A study to evaluate both the efficacy and safety profile of CP 690,550 in patients with moderately to severely active ulcerative colitis

Phase 3

Recruiting

• Conditions: lcerative Colitis; C06.405.205.265.231

• Registration Number: RBR-3q8j43
• Lead Sponsor: Hospital de Clínicas de Porto Alegre (Centro Coordenador)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Subject must be at least 18 years of age; males and females with a documented diagnosis of ulcerative colitis (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 ou intravenous), azathioprine or 6 mercaptopurine (6MP), anti TNF alpha therapy (infliximab ou
adalimumab).

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 naive); subjects displaying clinical signs of fulminant colitis or toxic megacolon.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome(1): The proportion of subjects in remission (improvement of ulcertative colitis) at Week 8. Remission (improvement of ulcerative colitis) is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.