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

NCT00207675 | Completed Phase 3

• 1 other identifier: CR004786
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Crohn Disease

Keywords

Crohn's Disease; pediatric Crohn's Disease

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

infliximab DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centocor, Inc.: lead
• Centocor BV: collaborator

Related Publications (2)

• 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.

  PMID: 17324398 RESULT

• 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.

  PMID: 19081527 RESULT

Related 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

MeSH Terms

Conditions

Crohn Disease; Pediatric Crohn's disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2003
• Study Completion: August 1, 2007
• Last Updated: May 17, 2011

Record last verified: 2010-03