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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00656890
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 4, 2008
First Posted Date  ICMJE April 11, 2008
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
Change in Mayo score at Day 57 compared with Screening [ Time Frame: Day 57 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
the remission rate [ Time Frame: Day 57 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MDX-1100 in Subjects With Active Ulcerative Colitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Biological: sterile saline for injection
    10mg/kg/dose sterile saline injected every other week for a total of 4 doses
  • Biological: MDX-1100
    10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
Study Arms  ICMJE
  • Placebo Comparator: 2
    sterile saline for injection
    Intervention: Biological: sterile saline for injection
  • Experimental: 1
    MDX-1100 for injection
    Intervention: Biological: MDX-1100
Publications * Mayer L, Sandborn WJ, Stepanov Y, Geboes K, Hardi R, Yellin M, Tao X, Xu LA, Salter-Cid L, Gujrathi S, Aranda R, Luo AY. Anti-IP-10 antibody (BMS-936557) for ulcerative colitis: a phase II randomised study. Gut. 2014 Mar;63(3):442-50. doi: 10.1136/gutjnl-2012-303424. Epub 2013 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2008)
106
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czech Republic,   Hungary,   Latvia,   Romania,   Russian Federation,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00656890
Other Study ID Numbers  ICMJE MDX1100-06
IM129-004 ( Other Identifier: BMS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP