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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207675

Enrollment

112

Registered

2005-09-21

Start date

2003-02-28

Completion date

2007-08-31

Last updated

2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn's Disease, pediatric Crohn's Disease

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.

Interventions

DRUGinfliximab

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026