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A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active 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.

NCT01458951•Pfizer

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must be at least 18 years of age.
•Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
•Subjects with moderately to severely active UC based on Mayo score criteria.
•Subjects must have failed or be intolerant of at least one of the following treatments for UC:
•* Corticosteroids (oral or intravenous).
•* Azathioprine or 6 mercaptopurine (6 MP).
•* Anti TNF therapy.

Exclusion Criteria

•Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
•Subjects with disease limited to distal 15 cm.
•Subjects without previous treatment for UC (ie, treatment naïve).
•Subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Locations (182)

Desert Sun Clinical Research, LLC

Tucson, Arizona, United States

Desert Sun Gastroenterology

Tucson, Arizona, United States

Desert Sun Surgery Center

Tucson, Arizona, United States

Alliance Clinical Research

Oceanside, California, United States

Clinical Application Laboratories

San Diego, California, United States

San Diego Endoscopy Center

San Diego, California, United States

UCSF Endoscopy Unit at Mount Zion

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, United States

Bristol Hospital

Bristol, Connecticut, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

May 1, 2015

Completion Date

June 1, 2015

Last Updated

June 1, 2016

Enrollment

547

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

tofacitinib

DRUG

Placebo

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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