A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00336492
First received: June 9, 2006
Last updated: July 24, 2013
Last verified: July 2013

June 9, 2006
July 24, 2013
September 2006
May 2009   (final data collection date for primary outcome measure)
The Number of Participants With Clinical Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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.
The primary objectives of this study are to evaluatethe efficacy of infliximab in inducing a clinical response at week 8 inpediatric patients with UC and to evaluate the safety profile of infliximabduring induction and maintenance treatment.
Complete list of historical versions of study NCT00336492 on ClinicalTrials.gov Archive Site
The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.
The secondary objectives of this study are to evaluatethe efficacy of infliximab in inducing clinical remission and mucosal healing at week 8; Compare two dosing regimens in maintaining clinical response and remission at week 54
Not Provided
Not Provided
 
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

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.

Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "Antibodies" are normally made in the body and help fight off infection. Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to do any damage. This study will be done at centers in North America and Europe. Each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. At the 2nd visit (week 0), the child will have the first treatment with infliximab. All children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. If the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. A final infusion will be given at either week 42 or week 46. There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous infusion over 2 hours.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
  • Biological: infliximab
    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
  • Biological: infliximab
    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
  • Biological: infliximab
    infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42
  • Biological: infliximab
    infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
  • Experimental: 002
    infliximab 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
    Interventions:
    • Biological: infliximab
    • Biological: infliximab
  • Experimental: 001
    infliximab 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:
    • Biological: infliximab
    • Biological: infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   Netherlands
 
NCT00336492
CR012388, C0168T72
Not Provided
Centocor, Inc.
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP