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A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00207675
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 17, 2011
Centocor BV
Information provided by:
Centocor, Inc.

Brief Summary:
A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: infliximab Phase 3

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  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2003
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207675

Sponsors and Collaborators
Centocor, Inc.
Centocor BV
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

Additional Information:
ClinicalTrials.gov Identifier: NCT00207675     History of Changes
Other Study ID Numbers: CR004786
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: March 2010

Keywords provided by Centocor, Inc.:
Crohn's Disease
pediatric Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents