlands;South Africa;Australia;Malaysia;France;India;Switzerland;Italy;Sri Lanka;Israel;Russian Federation;Ireland;Ukraine;Spain;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Serbia;United States | ||
| 238 | EUCTR2016-001367-36-ES (EUCTR) | 31/01/2017 | 01/02/2017 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 239 | EUCTR2016-001367-36-AT (EUCTR) | 31/01/2017 | 15/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 240 | EUCTR2016-002763-34-ES (EUCTR) | 31/01/2017 | 30/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 241 | EUCTR2016-002763-34-AT (EUCTR) | 31/01/2017 | 15/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 242 | EUCTR2016-000522-18-DE (EUCTR) | 05/01/2017 | 01/08/2016 | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Product Name: Methotrexat INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBD-Net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 3 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 243 | EUCTR2016-001367-36-GB (EUCTR) | 04/01/2017 | 19/12/2016 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn’s Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 244 | EUCTR2016-002763-34-GB (EUCTR) | 04/01/2017 | 21/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 245 | NCT02231814 (ClinicalTrials.gov) | December 2016 | 27/8/2014 | The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease | Dietary Therapy Using the Crohn's Disease Exclusion Diet (CDED) With Partial Enteral Nutrition or Alone for Induction and Maintenance of Remission in in Adults With Mild to Moderate Crohn's Disease- A Pilot Study | Crohn's Disease | Dietary Supplement: Crohns Disease Exclusion Diet + PEN;Other: Crohns Disease Exclusion Diet | Prof. Arie Levine | NULL | Completed | 18 Years | 55 Years | All | 40 | N/A | Israel |
| 246 | NCT03183661 (ClinicalTrials.gov) | November 16, 2016 | 8/6/2017 | A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial | Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101) | Crohn Disease | Biological: ALLO-ASC-CD | Anterogen Co., Ltd. | NULL | Enrolling by invitation | 18 Years | 65 Years | All | 9 | N/A | NULL |
| 247 | EUCTR2015-000852-12-NL (EUCTR) | 05/10/2016 | 30/05/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 248 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 249 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 250 | NCT02820493 (ClinicalTrials.gov) | September 2016 | 17/5/2016 | Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF | Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression | Crohn Disease | Drug: vedolizumab | Universita degli Studi di Genova | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 4 | NULL |
| 251 | EUCTR2015-000852-12-ES (EUCTR) | 20/07/2016 | 20/07/2016 | NCT02630966 | TITLE A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE | Fistulizing Crohn?s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 252 | EUCTR2015-000852-12-FR (EUCTR) | 13/07/2016 | 15/03/2019 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 253 | EUCTR2015-000852-12-GB (EUCTR) | 07/07/2016 | 30/03/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 254 | NCT02793778 (ClinicalTrials.gov) | July 2016 | 1/6/2016 | Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy | Crohn's Disease | Drug: CROWN;Drug: CROWN Placebo | Prometheus Laboratories | Nestlé Health Science Spain;Nestec Ltd. | Terminated | 18 Years | 85 Years | All | 42 | Phase 2 | United States |
| 255 | NCT02782663 (ClinicalTrials.gov) | May 18, 2016 | 23/5/2016 | A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease | Crohn's Disease (CD) | Drug: ABT-494 | AbbVie | NULL | Active, not recruiting | 18 Years | 75 Years | All | 210 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom |
| 256 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 257 | EUCTR2015-003270-32-IT (EUCTR) | 09/02/2016 | 20/03/2019 | Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease | Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab | Ulcerative colitis (UC) and Crohn disease (CD) MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: entyvio INN or Proposed INN: VEDOLIZUMAB | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Italy | ||
| 258 | EUCTR2015-001693-18-IT (EUCTR) | 29/01/2016 | 07/03/2018 | - | A Phase 2, Open-Label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects with Active Crohn's Disease - GED-0301-CD-005 | Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 259 | NCT02611817 (ClinicalTrials.gov) | January 4, 2016 | 19/11/2015 | Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD) | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Drug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mg | Takeda | NULL | Completed | 18 Years | 80 Years | All | 644 | Phase 3 | United States;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic;Spain |
| 260 | NCT02532738 (ClinicalTrials.gov) | January 2016 | 23/8/2015 | The Efficiency of MSC in Refractory Crohn's Disease | A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease | Crohn's Disease | Drug: Routine Treatment of CD;Biological: MSC treatment 01;Biological: MSC treatment 02;Other: NS | Sixth Affiliated Hospital, Sun Yat-sen University | Third Affiliated Hospital, Sun Yat-Sen University;Nanfang Hospital of Southern Medical University | Not yet recruiting | 18 Years | 65 Years | Both | 3 | Phase 2/Phase 3 | NULL |
| 261 | NCT02926300 (ClinicalTrials.gov) | November 2015 | 11/11/2015 | Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/2 | Korea, Republic of |
| 262 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 263 | NCT02646683 (ClinicalTrials.gov) | July 2015 | 27/8/2015 | A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study | An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study (LOw Countries VEdolizumab in CD Study) | Crohn Disease | Drug: vedolizumab | Geert D'Haens | Takeda | Recruiting | 18 Years | 80 Years | All | 260 | Phase 4 | Belgium;Hungary;Netherlands |
| 264 | EUCTR2014-005376-29-NL (EUCTR) | 29/06/2015 | 08/01/2015 | An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease. | An open-label observational phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Netherlands | ||
| 265 | EUCTR2014-005376-29-BE (EUCTR) | 02/06/2015 | 03/02/2015 | An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease. | An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Belgium;Netherlands | ||
| 266 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 267 | NCT02580617 (ClinicalTrials.gov) | April 2015 | 15/10/2015 | A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease | A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease | Crohn's Disease | Biological: ALLO-ASC | Anterogen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 1 | Korea, Republic of |
| 268 | NCT03306446 (ClinicalTrials.gov) | March 17, 2015 | 21/6/2015 | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | CD | Drug: Start adalimumab in monotherapy | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Active, not recruiting | 18 Years | 75 Years | All | 203 | Phase 4 | Belgium;France |
| 269 | JPRN-UMIN000032485 | 2015/01/01 | 08/05/2018 | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study | Cron's disease | adalimumab azathiopurine | Sakura medical center, Toho university | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 20 | Not selected | Japan |
| 270 | NCT02426567 (ClinicalTrials.gov) | November 2014 | 17/4/2015 | The Impact of Crohn's Disease-TReatment-with-EATing Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria | An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity | Crohn's Disease;Dietary Modification | Other: Exclusive Enteral Nutrition (EEN);Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet) | University of Glasgow | NULL | Completed | 18 Years | N/A | Both | 28 | N/A | United Kingdom |
| 271 | JPRN-UMIN000015770 | 2014/09/01 | 01/12/2014 | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. | Crohn's disease (180 <= CDAI < 450)CDAI: Crohn's disease Activity Index | Standard therapy for Crohn's disease (Pentasa 3 g/day) Patients take curcumin or placebo | Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 30 | Not selected | Japan |
| 272 | NCT02000362 (ClinicalTrials.gov) | August 2014 | 7/11/2013 | Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: Stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/Phase 2 | Korea, Republic of |
| 273 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 274 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 275 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 276 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 277 | NCT02108821 (ClinicalTrials.gov) | March 2014 | 21/3/2014 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh;Stanford University | Completed | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
| 278 | NCT01765439 (ClinicalTrials.gov) | February 2014 | 7/1/2013 | The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Dietary Supplement: VSL#3 (Original De Simone formulation) | Charles University, Czech Republic | Iscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La Sapienza | Active, not recruiting | N/A | N/A | All | 79 | N/A | Czechia;Czech Republic |
| 279 | NCT01817972 (ClinicalTrials.gov) | March 2013 | 19/3/2013 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Certolizumab pegol;Drug: Azathioprine | Gastroenterology Research of America | UCB Pharma | Not yet recruiting | 18 Years | 70 Years | Both | 65 | Phase 3 | United States |
| 280 | EUCTR2012-002030-37-BE (EUCTR) | 08/01/2013 | 05/09/2012 | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 281 | NCT01757964 (ClinicalTrials.gov) | December 2012 | 22/12/2012 | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CD | Biological: Bacteriotherapy | David Suskind | Seattle Children's Hospital | Completed | 12 Years | 21 Years | All | 13 | Phase 1 | United States |
| 282 | NCT01349920 (ClinicalTrials.gov) | November 28, 2012 | 5/5/2011 | Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143) | An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD) | Crohn Disease | Drug: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 60 Years | All | 15 | Moldova, Republic of;United Kingdom | |
| 283 | NCT01823042 (ClinicalTrials.gov) | October 2012 | 25/3/2013 | The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD) | A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD). | Crohn's Disease | Drug: azathioprine+enteral nutrition;Drug: Azathioprine | Jinling Hospital, China | NULL | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China |
| 284 | EUCTR2011-006064-43-DE (EUCTR) | 27/09/2012 | 17/02/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease. | A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s disease MedDRA version: 17.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix S.A.U. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 285 | EUCTR2011-006064-43-IT (EUCTR) | 13/09/2012 | 05/03/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study | Perianal fistulising Crohn's disease MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601 Product Code: Cx601 INN or Proposed INN: NA Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs) | CELLERIX S.A. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy | ||
| 286 | EUCTR2011-002517-11-BG (EUCTR) | 18/07/2012 | 27/06/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | France;Serbia;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany | ||
| 287 | EUCTR2011-006064-43-NL (EUCTR) | 03/07/2012 | 05/07/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease. | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study | Perianal fistulising Crohn´s disease MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million/ml suspension for injection. Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A. Unipersonal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy | ||
| 288 | NCT01629628 (ClinicalTrials.gov) | July 2012 | 19/6/2012 | Adalimumab for the Management of Post-operative Crohn's Disease (CD) | An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients | Crohn Disease | Drug: Adalimumab;Drug: 6 Mercaptopurine | Tel-Aviv Sourasky Medical Center | Abbott | Not yet recruiting | 18 Years | 70 Years | Both | 100 | Phase 3 | Israel |
| 289 | NCT00692939 (ClinicalTrials.gov) | June 26, 2012 | 3/6/2008 | Autologous Stem Cell Transplantation for Crohn's Disease | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease | Crohn's Disease | Biological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: Mesna | Paul Szabolcs | NULL | Recruiting | 10 Years | 60 Years | All | 20 | Phase 1/Phase 2 | United States |
| 290 | EUCTR2011-006064-43-BE (EUCTR) | 22/06/2012 | 21/02/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease. | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s desease MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million/ml suspension for injection. Product Code: Cx601 INN or Proposed INN: N/A Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A. Unipersonal | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy | ||
| 291 | EUCTR2011-006064-43-AT (EUCTR) | 15/05/2012 | 05/03/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn’s disease. | A phase III, randomised, double blind, parallel group, placebo controlled,multicentre study to assess efficacy and safety of expanded allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s disease MedDRA version: 19.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 292 | EUCTR2011-002517-11-CZ (EUCTR) | 23/04/2012 | 25/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Hungary;Czech Republic;Germany | |||
| 293 | EUCTR2010-023589-39-DE (EUCTR) | 10/04/2012 | 16/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 294 | NCT01877577 (ClinicalTrials.gov) | April 2012 | 11/6/2013 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 295 | EUCTR2011-002517-11-HU (EUCTR) | 26/03/2012 | 09/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany | |||
| 296 | JPRN-UMIN000013534 | 2012/03/01 | 28/03/2014 | The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease | Crohn's disease | 1.To collect approximately 20ml of peripheral blood from CD patients who are under medical examination and treatment in Hyogo College of Medicine. 2.To be provided approximately 30g of intestinal specimen from the patients with CD who undergoes intestinal resection in Hyogo College of Medicine. | Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine | Sanwa Kagaku Kenkyusho Co,, Ltd. | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 297 | EUCTR2011-002517-11-DE (EUCTR) | 22/02/2012 | 02/11/2011 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany | |||
| 298 | NCT01514240 (ClinicalTrials.gov) | February 2012 | 10/1/2012 | Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Drug: D9421-C capsule 3 mg;Drug: Mesalazine tablets | AstraZeneca | NULL | Completed | 15 Years | 130 Years | All | 123 | Phase 3 | Japan |
| 299 | EUCTR2011-003966-34-ES (EUCTR) | 10/01/2012 | 13/10/2011 | Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Spain | |||
| 300 | EUCTR2008-005237-30-SE (EUCTR) | 14/12/2011 | 16/08/2011 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP | Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden | |||
| 301 | EUCTR2011-003966-34-BE (EUCTR) | 06/12/2011 | 11/10/2011 | Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn’s disease treated with immunosuppressants | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Spain;Belgium | ||
| 302 | EUCTR2010-018431-18-CZ (EUCTR) | 08/08/2011 | 19/05/2011 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 303 | EUCTR2010-023589-39-GB (EUCTR) | 02/08/2011 | 19/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Austria;Germany;United Kingdom | ||
| 304 | EUCTR2010-018431-18-HU (EUCTR) | 14/07/2011 | 13/05/2011 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Netherlands;Germany;New Zealand;Denmark;Australia;Belgium;Poland;Czech Republic;Hungary;France;Italy;United Kingdom;Israel;Austria | |||
| 305 | JPRN-UMIN000005946 | 2011/07/01 | 07/07/2011 | Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD | Crohn's disease | Endoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients with CD. | Fukuoka University Chikushi Hospital | NULL | Complete: follow-up continuing | 15years-old | 75years-old | Male and Female | 100 | Not selected | Japan | |
| 306 | EUCTR2010-023589-39-AT (EUCTR) | 22/06/2011 | 17/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 307 | JPRN-UMIN000005251 | 2011/06/01 | 01/06/2011 | A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab | Crohn's disease | Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly. | Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 14 | Not selected | Japan | |
| 308 | EUCTR2010-018431-18-BE (EUCTR) | 19/11/2010 | 28/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 309 | NCT01190839 (ClinicalTrials.gov) | November 2010 | 12/8/2010 | A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence | Crohn's Disease | Biological: Infliximab;Drug: Placebo | Janssen Biotech, Inc. | NULL | Terminated | 18 Years | 99 Years | All | 297 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain |
| 310 | EUCTR2010-018431-18-NL (EUCTR) | 28/10/2010 | 20/09/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 311 | EUCTR2010-018431-18-FR (EUCTR) | 15/09/2010 | 09/07/2010 | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 3 | France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 312 | EUCTR2010-018431-18-DE (EUCTR) | 23/08/2010 | 24/06/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | |||
| 313 | EUCTR2010-018431-18-GB (EUCTR) | 16/08/2010 | 06/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | ||
| 314 | EUCTR2010-018431-18-AT (EUCTR) | 06/08/2010 | 05/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | |||
| 315 | EUCTR2009-015680-14-NL (EUCTR) | 18/05/2010 | 27/07/2010 | Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | single or multiple draining perianal fistulas as a result of Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs) Product Code: NA | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 316 | EUCTR2009-011621-14-DE (EUCTR) | 12/05/2010 | 26/01/2010 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria | |||
| 317 | EUCTR2008-005237-30-NL (EUCTR) | 01/12/2009 | 18/08/2009 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP | Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | |||
| 318 | EUCTR2009-011621-14-AT (EUCTR) | 12/11/2009 | 19/10/2009 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: Not available Other descriptive name: None | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria | |||
| 319 | EUCTR2009-011220-62-NL (EUCTR) | 26/10/2009 | 13/07/2009 | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: mesalazine INN or Proposed INN: mesalazine Other descriptive name: AMINOSALICYLIC ACID | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 320 | EUCTR2008-008359-40-DE (EUCTR) | 08/09/2009 | 23/06/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202 | Moderate to severe Crohn's disease (CDAI >/= 220 and MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Poland;Austria | |||
| 321 | EUCTR2008-008359-40-PL (EUCTR) | 02/09/2009 | 07/04/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 Other descriptive name: rhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria;Poland | |||
| 322 | NCT01012570 (ClinicalTrials.gov) | August 2009 | 11/11/2009 | The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients | Crohn's Disease | Drug: Application of Adalimumab | Gerhard Rogler | NULL | Terminated | 18 Years | 65 Years | Both | 34 | Switzerland | ||
| 323 | EUCTR2008-008359-40-AT (EUCTR) | 07/05/2009 | 31/03/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Poland;Austria | |||
| 324 | EUCTR2008-004276-49-FR (EUCTR) | 18/12/2008 | 21/07/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | France;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 325 | EUCTR2007-002716-26-EE (EUCTR) | 17/12/2008 | 11/12/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 326 | NCT00805766 (ClinicalTrials.gov) | December 2008 | 9/12/2008 | Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD) | Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD) | Crohn's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 16 Years | 75 Years | All | 39 | Phase 3 | Japan |
| 327 | EUCTR2008-003571-45-IT (EUCTR) | 18/11/2008 | 22/09/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND | CP-690,550 is being developed for the treatment of patients with moderate-to-severe Crohn?s disease, as defined by a baseline Crohn?s Disease Activity Index (CDAI) score of 220 to 450 inclusive. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Code: CP-690,550 Product Name: CP-690,550 Product Code: CP-690,550 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 328 | EUCTR2008-004276-49-GB (EUCTR) | 12/11/2008 | 27/01/2009 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 329 | EUCTR2006-003371-13-CZ (EUCTR) | 29/10/2008 | 11/05/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 330 | EUCTR2008-004276-49-NL (EUCTR) | 14/10/2008 | 05/08/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||
| 331 | EUCTR2008-004276-49-BE (EUCTR) | 07/10/2008 | 15/09/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Netherlands;United Kingdom;Italy | ||
| 332 | EUCTR2007-001913-41-AT (EUCTR) | 10/09/2008 | 18/06/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 333 | EUCTR2007-001913-41-DE (EUCTR) | 27/08/2008 | 20/03/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 334 | EUCTR2007-002716-26-AT (EUCTR) | 08/08/2008 | 18/06/2008 | Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Australia;Latvia;Germany;New Zealand | ||
| 335 | NCT00707512 (ClinicalTrials.gov) | June 2008 | 27/6/2008 | CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | Crohn's Disease | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | N/A | Both | 87 | N/A | United States;Puerto Rico |
| 336 | EUCTR2007-001913-41-CZ (EUCTR) | 14/04/2008 | 07/04/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 337 | EUCTR2007-002716-26-CZ (EUCTR) | 07/04/2008 | 07/04/2008 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Estonia;Hungary;Czech Republic;Finland;Belgium;Austria;Latvia;Italy | ||
| 338 | EUCTR2006-003371-13-IE (EUCTR) | 03/04/2008 | 05/02/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 339 | EUCTR2007-002716-26-IT (EUCTR) | 04/03/2008 | 12/02/2008 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND | Crohn?s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 340 | EUCTR2007-001913-41-IT (EUCTR) | 04/03/2008 | 12/02/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND | Crohn?s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celletech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 341 | NCT00552058 (ClinicalTrials.gov) | March 2008 | 18/10/2007 | Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease | Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease. | Crohn Disease | Biological: certolizumab pegol (CDP870, CZP);Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | 75 Years | All | 439 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Czechia;Estonia;Finland;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Spain |
| 342 | EUCTR2006-003371-13-PL (EUCTR) | 27/02/2008 | 30/11/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02. | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02. | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 343 | EUCTR2007-001913-41-EE (EUCTR) | 11/02/2008 | 11/12/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 344 | EUCTR2007-003239-21-FR (EUCTR) | 05/02/2008 | 15/01/2008 | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol (rINN) Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate | UCB PHARMA S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | France | |||
| 345 | EUCTR2007-001913-41-BE (EUCTR) | 23/01/2008 | 13/11/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 346 | EUCTR2007-002716-26-BE (EUCTR) | 22/01/2008 | 16/10/2007 | Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Romania;Australia;Latvia;Germany;New Zealand | ||
| 347 | EUCTR2007-001913-41-LV (EUCTR) | 20/12/2007 | 05/11/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 348 | EUCTR2007-002716-26-LV (EUCTR) | 20/12/2007 | 05/11/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Czech Republic;Estonia;Hungary;Finland;Belgium;Austria;Latvia;Italy | ||
| 349 | EUCTR2007-001913-41-HU (EUCTR) | 18/12/2007 | 31/10/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 350 | EUCTR2007-002716-26-HU (EUCTR) | 18/12/2007 | 31/10/2007 | Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Australia;Latvia;Germany;New Zealand;United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania | ||
| 351 | EUCTR2007-001913-41-FI (EUCTR) | 12/12/2007 | 16/10/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 352 | EUCTR2007-002716-26-FI (EUCTR) | 12/12/2007 | 16/10/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 353 | EUCTR2005-003827-38-AT (EUCTR) | 15/10/2007 | 15/10/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 354 | EUCTR2005-003827-38-FR (EUCTR) | 20/09/2007 | 23/07/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Bulgaria;France;Austria;Sweden | |||
| 355 | EUCTR2005-003827-38-SE (EUCTR) | 19/09/2007 | 11/07/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 356 | EUCTR2005-003827-38-BE (EUCTR) | 19/09/2007 | 26/07/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Denmark;Belgium;France;Bulgaria;Austria;Sweden | |||
| 357 | EUCTR2006-003371-13-GB (EUCTR) | 16/08/2007 | 22/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 358 | EUCTR2006-003371-13-DE (EUCTR) | 17/07/2007 | 14/12/2006 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 359 | EUCTR2006-001729-24-ES (EUCTR) | 01/06/2007 | 01/06/2007 | Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Patients suffering from Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 360 | EUCTR2006-003371-13-NL (EUCTR) | 22/05/2007 | 19/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006) | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006) | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 361 | EUCTR2006-003371-13-FR (EUCTR) | 16/05/2007 | 29/12/2006 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 362 | EUCTR2006-001729-24-NL (EUCTR) | 10/05/2007 | 18/04/2007 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Sweden;Austria;Italy;Spain;France;Belgium;Netherlands;Germany;United Kingdom | |||
| 363 | EUCTR2006-001729-24-IT (EUCTR) | 10/05/2007 | 26/06/2007 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 | Patients suffering from Crohn's disease and having completed the C87042 study MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 | UCB PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 364 | EUCTR2006-001729-24-AT (EUCTR) | 09/05/2007 | 18/12/2006 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 365 | EUCTR2006-001729-24-SE (EUCTR) | 25/04/2007 | 09/03/2007 | Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 366 | EUCTR2005-003977-25-DE (EUCTR) | 13/04/2007 | 05/03/2007 | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Germany;Belgium | ||
| 367 | EUCTR2006-003371-13-DK (EUCTR) | 03/04/2007 | 09/03/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Ireland;Italy;Poland | ||
| 368 | EUCTR2006-003371-13-BE (EUCTR) | 03/04/2007 | 24/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 369 | EUCTR2005-003827-38-DE (EUCTR) | 15/03/2007 | 14/12/2006 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden | |||
| 370 | EUCTR2005-003827-38-HU (EUCTR) | 13/03/2007 | 22/12/2006 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 423 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 371 | EUCTR2005-003827-38-BG (EUCTR) | 09/03/2007 | 01/03/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 336 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 372 | EUCTR2006-003371-13-IT (EUCTR) | 09/03/2007 | 14/07/2008 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - ND | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - ND | Crohn's Disease, NOS MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: abatacept INN or Proposed INN: abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 373 | EUCTR2006-001729-24-FR (EUCTR) | 22/02/2007 | 22/01/2007 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 374 | EUCTR2006-001729-24-GB (EUCTR) | 14/02/2007 | 07/12/2006 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 375 | EUCTR2006-003871-11-DE (EUCTR) | 06/02/2007 | 26/10/2006 | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | Germany | |||
| 376 | EUCTR2005-003977-25-BE (EUCTR) | 31/01/2007 | 11/12/2006 | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Germany;Belgium | ||
| 377 | EUCTR2004-001213-34-GB (EUCTR) | 30/01/2007 | 19/08/2008 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | Trade Name: Salofalk INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicyl acid Trade Name: Budenofalk INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Czech Republic;United Kingdom | |||
| 378 | EUCTR2006-001729-24-DE (EUCTR) | 16/01/2007 | 20/11/2006 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol in patients suffering from Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 605 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 379 | EUCTR2006-002027-16-GR (EUCTR) | 12/12/2006 | 05/09/2006 | Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. | Certolizumab pegol 400 mg monthly in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. | Certolizumab pegol in the treatment of adult Greek patients with moderate to severe Crohn’s Disease, who have been previously treated successfully with infliximab but who have subsequently lost the response or have developed intolerance to infliximab | Product Name: certolizumab pegol Product Code: CDP870 | UCB AE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Greece | ||||
| 380 | NCT00406653 (ClinicalTrials.gov) | December 2006 | 1/12/2006 | A Study of Abatacept in Patients With Active Crohn's Disease | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy | Crohn's Disease | Drug: abatacept;Drug: placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 451 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;Argentina;Ireland;Korea, Republic of;Spain;United Kingdom |
| 381 | EUCTR2006-003870-88-DE (EUCTR) | 27/11/2006 | 29/09/2006 | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | Phase 3 | Germany | ||
| 382 | EUCTR2006-001729-24-BE (EUCTR) | 18/10/2006 | 01/09/2006 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 383 | NCT00333788 (ClinicalTrials.gov) | October 2006 | 2/6/2006 | Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease | Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study. | Crohn's Disease | Biological: Certolizumab pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 233 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 384 | EUCTR2005-004104-37-ES (EUCTR) | 28/07/2006 | 11/05/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Belgium;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 385 | NCT00287170 (ClinicalTrials.gov) | July 2006 | 2/2/2006 | Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease | Pilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD | Crohn's Disease | Drug: Delayed Release 6MP or Calcitriol vs. Purinethol | Teva GTC | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 1/Phase 2 | Israel |
| 386 | EUCTR2005-004104-37-DK (EUCTR) | 15/06/2006 | 04/05/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 387 | EUCTR2005-004104-37-SE (EUCTR) | 08/06/2006 | 21/04/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 388 | EUCTR2005-004104-37-AT (EUCTR) | 24/05/2006 | 04/04/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 389 | EUCTR2005-004104-37-DE (EUCTR) | 19/05/2006 | 29/03/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden | ||
| 390 | EUCTR2005-004104-37-GB (EUCTR) | 17/05/2006 | 17/03/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 391 | EUCTR2005-003827-38-GB (EUCTR) | 02/05/2006 | 18/11/2005 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 598 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden | ||
| 392 | NCT00329420 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668) | A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 16 Years | 64 Years | All | 46 | Phase 2 | Japan |
| 393 | NCT00329550 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease | A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol (CZP) | UCB Japan Co. Ltd. | NULL | Completed | 16 Years | 64 Years | All | 40 | Phase 2 | Japan |
| 394 | EUCTR2005-004104-37-BE (EUCTR) | 23/03/2006 | 27/01/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 395 | NCT00291668 (ClinicalTrials.gov) | March 2, 2006 | 10/2/2006 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn's Disease | Biological: Certolizumab Pegol;Other: Placebo | UCB Pharma | NULL | Completed | 16 Years | 65 Years | All | 94 | Phase 2 | Japan |
| 396 | EUCTR2005-003827-38-DK (EUCTR) | 27/02/2006 | 07/12/2005 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 598 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 397 | EUCTR2005-003827-38-CZ (EUCTR) | 20/02/2006 | 15/12/2005 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;United Kingdom;Czech Republic;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 398 | NCT00297648 (ClinicalTrials.gov) | February 2006 | 27/2/2006 | Mucosal Healing Study in Crohn's Disease (CD) | A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease. | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 89 | Phase 3 | Belgium;France;Germany |
| 399 | NCT00630643 (ClinicalTrials.gov) | January 2006 | 28/2/2008 | NI-0401 in Active Crohn's Disease | A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease | Moderate to Severe Crohn's Disease | Biological: NI-0401 (anti-CD3 mAB);Drug: Placebo | NovImmune SA | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 1/Phase 2 | NULL |
| 400 | NCT00132899 (ClinicalTrials.gov) | December 2005 | 19/8/2005 | COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial) | A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD) | Crohn's Disease | Drug: Methotrexate;Drug: Placebo | University of Western Ontario, Canada | Schering-Plough | Completed | 18 Years | N/A | Both | 128 | Phase 3 | Canada |
| 401 | EUCTR2004-004387-72-AT (EUCTR) | 11/10/2005 | 09/06/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Austria;Germany | ||
| 402 | EUCTR2004-004388-31-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD). MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 403 | EUCTR2004-004387-72-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 404 | NCT00271947 (ClinicalTrials.gov) | April 2005 | 2/1/2006 | Crohn's Disease Stem Cell Transplantation | Crohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy | Crohn's Disease | Biological: Autologous Stem Cell Transplantation | Northwestern University | NULL | Terminated | 18 Years | 55 Years | All | 1 | Phase 2 | United States |
| 405 | EUCTR2004-002693-37-DE (EUCTR) | 14/03/2005 | 06/01/2005 | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2 | A MULTICENTER, OPEN-LABEL, STUDY OF EXTRACORPOREAL PHOTOIMMUNE THERAPY WITH UVADEX IN THE TREATMENT OF PATIENTS WITH MODERATELY ACTIVE CROHN’S DISEASE WHO ARE REFRACTORY OR INTOLERANT TO IMMUNOSUPPRESSANTS AND/OR ANTI-TNF AGENTS - CD-2 | Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Trade Name: UVADEX INN or Proposed INN: methoxsalen | Therakos | NULL | Not Recruiting | Female: yes Male: yes | 25 | Germany | |||
| 406 | EUCTR2004-003839-31-DK (EUCTR) | 05/02/2005 | 17/05/2005 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | Crohn's Disease (CD) | Product Name: natalizumab Product Code: AN100226 INN or Proposed INN: natalizumab | Elan Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Denmark | ||
| 407 | EUCTR2004-001213-34-SK (EUCTR) | 16/12/2004 | 16/08/2005 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 3 | Czech Republic;Slovakia;United Kingdom | ||
| 408 | EUCTR2004-001213-34-CZ (EUCTR) | 02/11/2004 | 02/11/2004 | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | United Kingdom;Czech Republic | |||
| 409 | NCT00300118 (ClinicalTrials.gov) | September 2004 | 7/3/2006 | Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD) | Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients | Crohn's Disease | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 311 | Phase 3 | Germany |
| 410 | NCT00160524 (ClinicalTrials.gov) | July 2004 | 8/9/2005 | A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032 | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | NULL | Completed | 18 Years | N/A | All | 596 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Czech Republic;Tunisia |
| 411 | NCT00160706 (ClinicalTrials.gov) | February 2004 | 8/9/2005 | A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease. | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | NULL | Completed | 18 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine;Czech Republic |
| 412 | NCT00152425 (ClinicalTrials.gov) | February 2004 | 7/9/2005 | Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870). | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870 | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 392 | Phase 3 | NULL |
| 413 | NCT00088062 (ClinicalTrials.gov) | February 2004 | 19/7/2004 | STA-5326 in Crohn's Disease Patients | A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450 | Crohn's Disease | Drug: STA-5326 | Synta Pharmaceuticals Corp. | NULL | Completed | 18 Years | 65 Years | Both | 48 | Phase 1/Phase 2 | United States |
| 414 | NCT00152490 (ClinicalTrials.gov) | December 2003 | 8/9/2005 | A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo) | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 604 | Phase 3 | NULL |
| 415 | NCT00740103 (ClinicalTrials.gov) | December 2002 | 21/8/2008 | Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease | Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo | Crohn's Disease | Drug: Semapimod | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 119 | Phase 2 | United States;Belgium;Germany;Israel;Netherlands |
| 416 | EUCTR2020-004301-31-PL (EUCTR) | 01/12/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 417 | EUCTR2014-004400-30-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42) | A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 46 | Japan | ||||
| 418 | EUCTR2020-004301-31-BE (EUCTR) | 26/01/2022 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 419 | EUCTR2017-000575-88-CZ (EUCTR) | 25/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | |||
| 420 | EUCTR2017-000575-88-PL (EUCTR) | 20/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | |||
| 421 | EUCTR2017-003649-10-PL (EUCTR) | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Germany;Poland;Spain;Belgium;United States | |||
| 422 | EUCTR2010-023589-39-HU (EUCTR) | 26/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | ||||
| 423 | EUCTR2020-004301-31-CZ (EUCTR) | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 424 | EUCTR2017-000617-23-CZ (EUCTR) | 25/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | |||
| 425 | EUCTR2014-004399-42-Outside-EU/EEA (EUCTR) | 05/03/2015 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | Japan | |||
| 426 | EUCTR2014-004354-34-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease | A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 35 | Japan | ||||
| 427 | EUCTR2017-000617-23-IE (EUCTR) | 10/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;United Kingdom;Austria;Lithuania;Turkey;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Australia;Italy;Switzerland;Colombia;Israel;Russian Federation;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;Serbia;United States | |||
| 428 | EUCTR2017-000576-29-IE (EUCTR) | 10/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | |||
| 429 | EUCTR2014-004381-24-Outside-EU/EEA (EUCTR) | 02/03/2015 | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents | A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: Certolizumab Pegol | UCB Celltech | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | United States;Australia;Canada;New Zealand | |||
| 430 | EUCTR2017-000617-23-PL (EUCTR) | 20/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | |||
| 431 | JPRN-JapicCTI-121765 | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Intervention name : D9421-C Dosage And administration of the intervention : 9mg, Oral once daily Control intervention name : Mesalazine Dosage And administration of the control intervention : 1g, Oral three times a day | AstraZeneca | NULL | 15 | BOTH | Phase 3 | NULL |
97. Ulcerative colitis
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05239702 (ClinicalTrials.gov) | February 28, 2022 | 1/12/2021 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases | Crohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune Diseases | Biological: CD7 CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 2 | NCT04626947 (ClinicalTrials.gov) | October 30, 2021 | 29/9/2020 | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. Infections | Biological: Bezlotoxumab | David Binion, MD | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 3 | EUCTR2020-004461-40-IT (EUCTR) | 15/09/2021 | 18/10/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - | moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: [BMS-986165] INN or Proposed INN: deucravacitinib | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 4 | EUCTR2020-004461-40-DE (EUCTR) | 04/08/2021 | 12/05/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis | moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: BMS-986165 INN or Proposed INN: deucravacitinib Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States | ||
| 5 | NCT04996797 (ClinicalTrials.gov) | July 14, 2021 | 2/8/2021 | A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: PRA023 IV;Device: Companion Diagnostic (CDx) Testing;Other: Placebo | Prometheus Biosciences, Inc. | NULL | Recruiting | 18 Years | N/A | All | 170 | Phase 2 | United States |
| 6 | EUCTR2020-001398-59-BE (EUCTR) | 15/12/2020 | 13/10/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Serbia;Belarus;Hungary;Poland;Belgium;Ukraine;Lithuania;Croatia;Russian Federation;Georgia;Bulgaria;Latvia | ||
| 7 | EUCTR2020-001398-59-HR (EUCTR) | 02/12/2020 | 07/12/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 8 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 9 | EUCTR2020-001398-59-BG (EUCTR) | 13/10/2020 | 18/09/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: Lusvertikimab Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Belarus;Serbia;Spain;Ukraine;Russian Federation;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;South Africa;Latvia | ||
| 10 | EUCTR2020-001398-59-LV (EUCTR) | 21/09/2020 | 28/07/2020 | Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s) | Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s) | Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127 | OSE Immunotherapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia | ||
| 11 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 12 | EUCTR2018-005086-39-HU (EUCTR) | 28/10/2019 | 08/04/2019 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 13 | EUCTR2018-005086-39-PL (EUCTR) | 07/10/2019 | 06/05/2019 | A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 14 | EUCTR2017-004997-32-DE (EUCTR) | 25/06/2019 | 14/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 15 | EUCTR2017-004997-32-HU (EUCTR) | 04/02/2019 | 04/04/2019 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 16 | EUCTR2017-004997-32-NL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 17 | EUCTR2017-004997-32-IT (EUCTR) | 10/01/2019 | 18/06/2021 | Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) Product Code: [NA] | GENENTECH, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 18 | EUCTR2017-004997-32-GB (EUCTR) | 04/01/2019 | 09/10/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 19 | EUCTR2017-004997-32-IE (EUCTR) | 14/12/2018 | 13/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: efmarodocokin alfa INN or Proposed INN: efmarodocokin alfa Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 20 | EUCTR2017-004997-32-ES (EUCTR) | 10/12/2018 | 17/09/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 21 | NCT03452501 (ClinicalTrials.gov) | August 26, 2018 | 26/2/2018 | Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients | An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD | Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | NULL | Completed | 18 Years | N/A | All | 157 | Saudi Arabia | |
| 22 | NCT03196427 (ClinicalTrials.gov) | July 30, 2018 | 20/6/2017 | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc. | Active, not recruiting | 2 Years | 17 Years | All | 80 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 23 | EUCTR2018-001546-33-GB (EUCTR) | 11/07/2018 | 14/05/2018 | The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease | IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0 | Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab | University Southampton Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 24 | EUCTR2017-003649-10-GB (EUCTR) | 15/05/2018 | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 25 | EUCTR2017-003649-10-BE (EUCTR) | 02/05/2018 | 27/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 26 | EUCTR2017-003649-10-DE (EUCTR) | 30/04/2018 | 07/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 27 | NCT03801928 (ClinicalTrials.gov) | February 23, 2018 | 11/12/2018 | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Drug: Inflectra | Pfizer | NULL | Completed | 18 Years | N/A | All | 118 | United States;Canada | |
| 28 | NCT03138655 (ClinicalTrials.gov) | November 8, 2017 | 19/4/2017 | Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd. | Completed | 2 Years | 17 Years | All | 90 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 29 | NCT03090139 (ClinicalTrials.gov) | March 28, 2017 | 22/3/2017 | Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets | Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE) | Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel Diseases | Drug: Anti-TNF Therapy | Takeda | NULL | Completed | 18 Years | N/A | All | 1731 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
| 30 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 31 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 32 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 33 | EUCTR2015-003270-32-IT (EUCTR) | 09/02/2016 | 20/03/2019 | Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease | Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab | Ulcerative colitis (UC) and Crohn disease (CD) MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: entyvio INN or Proposed INN: VEDOLIZUMAB | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Italy | ||
| 34 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 35 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 36 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 37 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 38 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 39 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 40 | NCT02108821 (ClinicalTrials.gov) | March 2014 | 21/3/2014 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh;Stanford University | Completed | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
| 41 | NCT01765439 (ClinicalTrials.gov) | February 2014 | 7/1/2013 | The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Dietary Supplement: VSL#3 (Original De Simone formulation) | Charles University, Czech Republic | Iscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La Sapienza | Active, not recruiting | N/A | N/A | All | 79 | N/A | Czechia;Czech Republic |
| 42 | EUCTR2012-002030-37-BE (EUCTR) | 08/01/2013 | 05/09/2012 | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 43 | NCT01757964 (ClinicalTrials.gov) | December 2012 | 22/12/2012 | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CD | Biological: Bacteriotherapy | David Suskind | Seattle Children's Hospital | Completed | 12 Years | 21 Years | All | 13 | Phase 1 | United States |
| 44 | NCT01877577 (ClinicalTrials.gov) | April 2012 | 11/6/2013 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 45 | NCT01287195 (ClinicalTrials.gov) | April 7, 2011 | 28/1/2011 | Oral OKT3 for the Treatment of Active Ulcerative Colitis | Oral Anti-CD3 for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Oral OKT3;Drug: Omeprazole | Brigham and Women's Hospital | NULL | Completed | 18 Years | 65 Years | All | 6 | Phase 1/Phase 2 | United States |
| 46 | EUCTR2008-005237-30-NL (EUCTR) | 01/12/2009 | 18/08/2009 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP | Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | |||
| 47 | EUCTR2008-002784-14-IT (EUCTR) | 22/07/2009 | 17/03/2009 | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn?s Disease - ND | Patients with Ulcerative Colitis (UC) and Crohn?s Disease (CD) MedDRA version: 9.1;Level: LLT;Classification code 10045282 MedDRA version: 9.1;Level: PT;Classification code 10011401 | Product Name: Vedolizumab Product Code: MLN0002 | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 48 | EUCTR2005-003707-37-BE (EUCTR) | 25/05/2007 | 18/12/2006 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 49 | EUCTR2005-003707-37-AT (EUCTR) | 09/05/2007 | 03/01/2007 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | ||
| 50 | EUCTR2005-004105-28-FR (EUCTR) | 26/04/2007 | 23/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 51 | EUCTR2005-004105-28-GR (EUCTR) | 15/03/2007 | 15/02/2007 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 52 | EUCTR2005-003482-17-GB (EUCTR) | 26/02/2007 | 01/02/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 53 | EUCTR2005-003482-17-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | A Phase 2, Randomized, Double-blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ D | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | ||
| 54 | EUCTR2005-003481-42-GR (EUCTR) | 30/01/2007 | 24/11/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 55 | EUCTR2005-004105-28-DE (EUCTR) | 11/10/2006 | 10/04/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis - RESTORE™ S | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;United Kingdom;Germany;Netherlands;France;Ireland;Greece | |||
| 56 | EUCTR2005-004105-28-NL (EUCTR) | 28/09/2006 | 10/08/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 57 | EUCTR2005-004105-28-GB (EUCTR) | 20/06/2006 | 07/03/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | |||
| 58 | EUCTR2005-004105-28-IE (EUCTR) | 20/06/2006 | 10/02/2006 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Hungary;Greece;Ireland;Netherlands;Germany;United Kingdom | ||
| 59 | EUCTR2005-003481-42-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece | |||
| 60 | EUCTR2005-003482-17-ES (EUCTR) | 26/05/2006 | 15/03/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative ColitisEstudio fase 2, aleatorizado, doble ciego, multicéntrico, de exploración de dosis de Visilizumab en sujetos con colitis ulcerosa refractaria a esteróides intravenosos. | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Ireland;Spain;Italy;Greece | ||
| 61 | EUCTR2005-003481-42-SK (EUCTR) | 21/04/2006 | 25/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 62 | EUCTR2005-003481-42-HU (EUCTR) | 04/04/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece | |||
| 63 | EUCTR2005-003481-42-IE (EUCTR) | 04/04/2006 | 10/01/2006 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | ||
| 64 | EUCTR2005-002063-87-HU (EUCTR) | 04/04/2006 | 02/05/2007 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 65 | EUCTR2005-002063-87-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Czech Republic;Germany;Belgium | ||
| 66 | EUCTR2005-003481-42-DE (EUCTR) | 22/03/2006 | 29/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece | |||
| 67 | EUCTR2005-002063-87-SK (EUCTR) | 16/03/2006 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2;Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany | ||
| 68 | EUCTR2005-003482-17-IE (EUCTR) | 03/03/2006 | 10/01/2006 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0;Level: LLT;Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Greece;Spain;Ireland;Italy;United Kingdom | ||
| 69 | EUCTR2005-003481-42-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - RESTORE™ R | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 9.0;Level: LLT;Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece | |||
| 70 | EUCTR2005-002063-87-CZ (EUCTR) | 16/02/2006 | 28/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | PDL BioPharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 71 | EUCTR2005-002063-87-BE (EUCTR) | 09/02/2006 | 24/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Germany;Czech Republic;Belgium | ||
| 72 | EUCTR2005-003481-42-AT (EUCTR) | 04/01/2006 | 30/11/2005 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | |||
| 73 | EUCTR2005-002063-87-AT (EUCTR) | 28/12/2005 | 23/11/2005 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 INN or Proposed INN: visilizumab Other descriptive name: anti-CD3 monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Czech Republic;Belgium;Austria;Germany | ||
| 74 | EUCTR2017-003649-10-PL (EUCTR) | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Germany;Poland;Spain;Belgium;United States |
265. Lipodystrophy
Clinical trials : 116 / Drugs : 170 - (DrugBank : 61) / Drug target genes : 26 - Drug target pathways : 97
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00646984 (ClinicalTrials.gov) | January 2002 | 26/3/2008 | Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy | Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy. | HIV-Associated Lipodystrophy Syndrome | Drug: Standard continuous antiretroviral therapy;Drug: CD-4 guided therapy interruption;Drug: Viral load driven treatment interruption | Hospital Clinic of Barcelona | NULL | Completed | 18 Years | N/A | Both | 147 | Phase 4 | Spain |