A Study of MDX-1100 in Subjects With Active Ulcerative Colitis (MDX1100-06)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00656890
First received: April 4, 2008
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Biological: sterile saline for injection
Biological: MDX-1100
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change in Mayo score at Day 57 compared with Screening [ Time Frame: Day 57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the remission rate [ Time Frame: Day 57 ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
sterile saline for injection
Biological: sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
Experimental: 1
MDX-1100 for injection
Biological: MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656890

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00656890     History of Changes
Other Study ID Numbers: MDX1100-06, IM129-004
Study First Received: April 4, 2008
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
ulcerative colitis, rectal bleeding

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014