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

NCT ID: NCT00336492

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-04-30

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.

Detailed Description

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

infliximab

Intervention Type: BIOLOGICAL

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

infliximab

Intervention Type: BIOLOGICAL

infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42

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

Group Type: EXPERIMENTAL

infliximab

Intervention Type: BIOLOGICAL

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

infliximab

Intervention Type: BIOLOGICAL

infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42

Interventions

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

infliximab

infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42

Intervention Type: BIOLOGICAL

infliximab

infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Los Angeles, California, United States

Denver, Colorado, United States

Hartford, Connecticut, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Rochester, Minnesota, United States

New Hyde Park, New York, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Providence, Rhode Island, United States

Milwaukee, Wisconsin, United States

Antwerp, , Belgium

Leuven, , Belgium

Vancouver, British Columbia, Canada

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Edmonton, , Canada

Halifax, , Canada

Hvidovre, , Denmark

Rotterdam, , Netherlands

Countries

United States; Belgium; Canada; Denmark; Netherlands

References

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.

Reference Type: DERIVED

PMID: 29925913 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=174&filename=CR012388_CSR.pdf

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

Other Identifiers

C0168T72

Identifier Type: OTHER

Identifier Source: secondary_id

CR012388

Identifier Type: -

Identifier Source: org_study_id