Biologics ( DrugBank: - )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 70 |
| 96 | クローン病 | 19 |
| 97 | 潰瘍性大腸炎 | 56 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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-UMIN000043547 | 2021/03/08 | 08/03/2021 | Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. | Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. - Examination of structural remission and reduction of drug free of filgotinib in rheumatoid arthritis patients whose MTX alone or MTX combined with biologics are non responsive. | Rheumatoid Arthritis | 60 weeks Oral administration of 200mg filgotinib daily | DeparShinshu University School of Medicine | NULL | Recruiting | 20years-old | 100years-old | Male and Female | 100 | Not selected | Japan |
| 2 | NCT04255134 (ClinicalTrials.gov) | September 7, 2020 | 14/11/2019 | Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) | Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial | Rheumatoid Arthritis | Drug: Abatacept Injection;Drug: Adalimumab Injection | St George's, University of London | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 4 | United Kingdom |
| 3 | EUCTR2019-004468-23-GB (EUCTR) | 10/02/2020 | 26/02/2020 | Biologics for RA Pain ( BIORA-PAIN) | Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Abatacept Product Name: Abatacept INN or Proposed INN: Abatacept Trade Name: Humira Product Name: Humira INN or Proposed INN: Humira | St George's, University of London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | United Kingdom | ||
| 4 | NCT03737708 (ClinicalTrials.gov) | February 13, 2019 | 8/11/2018 | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) | Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial | Rheumatoid Arthritis (RA) | Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept | Astellas Pharma Korea, Inc. | NULL | Completed | 19 Years | 75 Years | All | 21 | Phase 4 | Korea, Republic of |
| 5 | NCT03755466 (ClinicalTrials.gov) | November 21, 2018 | 21/11/2018 | Examination of Efficacy and Safety of Baricitinib in RA Patients | Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib | Rheumatoid Arthritis | Drug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz] | Shinshu University | NULL | Recruiting | 20 Years | N/A | All | 90 | Phase 2 | Japan |
| 6 | NCT03535402 (ClinicalTrials.gov) | June 1, 2018 | 9/5/2018 | Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics | Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score. | Rheumatoid Arthritis | Drug: Sarilumab | Gaylis, Norman B., M.D. | NULL | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 7 | NCT03016884 (ClinicalTrials.gov) | January 2017 | 1/1/2017 | Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients | Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation | Herpes Zoster | Biological: Zostavax vaccine | HaEmek Medical Center, Israel | NULL | Active, not recruiting | 50 Years | N/A | All | 87 | Phase 4 | Israel |
| 8 | NCT02960490 (ClinicalTrials.gov) | November 26, 2016 | 3/11/2016 | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics | Rheumatoid Arthritis | Drug: E6011;Drug: Placebo | Eisai Co., Ltd. | NULL | Completed | 18 Years | 75 Years | All | 64 | Phase 2 | Japan |
| 9 | NCT02797769 (ClinicalTrials.gov) | June 2, 2016 | 8/6/2016 | A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA) | Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases | Rheumatoid Arthritis | Drug: Other Biologics;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 48950 | NULL | |
| 10 | EUCTR2015-002809-12-BG (EUCTR) | 27/01/2016 | 02/12/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | 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: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India | ||
| 11 | EUCTR2015-002809-12-ES (EUCTR) | 23/12/2015 | 30/10/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 12 | EUCTR2015-002809-12-CZ (EUCTR) | 27/11/2015 | 02/10/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | 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: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 13 | EUCTR2015-002809-12-HU (EUCTR) | 17/11/2015 | 26/08/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | 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: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India | ||
| 14 | EUCTR2015-002809-12-LV (EUCTR) | 17/11/2015 | 21/09/2015 | A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: YLB113 Product Code: YLB113 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel Product Name: Enbrel Product Code: Enbrel INN or Proposed INN: ETANERCEPT | YL Biologics Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India | ||
| 15 | JPRN-UMIN000018848 | 2015/11/01 | 29/08/2015 | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis | Rheumatoid arthritis | control: continue the present treatment intervention: reduce the dosage of methotrexate by half every 3 months and discontinue intervention: extend the interval of biologics to one and a half times every 3 months and discontinue | Keio University Hospital | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 900 | Not applicable | Japan |
| 16 | EUCTR2014-000110-61-DE (EUCTR) | 15/10/2015 | 04/05/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | 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] - Immune System Diseases [C20] | Product Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 17 | NCT02605642 (ClinicalTrials.gov) | September 10, 2015 | 2/9/2015 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade | PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB) | Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: CT-P13 | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Completed | 18 Years | N/A | All | 351 | Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy | |
| 18 | EUCTR2014-000110-61-ES (EUCTR) | 06/07/2015 | 01/06/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis 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] - Immune System Diseases [C20] | Product Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 19 | NCT02405780 (ClinicalTrials.gov) | June 10, 2015 | 17/3/2015 | A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 645 | Phase 3 | United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic |
| 20 | EUCTR2014-000110-61-CZ (EUCTR) | 11/05/2015 | 04/05/2015 | Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE | Rheumatoid Arthritis 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 Code: FKB327 PFS INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Code: FKB327 AI INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru | ||
| 21 | NCT02620189 (ClinicalTrials.gov) | March 2015 | 12/10/2015 | Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa | A Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa Therapies | Rheumatoid Arthritis | Drug: Anti-TNF Biologics Therapy | Queen Mary University of London | NULL | Completed | 18 Years | N/A | All | 60 | United Kingdom | |
| 22 | EUCTR2014-000109-11-DE (EUCTR) | 22/01/2015 | 08/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis 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 Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 730 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 23 | EUCTR2014-000109-11-BG (EUCTR) | 21/01/2015 | 10/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis 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 Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 730 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 24 | EUCTR2014-000109-11-CZ (EUCTR) | 18/12/2014 | 09/10/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC | Rheumatoid Arthritis 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 Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 25 | EUCTR2014-000109-11-ES (EUCTR) | 09/12/2014 | 04/11/2014 | Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis. | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. | Rheumatoid Arthritis 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 Code: FKB327 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany | ||
| 26 | NCT02260791 (ClinicalTrials.gov) | December 2014 | 29/7/2014 | A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients | A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate | Arthritis, Rheumatoid | Drug: FKB327;Drug: Humira® | Fujifilm Kyowa Kirin Biologics Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 728 | Phase 3 | United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia |
| 27 | EUCTR2013-002429-52-IE (EUCTR) | 23/10/2013 | 15/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | 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] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab SC Other descriptive name: TOCILIZUMAB SC | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 28 | EUCTR2013-002429-52-PT (EUCTR) | 21/10/2013 | 08/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 29 | NCT01995201 (ClinicalTrials.gov) | September 2013 | 1/11/2013 | A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis | A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | Both | 401 | Phase 3 | Ireland;Portugal;Spain |
| 30 | EUCTR2013-002429-52-ES (EUCTR) | 23/08/2013 | 12/07/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 31 | NCT01932372 (ClinicalTrials.gov) | July 26, 2013 | 30/7/2013 | Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis | XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE) | Rheumatoid Arthritis | Drug: Tofacitinib (Xeljanz);Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc | Pfizer | NULL | Completed | N/A | N/A | All | 9968 | Japan | |
| 32 | JPRN-UMIN000014485 | 2013/05/24 | 01/12/2014 | Golimumab study for development of tight control and biologics-free condition. | Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study | rheumatoid arthritis | Treatment with Golimumab for patients with rheumatoid arthritis | Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 33 | EUCTR2012-000609-58-CZ (EUCTR) | 22/05/2013 | 21/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | 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 Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 34 | EUCTR2012-000609-58-BE (EUCTR) | 20/02/2013 | 14/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | 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 Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany | ||
| 35 | EUCTR2012-000609-58-IT (EUCTR) | 07/01/2013 | 25/09/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics - NN8226-3612 | Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders 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: NA Product Code: 0109-0012A 100 mg/ml Product Name: NA Product Code: 0109-0012A 50 mg/ml Product Name: NA Product Code: 0109-0012A 25 mg/ml | NOVO NORDISK | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 36 | NCT01965132 (ClinicalTrials.gov) | January 1, 2013 | 11/10/2013 | Korean College of Rheumatology Biologics Registry | Korean College of Rheumatology Biologics Registry | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Biologic DMARD | Seoul National University Hospital | NULL | Recruiting | 18 Years | N/A | All | 7000 | Korea, Republic of | |
| 37 | JPRN-UMIN000013885 | 2012/12/01 | 05/05/2014 | Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study | Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study - Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study | rheumatoid arthiritis | RA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples. | Itabashi Chuo Medical Center | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 38 | EUCTR2012-000609-58-GB (EUCTR) | 01/11/2012 | 20/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | 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 Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany | ||
| 39 | EUCTR2012-000609-58-DE (EUCTR) | 25/09/2012 | 27/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | 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 Code: 0109-0012A 100 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 50 mg/ml INN or Proposed INN: N/A Product Code: 0109-0012A 25 mg/ml INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 40 | EUCTR2012-000609-58-HU (EUCTR) | 13/08/2012 | 18/06/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics | 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 Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | ||
| 41 | NCT01636817 (ClinicalTrials.gov) | August 2012 | 6/7/2012 | A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics | Inflammation;Rheumatoid Arthritis | Drug: NNC0109-0012;Drug: placebo | Novo Nordisk A/S | NULL | Terminated | 18 Years | 75 Years | All | 239 | Phase 2 | United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic |
| 42 | 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 | 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 - An intensive treatment strategy in patients with active early RA | 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 |
| 43 | NCT01646385 (ClinicalTrials.gov) | February 2012 | 12/4/2012 | Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry | Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data | Rheumatoid Arthritis | Drug: etanercept;Drug: non-biologic anti-rheumatic drugs | Pfizer | NULL | Completed | 18 Years | N/A | All | 6393 | N/A | NULL |
| 44 | NCT02922192 (ClinicalTrials.gov) | January 1, 2012 | 28/9/2016 | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis | Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis | Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics | Biologics & Biosimilars Collective Intelligence Consortium | HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Kaiser Permanente;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta Pharmaceuticals, Inc.;Pfizer;University of Pittsburgh | Completed | 18 Years | N/A | All | 90360 | NULL | |
| 45 | NCT01439204 (ClinicalTrials.gov) | October 2011 | 21/9/2011 | Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb | A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects | Rheumatoid Arthritis | Biological: Abatacept (BMS-188667) | Bristol-Myers Squibb | NULL | Completed | 18 Years | 55 Years | All | 223 | Phase 1 | United States |
| 46 | EUCTR2009-015019-42-DE (EUCTR) | 10/05/2011 | 20/08/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) 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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands | |||
| 47 | EUCTR2009-015019-42-BE (EUCTR) | 04/04/2011 | 06/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany | ||
| 48 | EUCTR2009-015019-42-FI (EUCTR) | 17/11/2010 | 27/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) 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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands | |||
| 49 | EUCTR2009-015019-42-LT (EUCTR) | 02/11/2010 | 17/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 50 | EUCTR2009-015019-42-AT (EUCTR) | 05/10/2010 | 01/09/2010 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 16.0;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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany | |||
| 51 | JPRN-UMIN000003880 | 2010/07/01 | 07/07/2010 | Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area | Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area - KABUKI study | Rheumatoid arthritis | DAS28>3.2 at 24 weeks Switching to another biologics DAS28>3.2 at 24 weeks Dose up of MTX or addition of other DMARDs DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every two week DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every four week | Osaka City University Medical School | Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 52 | JPRN-UMIN000003807 | 2010/07/01 | 01/07/2010 | A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis | A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis - JaSTAR Study | Rheumatoid Arthritis | Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate) Combination therapy of TNF-bloking biologics and methotrexate | Japan Association of Rheumatologists in Private Practice | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 160 | Not applicable | Japan |
| 53 | EUCTR2009-010582-23-BE (EUCTR) | 10/02/2010 | 23/09/2009 | Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 54 | EUCTR2009-010582-23-DE (EUCTR) | 04/01/2010 | 22/09/2009 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 55 | NCT00995449 (ClinicalTrials.gov) | January 2010 | 5/10/2009 | Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis | A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy | Rheumatoid Arthritis | Biological: KB003;Other: Placebo Comparator | KaloBios Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 9 | Phase 2 | United States |
| 56 | EUCTR2009-010582-23-GB (EUCTR) | 31/12/2009 | 28/06/2010 | Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab prefilled pen or prefilled syringe Product Code: CNTO 148 INN or Proposed INN: GOLIMUMAB Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 57 | EUCTR2008-006064-11-LT (EUCTR) | 30/12/2009 | 19/10/2009 | An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 564 | United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of | |||
| 58 | EUCTR2009-010582-23-SE (EUCTR) | 16/12/2009 | 23/10/2009 | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | Rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 59 | EUCTR2009-010582-23-AT (EUCTR) | 26/11/2009 | 12/10/2009 | Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®) | 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] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe Product Code: CNTO 148 INN or Proposed INN: golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden | ||
| 60 | EUCTR2009-011206-42-CZ (EUCTR) | 18/08/2009 | 05/06/2009 | A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics | A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics | Active Rheumatoid Arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt Product Name: INCB028050 phosphate Product Code: INCB028050 Other descriptive name: INCB028050 phosphate salt | Incyte Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Czech Republic | ||
| 61 | JPRN-UMIN000002340 | 2009/08/01 | 20/08/2009 | Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) | Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) - cHAMLET | Rheumatoid Arthritis | Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks | Department of Rheumatosurgery, Osaka City University Medical School | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Phase 4 | Japan |
| 62 | NCT00929357 (ClinicalTrials.gov) | August 2009 | 25/6/2009 | Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment | A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice. | Rheumatoid Arthritis | Drug: DMARDs or Biologics | Pfizer | NULL | Completed | 18 Years | N/A | All | 156 | N/A | Denmark |
| 63 | NCT00902486 (ClinicalTrials.gov) | May 2009 | 13/5/2009 | INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs | A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics | Rheumatoid Arthritis | Drug: INCB028050;Drug: Placebo | Incyte Corporation | NULL | Completed | 18 Years | N/A | All | 127 | Phase 2 | United States;Czechia;Czech Republic |
| 64 | NCT01081717 (ClinicalTrials.gov) | April 14, 2009 | 4/3/2010 | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database | A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments | Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis | Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population | Janssen Biotech, Inc. | NULL | Completed | N/A | 99 Years | All | 1064 | United States | |
| 65 | JPRN-UMIN000002421 | 2008/07/01 | 04/09/2009 | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis | rheumatoid arthritis | tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab | AA amyloidosis clinical research conference | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 66 | EUCTR2005-001742-16-DE (EUCTR) | 07/06/2006 | 23/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | United Kingdom;Germany;Netherlands;Spain;Austria | |||
| 67 | EUCTR2005-001742-16-FI (EUCTR) | 17/05/2006 | 04/04/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Finland;Spain;Austria;Germany;Netherlands;United Kingdom | |||
| 68 | EUCTR2005-001742-16-AT (EUCTR) | 01/05/2006 | 30/03/2006 | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - GO-AFTER | Active rheumatoid arthritis (RA) | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa Product Name: Golimumab Pre-Filled Syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Germany;United Kingdom;Netherlands;Spain;Austria | |||
| 69 | EUCTR2012-000609-58-ES (EUCTR) | 09/07/2012 | A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics | A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics | 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 Code: 0109-0012A 100 mg/ml Product Code: 0109-0012A 50 mg/ml Product Code: 0109-0012A 25 mg/ml | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 268 | Phase 2 | United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany | |||
| 70 | EUCTR2009-015019-42-Outside-EU/EEA (EUCTR) | 08/03/2012 | Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS) | A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS | Juvenile Idiopathic Arthritis (JIA) MedDRA version: 14.1;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: Golimumab Liquid in prefilled syringe Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 170 | Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | NCT05130983 (ClinicalTrials.gov) | January 23, 2023 | 16/11/2021 | Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's Disease | Crohn Disease;Inflammatory Bowel Diseases | Biological: ExoFlo | Direct Biologics, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | United States |
| 2 | NCT04859088 (ClinicalTrials.gov) | September 20, 2021 | 15/4/2021 | Biologics and Partial Enteral Nutrition Study | Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease | Crohn Disease | Dietary Supplement: Partial Enteral Nutrition | NHS Greater Glasgow and Clyde | University of Glasgow | Recruiting | 16 Years | N/A | All | 80 | N/A | United Kingdom |
| 3 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 4 | NCT03905109 (ClinicalTrials.gov) | April 15, 2020 | 3/4/2019 | Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease | A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment | Crohn Disease | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Belgium |
| 5 | NCT05542459 (ClinicalTrials.gov) | January 1, 2020 | 10/9/2022 | Multi-omics to Predict Responses to Biologics in IBD | Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Drug: Biologics | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 1050 | China | |
| 6 | NCT04131504 (ClinicalTrials.gov) | October 16, 2019 | 16/10/2019 | Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION) | A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF | Crohn's Disease;IBD | Drug: Infliximab;Drug: Adalimumab | Children's Hospital Medical Center, Cincinnati | The Leona M. and Harry B. Helmsley Charitable Trust | Active, not recruiting | 1 Year | 22 Years | All | 239 | United States | |
| 7 | NCT03472690 (ClinicalTrials.gov) | June 25, 2018 | 8/3/2018 | QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease | A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease | Crohn Disease | Biological: QBECO-SSI;Other: Placebo | Qu Biologics Inc. | NULL | Terminated | 18 Years | N/A | All | 20 | Phase 2 | Canada |
| 8 | NCT01809275 (ClinicalTrials.gov) | March 2013 | 8/3/2013 | Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease | A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Drug: QBECO;Drug: Placebo | Qu Biologics Inc. | NULL | Completed | 18 Years | N/A | Both | 68 | Phase 1/Phase 2 | Canada |
| 9 | 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 | |||
| 10 | 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 | |||
| 11 | 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 | Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 12 | 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 | |||
| 13 | 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 | Not Recruiting | Female: yes Male: yes | 290 | Phase 3 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Australia;Netherlands;Germany;New Zealand | ||
| 14 | 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 | |||
| 15 | 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 | ||
| 16 | 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 | |||
| 17 | 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 | |||
| 18 | EUCTR2008-006484-36-IT (EUCTR) | 16/04/2009 | 24/04/2009 | MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE | MULTICENTER COMPARATIVE STUDY BETWEEN NUTRITIONAL THERAPY ALONE ANDANTI-TNF-alpha MONOCLONAL ANTIBODY IN INDUCING AND MAINTAINING REMISSION INPEDIATRIC CROHN`S DISEASE: A RANDOMIZED CONTROLLED TRIAL - NUTRITION AND BIOLOGICS IN CROHN`S DISEASE | Moderate-to-severe active Crohn`sdisease. MedDRA version: 9.1;Level: LLT;Classification code 10011398;Term: Crohn's | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 19 | NCT00606346 (ClinicalTrials.gov) | May 31, 2007 | 21/1/2008 | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases | Biological: Anti TNF therapy including infliximab;Drug: No Biologics | Janssen Biotech, Inc. | NULL | Active, not recruiting | 1 Month | 17 Years | All | 4970 | United States;Canada |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 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 | NCT05771155 (ClinicalTrials.gov) | May 2023 | 1/3/2023 | Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio® | A Randomized, Double-blind, Multicenter Phase 3 Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) to Compare the Efficacy, Safety and Immunogenicity of PB016 and Entyvio® for the Induction and Maintenance of Clinical Response and Remission | Ulcerative Colitis | Biological: Intravenous (IV) infusions | Polpharma Biologics S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 750 | Phase 3 | NULL |
| 2 | NCT05176366 (ClinicalTrials.gov) | December 19, 2022 | 17/11/2021 | Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Biological: ExoFlo | Direct Biologics, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | United States |
| 3 | NCT05377580 (ClinicalTrials.gov) | July 1, 2022 | 6/5/2022 | A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI112 in Patients With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Placebo;Drug: IBI112 | Innovent Biologics (Suzhou) Co. Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | China |
| 4 | NCT05186623 (ClinicalTrials.gov) | February 5, 2022 | 22/12/2021 | Prediction Model for Response to Biologics and Small Molecular Agent for UC | Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data | Ulcerative Colitis | Drug: Vedolizumab, Ustekinumab, or Tofacitinib | Asan Medical Center | NULL | Recruiting | 18 Years | 79 Years | All | 300 | Korea, Republic of | |
| 5 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 6 | JPRN-jRCT1031200329 | 28/01/2021 | 28/01/2021 | UC Bio Study | Open-ravel randomized control trial to evaluate the efficacy of biologics for ulcerative colitis with treatment-refractoriness | Ulcerative colitis Biologics;D003093 | Infliximab:Infliximab (5 mg / kg / body weight) is infused intravenously at 0, 2, 6, 14, and 22 weeks. Vedolizumab:Intravenous infusion of vedolizumab 300 mg at 0, 2, 6, 14, and 22 weeks Ustekinumab: a single intravenous infusion of the dose shown below is given at the first induction therapy. Body weight dose 55kg or less 260mg 55-85kg 390mg 85kg or more 520mg After 8_weeks of intravenous drip infusion, 90 mg of ustekinumab is usually subcutaneously administered to adults, and 90 mg is subcutaneously administered at 12-week intervals thereafter. If the effect is diminished, the dosing interval can be shortened to 8 weeks. | Naganuma Makoto | NULL | Recruiting | >= 16age old | Not applicable | Both | 231 | N/A | Japan |
| 7 | NCT04241029 (ClinicalTrials.gov) | February 25, 2020 | 17/1/2020 | Boosting Biologics in UC | Boosting Biologics in Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Dietary Supplement: IDOFORM®Travel | Oslo University Hospital | Helse Sor-Ost | Recruiting | 18 Years | 75 Years | All | 20 | Phase 1 | Norway |
| 8 | NCT05542459 (ClinicalTrials.gov) | January 1, 2020 | 10/9/2022 | Multi-omics to Predict Responses to Biologics in IBD | Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Drug: Biologics | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 70 Years | All | 1050 | China | |
| 9 | EUCTR2017-004230-28-CZ (EUCTR) | 04/10/2019 | 11/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 10 | EUCTR2017-004496-31-NL (EUCTR) | 20/09/2019 | 27/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 11 | EUCTR2017-004230-28-HU (EUCTR) | 06/09/2019 | 08/07/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece | ||
| 12 | EUCTR2017-004230-28-GR (EUCTR) | 01/07/2019 | 03/05/2019 | BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;Norway;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany | ||
| 13 | EUCTR2017-004230-28-DK (EUCTR) | 14/06/2019 | 24/03/2019 | BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Denmark A/S | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 14 | EUCTR2017-004496-31-IT (EUCTR) | 18/02/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: SIMPONI Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: [CNTO312] INN or Proposed INN: INFLIXIMAB Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 15 | EUCTR2017-004496-31-PL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of | ||
| 16 | EUCTR2017-004496-31-FR (EUCTR) | 17/12/2018 | 14/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 17 | EUCTR2017-004496-31-BE (EUCTR) | 07/11/2018 | 25/07/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of | ||
| 18 | EUCTR2017-004496-31-ES (EUCTR) | 15/10/2018 | 28/08/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | 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] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 19 | EUCTR2017-004230-28-NL (EUCTR) | 30/08/2018 | 15/03/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of | ||
| 20 | EUCTR2017-004230-28-DE (EUCTR) | 04/06/2018 | 31/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 21 | EUCTR2017-004230-28-IT (EUCTR) | 22/05/2018 | 05/11/2020 | BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - - | Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands | ||
| 22 | EUCTR2017-004230-28-GB (EUCTR) | 13/04/2018 | 01/02/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 23 | EUCTR2017-004230-28-ES (EUCTR) | 09/04/2018 | 08/02/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of | ||
| 24 | NCT03482635 (ClinicalTrials.gov) | March 27, 2018 | 15/3/2018 | BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy | Colitis, Ulcerative | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 75 Years | All | 98 | Phase 2/Phase 3 | United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway |
| 25 | EUCTR2017-004230-28-BE (EUCTR) | 09/03/2018 | 22/01/2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;United Kingdom;Spain;Greece;Canada;Austria;Czech Republic;Netherlands;Belgium;China;Taiwan;Denmark;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Germany | ||
| 26 | EUCTR2017-004230-28-AT (EUCTR) | 27/02/2018 | 18/01/2018 | BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of | ||
| 27 | NCT02426372 (ClinicalTrials.gov) | July 2015 | 21/4/2015 | Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis | An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: QBECO SSI | Qu Biologics Inc. | NULL | Completed | 19 Years | N/A | All | 11 | Phase 2 | Canada |
| 28 | EUCTR2013-002042-36-FR (EUCTR) | 04/02/2015 | 22/06/2015 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;United States | ||
| 29 | EUCTR2013-002042-36-NL (EUCTR) | 24/09/2014 | 13/06/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany | ||
| 30 | EUCTR2013-002042-36-BG (EUCTR) | 11/09/2014 | 30/04/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 31 | EUCTR2013-002042-36-DE (EUCTR) | 31/07/2014 | 27/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 32 | EUCTR2013-002042-36-BE (EUCTR) | 10/07/2014 | 20/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 33 | EUCTR2013-002042-36-PL (EUCTR) | 09/06/2014 | 06/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands | ||
| 34 | EUCTR2013-002042-36-CZ (EUCTR) | 04/06/2014 | 21/03/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 35 | EUCTR2013-002042-36-HU (EUCTR) | 12/05/2014 | 21/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany | ||
| 36 | EUCTR2012-004366-18-BE (EUCTR) | 08/01/2014 | 27/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 37 | EUCTR2012-004366-18-DE (EUCTR) | 17/12/2013 | 29/07/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany | ||
| 38 | EUCTR2012-004366-18-DK (EUCTR) | 11/12/2013 | 03/12/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands | ||
| 39 | EUCTR2012-004366-18-NL (EUCTR) | 28/11/2013 | 16/08/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands | ||
| 40 | EUCTR2012-004366-18-AT (EUCTR) | 30/07/2013 | 12/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 41 | NCT01759056 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis | A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: AVX 470;Drug: Placebo | Avaxia Biologics, Incorporated | NULL | Completed | 18 Years | 75 Years | Both | 33 | Phase 1 | United States;Belgium;Canada;Hungary |
| 42 | EUCTR2006-003399-37-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 43 | 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 | |||
| 44 | EUCTR2006-003399-37-DK (EUCTR) | 25/09/2008 | 10/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 45 | EUCTR2006-003399-37-SE (EUCTR) | 26/08/2008 | 21/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 46 | EUCTR2006-003399-37-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 47 | EUCTR2006-003399-37-NL (EUCTR) | 17/01/2008 | 08/10/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 48 | EUCTR2006-003399-37-DE (EUCTR) | 27/11/2007 | 03/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 49 | EUCTR2006-003399-37-BE (EUCTR) | 15/11/2007 | 18/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 50 | EUCTR2006-003399-37-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden | ||
| 51 | EUCTR2006-003399-37-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 52 | EUCTR2006-003399-37-AT (EUCTR) | 27/09/2007 | 17/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 53 | EUCTR2006-003399-37-LV (EUCTR) | 03/09/2007 | 04/09/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan | ||
| 54 | NCT00606346 (ClinicalTrials.gov) | May 31, 2007 | 21/1/2008 | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases | Biological: Anti TNF therapy including infliximab;Drug: No Biologics | Janssen Biotech, Inc. | NULL | Active, not recruiting | 1 Month | 17 Years | All | 4970 | United States;Canada | |
| 55 | NCT00207688 (ClinicalTrials.gov) | August 31, 2004 | 13/9/2005 | A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients | A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Placebo | Janssen Research & Development, LLC | Janssen Biologics BV | Completed | N/A | N/A | All | 505 | New Zealand;Switzerland;United Kingdom;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;United States;Czech Republic | |
| 56 | EUCTR2012-004366-18-FR (EUCTR) | 28/09/2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany |