A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
May 16, 2011 updated by: Centocor, Inc.
A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease.
A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease
Study Overview
Detailed Description
This is a medical research study to evaluate the safety and effectiveness of an antibody called infliximab (Remicade) in the treatment of children with Crohn's disease.
In this study, subjects will receive multiple doses of infliximab over 62 weeks.
The goal of the study is to ensure that the medication is safe and effective in children when it is given for an extended period of time.
All subjects will receive an induction regimen of 5 mg/kg infliximab at Weeks 0, 2, and 6.
Subjects will then receive either 5 or 10 mg/kg infliximab either every 8 or 12 weeks for up to 46 weeks followed by an open label extension for up to three additional years.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 6 and 17 years
- Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy
- Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX).
Exclusion Criteria:
- Disease complications for which surgery might be indicated
- Surgery for bowel diversion with placement of a stoma within 3 months prior to screening
- Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical response at Week 10, defined as a decrease from baseline in the PCDAI score of at least 15 points with a total score of no more than 30 points at Week 10.
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Secondary Outcome Measures
Outcome Measure |
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Clinical response at Week 54; Clinical remission at Week 54; Change from baseline in corticosteroid use at Week 54; Change from baseline in height status at Week 54
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hyams J, Crandall W, Kugathasan S, Griffiths A, Olson A, Johanns J, Liu G, Travers S, Heuschkel R, Markowitz J, Cohen S, Winter H, Veereman-Wauters G, Ferry G, Baldassano R; REACH Study Group. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children. Gastroenterology. 2007 Mar;132(3):863-73; quiz 1165-6. doi: 10.1053/j.gastro.2006.12.003. Epub 2006 Dec 3.
- Thayu M, Leonard MB, Hyams JS, Crandall WV, Kugathasan S, Otley AR, Olson A, Johanns J, Marano CW, Heuschkel RB, Veereman-Wauters G, Griffiths AM, Baldassano RN; Reach Study Group. Improvement in biomarkers of bone formation during infliximab therapy in pediatric Crohn's disease: results of the REACH study. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1378-84. doi: 10.1016/j.cgh.2008.07.010.
Helpful Links
- A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, REMICADE�) in Pediatric Subjects with Moderate to Severe Crohn's Disease
- |A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, REMICADE®) in Pediatric Subjects with Moderate to Severe Crohn's Diseas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Completion (ACTUAL)
August 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 17, 2011
Last Update Submitted That Met QC Criteria
May 16, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004786
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.