Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis

• Conditions: Colitis, Ulcerative; MedDRA version: 16.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-022506-41-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-28
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 386

Inclusion 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:
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified