EUCTR2010-022506-41-IT
Active, not recruiting
Not Applicable
A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC) - Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 386
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence • Mayo score \`?¥6 with an endoscopic subscore of \`?¥2 • Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Diagnosis of Crohn\`??s Disease or Indeterminate Colitis • Diagnosis of UC that is limited to the rectum • Evidence of fulminant colitis, toxic megacolon, or bowel perforation • Current need for a colostomy or ileostomy • Previous total or subtotal colectomy
Outcomes
Primary Outcomes
Not specified
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