97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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 | EUCTR2018-002378-30-DE (EUCTR) | 14/04/2022 | 13/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 2 | EUCTR2018-002378-30-HU (EUCTR) | 01/03/2022 | 15/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 3 | EUCTR2018-002378-30-FI (EUCTR) | 22/12/2021 | 20/12/2021 | OPEN-LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan;Sweden | ||
| 4 | EUCTR2020-004391-18-FR (EUCTR) | 28/10/2020 | 14/09/2020 | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS | IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS - VASC-UC | ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra 100 mg Product Name: Inflectra 100 mg Trade Name: AMGEVITA Product Name: AMGEVITA Trade Name: Simponi Product Name: Simponi Trade Name: Entyvio 300 mg Product Name: Entyvio 300 mg Trade Name: XELJANZ Product Name: XELJANZ | CHU Amiens-Picardie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | France | ||
| 5 | EUCTR2020-002695-12-NL (EUCTR) | 14/10/2020 | 02/09/2020 | Treatment of refractory pouchitis with tofacitinib | Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach - TOFA-Pouchitis | Chronic, recurrent and/or antibiotic refractory pouchitis in patients with 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: Xeljanz 5mg film-coated tablets | Amsterdam UMC, location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Netherlands | ||
| 6 | EUCTR2019-004652-11-SI (EUCTR) | 28/08/2020 | 31/08/2020 | A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative Colitis | RANDOMIZED, OPEN-LABEL PHASE 3B STUDY OF ETROLIZUMAB BASED INDUCTION THERAPY COMBINATIONS FOLLOWED BY ETROLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS - Lantana | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: RO5490261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: INFLIXIMAB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Xeljanz INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Latvia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Germany | ||
| 7 | EUCTR2019-003780-21-NL (EUCTR) | 04/05/2020 | 21/02/2020 | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients With Ulcerative Colitis (PROPHETIC Study) | 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: XELJANZ Product Name: Janus kinase Inhibitor INN or Proposed INN: Janus kinase Inhibitor | Alimentiv Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 4 | United States;Canada;Spain;Belgium;Netherlands;Italy | ||
| 8 | EUCTR2018-004890-28-IT (EUCTR) | 09/10/2019 | 07/10/2020 | Study for the research of predictive factors of response to Tofacitinib therapy in patients with ulcerative rectal colitis. | (A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study). - AVATAR | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Product Name: Xeljanz Product Code: [N/A] | DIP. MEDICINA DEI SISTEMI UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Italy | ||
| 9 | EUCTR2018-004587-61-NL (EUCTR) | 23/04/2019 | 13/05/2019 | Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab | Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: TOFACITINIB Trade Name: Inflectra Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Erasmus Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 10 | EUCTR2017-002274-39-NL (EUCTR) | 27/06/2018 | 19/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 11 | EUCTR2017-002274-39-GB (EUCTR) | 12/04/2018 | 20/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yes | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 12 | EUCTR2017-002274-39-BE (EUCTR) | 22/02/2018 | 18/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 13 | EUCTR2017-002274-39-IT (EUCTR) | 20/02/2018 | 12/02/2021 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLELGROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION - NA | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | PFIZER INC | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 14 | EUCTR2017-002274-39-CZ (EUCTR) | 16/01/2018 | 14/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 15 | EUCTR2017-002274-39-AT (EUCTR) | 04/01/2018 | 20/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 16 | EUCTR2017-002274-39-ES (EUCTR) | 21/12/2017 | 22/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 17 | EUCTR2017-002274-39-HU (EUCTR) | 21/12/2017 | 19/12/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 18 | EUCTR2017-002274-39-SK (EUCTR) | 08/12/2017 | 27/10/2017 | A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remission | A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: CP-690,550 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3;Phase 4 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 19 | EUCTR2016-002691-27-NL (EUCTR) | 19/10/2017 | 01/06/2017 | An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitis | An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histo | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz 5 mg film-coated tablets | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Netherlands | ||
| 20 | EUCTR2018-002378-30-SE (EUCTR) | 10/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan;Sweden | |||
| 21 | EUCTR2018-002378-30-PL (EUCTR) | 24/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan;Sweden | |||
| 22 | EUCTR2018-002378-30-IT (EUCTR) | 27/01/2022 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS - - | MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: XELJANZ - Product Name: Tofacitinib citrate Product Code: [CP-690, 550-10] INN or Proposed INN: tofacitinib citrate Trade Name: Xeljanz Product Name: Tofacitinib citrate Product Code: [CP-690, 550-10] INN or Proposed INN: tofacitinib | PFIZER INC | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 23 | EUCTR2018-002378-30-BE (EUCTR) | 13/12/2021 | OPEN LABEL MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | |||
| 24 | EUCTR2018-002378-30-SK (EUCTR) | 14/12/2021 | OPEN LABEL, MAINTENANCE STUDY OF ORAL TOFACITINIB IN CHILDREN WITH MODERATE TO SEVERE ULCERATIVE COLITIS | OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | MODERATELY TO SEVERELY ACTIVE 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: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: XELJANZ Product Name: Tofacitinib citrate Product Code: CP-690,550-10 INN or Proposed INN: TOFACITINIB Other descriptive name: TOFACITINIB CITRATE | Pfizer Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Finland;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden |