Clinical trial NCT00207675: A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
pediatric Crohn's Disease
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centocor BV
First posted: 2005-09-21
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: 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:
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.