Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336492
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2006-06-09
Brief Title:
A Study of the Safety and Efficacy of InfliximabREMICADE in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkg infliximab 3 times at weeks 0 2 and 6 over the first 6 weeks of the study If the childs symptoms do not improve by the 8th week the child will receive no further infusions but will return for safety evaluations If the childs symptoms do improve the child will be randomly assigned like the flip of a coin to either 5 mgkg infliximab every 8 weeks through week 46 or 5 mgkg 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 mgkg of infliximab at weeks 0 2 and 6 and then 5mgkg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46 Infliximab is given as an intravenous infusion over 2 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C0168T72 | OTHER | Centocor | None |