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

This study has been completed.
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00207675
First received: September 13, 2005
Last updated: May 16, 2011
Last verified: March 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Crohn Disease
 Drug: infliximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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.

Resource links provided by NLM:

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

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 112
Study Start Date: February 2003
Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207675

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

Additional Information:
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  This link exits the ClinicalTrials.gov site
/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  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00207675     History of Changes
Other Study ID Numbers: CR004786
Study First Received: September 13, 2005
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013