A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Biological: MDX-1100; Biological: sterile saline for injection

• Registration Number: NCT00656890
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);

• Mayo score of 6 to 10 points with moderate to severe disease on endoscopy

• Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Read More

Exclusion Criteria

• Anti-TNF therapy within 8 weeks before study drug administration
• Contraindication to colonoscopy or sigmoidoscopy
• Primary or secondary immunodeficiency
• Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
• History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
• Evidence of acute or chronic infection
• Clinically significant disease requiring medication

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MDX-1100	MDX-1100 for injection
2	sterile saline for injection	sterile saline for injection

Primary Outcome Measures

Name	Time	Method
Change in Mayo score at Day 57 compared with Screening	Day 57

Secondary Outcome Measures

Name	Time	Method
the remission rate	Day 57

Trial Locations

Locations (7)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Florida Medical Clinic-Tampa Clinic; 🇺🇸 Tampa, Florida, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Advanced Medical Research Center; 🇺🇸 Port Orange, Florida, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Dayton Science Institute; 🇺🇸 Dayton, Ohio, United States