A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE�) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
2 other identifiers
interventional
60
5 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2006
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 13, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
August 10, 2011
CompletedJuly 30, 2013
July 1, 2013
2.7 years
June 9, 2006
July 14, 2011
July 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants With Clinical Response at Week 8
Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by \>=30% and \>= 3 points, with a decrease in the rectal bleeding subscore \>=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.
Week 8
Secondary Outcomes (1)
The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54
Week 54
Study Arms (2)
002
EXPERIMENTALinfliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42
001
EXPERIMENTALinfliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46
Interventions
infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (27)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
New Hyde Park, New York, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Antwerp, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Edmonton, Canada
Unknown Facility
Halifax, Canada
Unknown Facility
Hvidovre, Denmark
Unknown Facility
Rotterdam, Netherlands
Related Publications (1)
Singh S, Proudfoot JA, Dulai PS, Jairath V, Fumery M, Xu R, Feagan BG, Sandborn WJ. No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials. Am J Gastroenterol. 2018 Aug;113(8):1197-1205. doi: 10.1038/s41395-018-0144-2. Epub 2018 Jun 21.
PMID: 29925913DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Research
- Organization
- Johnson & Johnson Pharmaceutical Research and Development
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2006
First Posted
June 13, 2006
Study Start
September 1, 2006
Primary Completion
May 1, 2009
Study Completion
April 1, 2010
Last Updated
July 30, 2013
Results First Posted
August 10, 2011
Record last verified: 2013-07