Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | March 2011 |
| End Date: | March 2015 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
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)
The purpose of this study is to determine whether BMS-936557 is effective in the treatment
of moderate to severely active ulcerative colitis in patients who have had insufficient
response and/or intolerance to other medical therapy for ulcerative colitis
of moderate to severely active ulcerative colitis in patients who have had insufficient
response and/or intolerance to other medical therapy for ulcerative colitis
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)
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
We found this trial at
22
sites
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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