97. 潰瘍性大腸炎
[臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
81 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04624230
(ClinicalTrials.gov)
November 20, 202026/10/2020Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative ColitisOPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITISUlcerative ColitisDrug: tofacitinibPfizerNULLNot yet recruiting2 Years17 YearsAll120Phase 3NULL
2NCT04505410
(ClinicalTrials.gov)
November 18, 20205/8/2020A Fasting Mimicking Diet on Ulcerative Colitis Patients Undergoing Tofacitinib InductionA Randomized Control Study to Examine the Influence of a Fasting Mimicking Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Tofacitinib InductionUlcerative ColitisDrug: Tofacitinib;Other: Fast Mimicking DietUniversity of MiamiPfizerRecruiting18 YearsN/AAll76Phase 3United States
3EUCTR2020-004391-18-FR
(EUCTR)
28/10/202014/09/2020IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITISIMPACT 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-PicardieNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4France
4EUCTR2020-002695-12-NL
(EUCTR)
14/10/202002/09/2020Treatment of refractory pouchitis with tofacitinibTofacitinib 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 tabletsAmsterdam UMC, location AMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Netherlands
5NCT04424303
(ClinicalTrials.gov)
September 30, 20208/6/2020Tofacitinib in Adult Patients With Moderate to Severe Ulcerative ColitisEvaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst StudyUlcerative ColitisDrug: TofacitinibPfizerNULLNot yet recruiting18 YearsN/AAll280NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04338204
(ClinicalTrials.gov)
September 14, 20204/4/2020Observational Study To Assess The Effectiveness Of Tofacitinib In Ulcerative Colitis In Clinical Practice In SwedenObservational Study of Tofacitinib in Ulcerative Colitis in Sweden (ODEN)Ulcerative ColitisDrug: tofacitinibPfizerNULLRecruiting18 Years99 YearsAll120Sweden
7EUCTR2019-004652-11-SI
(EUCTR)
28/08/202031/08/2020A Study of Etrolizumab-Based Induction Therapy Combinations Followed by Etrolizumab Maintenance Therapy in Patients with Moderate-To-Severe Ulcerative ColitisRANDOMIZED, 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
372Phase 3Serbia;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
8NCT04576000
(ClinicalTrials.gov)
August 25, 202017/9/2020Identification of Biomarkers of Tofacitinib Therapy in Patients With Ulcerative ColitisPhaRmacOkinetics and PHarmacodynamic BiomarkErs of TofacItinib Therapy in Patients With Ulcerative Colitis (PROPHETIC)Ulcerative ColitisDrug: TofacitinibRobarts Clinical Trials Inc.NULLRecruiting18 YearsN/AAll100United States;Belgium;Canada;Italy;Netherlands;Spain
9EUCTR2019-003780-21-NL
(EUCTR)
04/05/202021/02/2020An investigation of tofacitinib in patients with ulcerative colitisPharmacokinetics and Pharmacodynamic Biomarkers of Tofacitinib 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: XELJANZ
INN or Proposed INN: TOFACITINIB
Robarts Clinical TrialsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4United States;Canada;Spain;Belgium;Netherlands;Italy
10EUCTR2018-004890-28-IT
(EUCTR)
09/10/201907/10/2020Study 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 VERGATANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03591770
(ClinicalTrials.gov)
July 31, 20199/7/2018Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on TofacitinibThe Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on TofacitinibInflammatory Bowel DiseasesBiological: SHINGRIXBoston Medical CenterNULLSuspended50 YearsN/AAll100Phase 4United States
12EUCTR2018-004587-61-NL
(EUCTR)
23/04/201913/05/2019Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximabDeep 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]Erasmus Medical CenterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 4Netherlands
13EUCTR2017-002274-39-NL
(EUCTR)
27/06/201819/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3;Phase 4United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
14EUCTR2017-002274-39-GB
(EUCTR)
12/04/201820/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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]
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3;Phase 4Serbia;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
15EUCTR2017-002274-39-BE
(EUCTR)
22/02/201818/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3;Phase 4United States;Poland;Serbia;South Africa;Czechia;Germany;Slovakia;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Netherlands;Japan;New Zealand;Korea, Republic of;Canada;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002274-39-CZ
(EUCTR)
16/01/201814/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3;Phase 4Serbia;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
17EUCTR2017-002274-39-AT
(EUCTR)
04/01/201820/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLNot RecruitingFemale: yes
Male: yes
130Phase 3Serbia;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
18EUCTR2017-002274-39-ES
(EUCTR)
21/12/201722/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3Serbia;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
19EUCTR2017-002274-39-HU
(EUCTR)
21/12/201719/12/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3;Phase 4United 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
20EUCTR2017-002274-39-SK
(EUCTR)
08/12/201727/10/2017A multi-center parallel group study of tofacitinib in subjects with ulcerative colitis in stable remissionA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3;Phase 4United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03281304
(ClinicalTrials.gov)
November 16, 201711/9/2017A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable RemissionA PHASE 3B/4,MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSIONUlcerative ColitisDrug: CP-690,500 5 mg;Drug: CP-690,550 10 mgPfizerNULLActive, not recruiting18 YearsN/AAll141Phase 4United States;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom
22EUCTR2016-002691-27-NL
(EUCTR)
19/10/201701/06/2017An 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 colitisAn 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 tabletsAcademic Medical CenterNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Netherlands
23NCT03103412
(ClinicalTrials.gov)
May 4, 201724/3/2017TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsDrug: TD-3504;Drug: 15N2-tofacitinib;Drug: PlaceboTheravance BiopharmaNULLCompleted18 Years55 YearsAll32Phase 1United States
24EUCTR2011-004579-35-HR
(EUCTR)
27/08/201328/08/2014A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
25EUCTR2011-004580-79-HR
(EUCTR)
26/08/201328/08/2014A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-004581-14-HR
(EUCTR)
26/08/201328/08/2014A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
725Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
27EUCTR2011-004578-27-HR
(EUCTR)
26/08/201328/08/2014A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
28EUCTR2011-004578-27-NL
(EUCTR)
04/03/201312/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada
29EUCTR2011-004578-27-IT
(EUCTR)
18/01/201307/08/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulverative colitis
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: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER INC.NULLNot RecruitingFemale: yes
Male: yes
545United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan
30EUCTR2011-004581-14-IT
(EUCTR)
18/01/201307/08/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
725United States;Estonia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;India;Hungary;Czech Republic;Canada;Brazil;Denmark;Australia;South Africa;Germany;Netherlands;Latvia;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-004580-79-IT
(EUCTR)
18/01/201307/08/2012maintenance therapy with CP-690,550 in subjects with ulcerative colitisA MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
PFIZER LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
654United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Croatia;Germany;New Zealand;Japan
32EUCTR2011-004579-35-NL
(EUCTR)
10/10/201212/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
33EUCTR2011-004581-14-NL
(EUCTR)
10/10/201212/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
34EUCTR2011-004578-27-PL
(EUCTR)
18/09/201220/06/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
35EUCTR2011-004581-14-PL
(EUCTR)
17/09/201222/06/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc., 235 East 42nd Street, New York, New York 10017, United StatesNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2011-004579-35-PL
(EUCTR)
17/09/201228/06/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand
37EUCTR2011-004580-79-PL
(EUCTR)
05/08/201212/06/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan
38EUCTR2011-004578-27-ES
(EUCTR)
11/07/201209/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
39EUCTR2011-004579-35-ES
(EUCTR)
11/07/201209/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
40EUCTR2011-004578-27-CZ
(EUCTR)
29/06/201208/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc,NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2011-004579-35-CZ
(EUCTR)
29/06/201208/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc,NULLNot RecruitingFemale: yes
Male: yes
545Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
42EUCTR2011-004581-14-CZ
(EUCTR)
29/06/201208/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;New Zealand
43EUCTR2011-004580-79-CZ
(EUCTR)
26/06/201208/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer IncNULLNot RecruitingFemale: yes
Male: yes
654Phase 3India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy
44EUCTR2011-004580-79-BE
(EUCTR)
08/06/201207/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
45EUCTR2011-004579-35-BE
(EUCTR)
08/06/201208/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2011-004581-14-BE
(EUCTR)
07/06/201207/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
47EUCTR2011-004580-79-DE
(EUCTR)
06/06/201228/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
654Phase 3Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia
48EUCTR2011-004578-27-BE
(EUCTR)
06/06/201207/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
49NCT01458951
(ClinicalTrials.gov)
June 201221/10/2011A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative ColitisA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.Ulcerative ColitisDrug: tofacitinib;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll547Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom
50EUCTR2011-004578-27-HU
(EUCTR)
30/05/201210/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2011-004579-35-DE
(EUCTR)
29/05/201221/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
52EUCTR2011-004581-14-LV
(EUCTR)
23/05/201201/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
725Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
53EUCTR2011-004580-79-LV
(EUCTR)
23/05/201201/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
54EUCTR2011-004578-27-DE
(EUCTR)
23/05/201205/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not availble
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USANULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
55EUCTR2011-004578-27-LV
(EUCTR)
23/05/201201/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2011-004579-35-LV
(EUCTR)
23/05/201201/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
57EUCTR2011-004580-79-ES
(EUCTR)
18/05/201209/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
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 Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States
58EUCTR2011-004581-14-ES
(EUCTR)
18/05/201214/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
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: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
725United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
59EUCTR2011-004580-79-AT
(EUCTR)
18/05/201227/03/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
60EUCTR2011-004581-14-AT
(EUCTR)
18/05/201227/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-004578-27-AT
(EUCTR)
18/05/201227/03/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
62EUCTR2011-004579-35-AT
(EUCTR)
18/05/201221/03/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
63EUCTR2011-004580-79-HU
(EUCTR)
10/05/201210/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
64EUCTR2011-004581-14-HU
(EUCTR)
10/05/201210/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
65EUCTR2011-004579-35-HU
(EUCTR)
10/05/201210/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2011-004580-79-SK
(EUCTR)
03/05/201210/04/2013A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
67EUCTR2011-004581-14-SK
(EUCTR)
02/05/201213/04/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Estonia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;New Zealand
68EUCTR2011-004578-27-SK
(EUCTR)
02/05/201212/04/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
69EUCTR2011-004579-35-SK
(EUCTR)
02/05/201213/04/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
70EUCTR2011-004581-14-GB
(EUCTR)
01/05/201201/03/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-004579-35-GB
(EUCTR)
01/05/201212/01/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
72EUCTR2011-004580-79-EE
(EUCTR)
26/04/201213/02/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan
73EUCTR2011-004581-14-EE
(EUCTR)
26/04/201213/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
74EUCTR2011-004578-27-GB
(EUCTR)
26/04/201212/01/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
75EUCTR2011-004579-35-EE
(EUCTR)
26/04/201214/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2011-004578-27-EE
(EUCTR)
26/04/201214/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
77NCT01465763
(ClinicalTrials.gov)
April 201221/10/2011A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative ColitisA Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative ColitisUlcerative ColitisDrug: tofacitinib;Drug: PlaceboPfizerNULLCompleted18 YearsN/AAll614Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil
78EUCTR2011-004581-14-DK
(EUCTR)
20/03/201209/02/2012A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitisA MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP-690,550-10
INN or Proposed INN: tofacitinib
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
900Phase 3Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand
79EUCTR2011-004579-35-DK
(EUCTR)
24/02/201224/02/2012A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Moderate to severe active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand
80EUCTR2011-004578-27-DK
(EUCTR)
24/02/201209/02/2012A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: CP-690,550-10
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
545Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2011-004580-79-DK
(EUCTR)
24/02/201223/01/2012A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: CP-690,550-10
Other descriptive name: tofacitinib
Pfizer Inc, 235 East 42nd Street, New York, New York 10017NULLNot RecruitingFemale: yes
Male: yes
654Phase 3Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan