COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

NCT00132899 | Completed Phase 3 DMC

• 1 other identifier: RP0401
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohn's disease (CD) in patients with symptoms that are persistent enough to require corticosteroid therapy.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; multi-centre randomized placebo-controlled; infliximab; methotrexate; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Treatment success as defined by the proportion of subjects in clinical remission (i.e. complete discontinuation of prednisone therapy and a CDAI score of <150) at week 14, and maintenance of clinical remission between study weeks 14 and 50

  one year

Secondary Outcomes (3)

• Efficacy of infliximab therapy in combination with methotrexate on disease activity using the Crohn's Disease Activity Index (CDAI) and Investigator and Subject Global Ratings

  one year

• Effects of infliximab therapy in combination with methotrexate on health-related quality of life

  one year

• Proportion of subjects who develop antibodies to infliximab

  one year

Study Arms (2)

Methotrexate

ACTIVE COMPARATOR

Methotrexate and infliximab combination

Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

Placebo plus infliximab combination

Drug: Placebo

Interventions

Methotrexate DRUG

Methotrexate and infliximab combination

Methotrexate

Placebo DRUG

Placebo and infliximab combination therapy.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, or non-pregnant/non-lactating females, 18 or older
• Established Crohn's disease with active symptoms requiring prednisone therapy.
• Females of child-bearing potential must have a negative pregnancy test and must agree to use adequate contraception

You may not qualify if:

• Intolerance or hypersensitivity to infliximab, methotrexate, prednisone and or known allergy to murine proteins or other chimeric proteins
• Are pregnant, nursing, or planning pregnancy (both men and women) during or in the 6 months after the study
• In the 2 months prior to screening, have had a serious infection, or have been hospitalized for and/or treated with intravenous (IV) antibiotics for infection. In the 6 months prior to screening, have had an opportunistic infection.
• After screening, need to continue non-study medical therapy for CD
• In the 8 weeks prior to screening, have received any of the following: systemic steroid therapy, azathioprine, 6-mercaptopurine, cyclosporine, probiotic products, or omega-3 fatty acids
• Have received any of the following: biologics in the last 6 months; methotrexate in the last year; and/or ever received infliximab.
• Have any of the following: biopsy-proven cirrhosis, clinically important lung disease, pre-existing demyelinating disorder, systemic lupus erythematosus, congestive heart failure, diabetes mellitus (insulin dependent), increased risk for steroid-related side effects, body weight 40% higher than standard, human immunodeficiency virus and/or hepatitis B or hepatitis C
• Have any of the following: an active draining fistula as the primary manifestation of CD; documented short bowel syndrome; a stoma; or severe, and/or fixed symptomatic stenosis of the intestine.
• Have had any of the following: clinically important bowel obstruction in the last 3 months; a bowel resection in the last 3 months; and/or other intra-abdominal surgery within 6 months.
• Clinically significant impairment in cardiac, liver or renal function; central nervous system (CNS), pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD; current malignancy or malignancy within 5 years prior to screening.

Sponsors & Collaborators

• University of Western Ontario, Canada: lead
• Schering-Plough: collaborator

Study Sites (1)

Robarts Clinical Trials, Robarts Research Institute

London, Ontario, N6A 5K8, Canada

Location

Related Publications (5)

• Bernstein CN, Blanchard JF, Rawsthorne P, Wajda A. Epidemiology of Crohn's disease and ulcerative colitis in a central Canadian province: a population-based study. Am J Epidemiol. 1999 May 15;149(10):916-24. doi: 10.1093/oxfordjournals.aje.a009735.

  PMID: 10342800 BACKGROUND

• Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17. doi: 10.1053/j.gastro.2004.01.063.

  PMID: 15168363 BACKGROUND

• Loftus EV Jr, Schoenfeld P, Sandborn WJ. The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review. Aliment Pharmacol Ther. 2002 Jan;16(1):51-60. doi: 10.1046/j.1365-2036.2002.01140.x.

  PMID: 11856078 BACKGROUND

• Munkholm P, Langholz E, Davidsen M, Binder V. Disease activity courses in a regional cohort of Crohn's disease patients. Scand J Gastroenterol. 1995 Jul;30(7):699-706. doi: 10.3109/00365529509096316.

  PMID: 7481535 BACKGROUND

• Feagan BG, McDonald JW, Panaccione R, Enns RA, Bernstein CN, Ponich TP, Bourdages R, Macintosh DG, Dallaire C, Cohen A, Fedorak RN, Pare P, Bitton A, Saibil F, Anderson F, Donner A, Wong CJ, Zou G, Vandervoort MK, Hopkins M, Greenberg GR. Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease. Gastroenterology. 2014 Mar;146(3):681-688.e1. doi: 10.1053/j.gastro.2013.11.024. Epub 2013 Nov 21.

  PMID: 24269926 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Brian G Feagan, MD, M.Sc

  Robarts Clinical Trials, Robarts Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: December 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 11, 2013

Record last verified: 2005-12

Locations

CA (1)