Phase 3
Completed N=60
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Ulcerative Colitis
Source: ClinicalTrials.gov NCT00336492 ↗
Enrolled (actual)
60
Serious AEs
23.3%
Results posted
Aug 2011
Primary outcomePrimary: The Number of Participants With Clinical Response at Week 8 — 44 Participants
Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With Clinical Response at Week 8 |
44 | — |
| SECONDARY The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54 |
8; 4 | 0.146 |
Eligibility Criteria
Inclusion Criteria
- Have moderately to severely active ulcerative colitis
- Diagnosed with ulcerative colitis for 2 weeks before screening
- Male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion.
Exclusion Criteria
- History of latent or active TB
- Have had a live viral or bacterial vaccination within 3 months before screening
- Have or have had serious infections within 3 months before screening
- Prior treatment with infliximab
Data sourced from ClinicalTrials.gov (NCT00336492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.