RBR-3q8j43RecruitingPhase 3
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
Hospital de Clínicas de Porto Alegre (Centro Coordenador)0 sitesStarted: February 17, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Intervention
Eligibility Criteria
- Ages
- 18Y to — (—)
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.
Investigators
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