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Crohn's DiseasePhase 3NCT00132899

COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial)

A Phase 3 study testing Methotrexate in people with Crohn's Disease, run by University of Western Ontario, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteCanada
Study dates
Dec 2005to Jul 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Robarts Clinical Trials, Robarts Research Institute

    London, Ontario, N6A 5K8

Other trials in Canada

About this study

Official title: A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD)

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.

Read the detailed description

The current approach to the treatment of Crohn's Disease is based on "step care". This strategy is relatively ineffective for the long-term management of patients who require treatment with corticosteroids. Although azathioprine, methotrexate and infliximab are modestly effective in this high-risk population, long-term corticosteroid-free response rates are low. Thus combination therapy is an attractive option to explore. Based on a favourable experience with dual therapy in the treatment of rheumatoid arthritis and the demonstrated efficacy of methotrexate in corticosteroid-dependent CD, we expect that combination therapy with methotrexate and infliximab will be significantly more effective than infliximab monotherapy. Furthermore combined therapy is likely to be highly effective in preventing formation of the antibodies to infliximab that are an important limitation to the continued successful use of this drug.

This is a randomized, placebo-controlled, double-blind, parallel group, multi-centre study. Subjects who have initiated corticosteroid induction therapy within the preceding 6 weeks will be randomized (irrespective of CDAI defined disease activity) in a 1:1 ratio to either methotrexate or placebo for a period of 50 weeks in combination with infliximab administered for 8 infusions. Randomization will be stratified by:

  • Treatment with or without Imuran/6-mercaptopurine in the 2-12 months prior to randomization;
  • Prednisone dose <20 mg or ≥20 mg daily at randomization;
  • CDAI <150 or ≥150 at randomization.
Conditions
Crohn's Disease
Being tested
Methotrexate, Placebo
Keywords
Crohn's Disease, multi-centre randomized placebo-controlled, infliximab, methotrexate, inflammatory bowel disease
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethotrexateDrug

    Methotrexate and infliximab combination

  • PlaceboDrug

    Placebo and infliximab combination therapy.

Study groups in NCT00132899
Study groupRoleWhat they receive
MethotrexateActive comparatorMethotrexate and infliximab combination
Receives: Drug: Methotrexate
PlaceboPlacebo comparatorPlacebo plus infliximab combination
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: one year

Secondary outcomes (3)

  1. 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

    Measured: one year

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

    Measured: one year

  3. Proportion of subjects who develop antibodies to infliximab

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionFeb 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00132899
Sponsor's protocol ID
RP0401
Status last verified
Dec 2005
First submitted
19 Aug 2005
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10342800

  • 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.

    PubMed 15168363

  • 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.

    PubMed 11856078

  • 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.

    PubMed 7481535

  • 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.

    PubMed 24269926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methotrexate in people with Crohn's Disease, run by University of Western Ontario, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00132899, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.

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