Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132899
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-08-19
Brief Title:
COMMIT Combination Of Maintenance Methotrexate-Infliximab Trial
Sponsor:
University of Western Ontario Canada
Organization:
University of Western Ontario Canada
Study Overview
Official Title:
A Phase III Randomized Placebo-Controlled Double-Blind Parallel Group Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohns Disease CD
Status:
COMPLETED
Status Verified Date:
2005-12
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 primary objective is to compare the efficacy and safety of infliximab plus methotrexate to infliximab alone for the long-term control of signs and symptoms of Crohns disease CD in patients with symptoms that are persistent enough to require corticosteroid therapy
Detailed Description:
The current approach to the treatment of Crohns Disease is based on step care This strategy is relatively ineffective for the long-term management of patients who require treatment with corticosteroids Although azathioprine methotrexate and infliximab are modestly effective in this high-risk population long-term corticosteroid-free response rates are low Thus combination therapy is an attractive option to explore Based on a favourable experience with dual therapy in the treatment of rheumatoid arthritis and the demonstrated efficacy of methotrexate in corticosteroid-dependent CD we expect that combination therapy with methotrexate and infliximab will be significantly more effective than infliximab monotherapy Furthermore combined therapy is likely to be highly effective in preventing formation of the antibodies to infliximab that are an important limitation to the continued successful use of this drug
This is a randomized placebo-controlled double-blind parallel group multi-centre study Subjects who have initiated corticosteroid induction therapy within the preceding 6 weeks will be randomized irrespective of CDAI defined disease activity in a 11 ratio to either methotrexate or placebo for a period of 50 weeks in combination with infliximab administered for 8 infusions Randomization will be stratified by
Treatment with or without Imuran6-mercaptopurine in the 2-12 months prior to randomization
Prednisone dose 20 mg or 20 mg daily at randomization
CDAI 150 or 150 at randomization
This is a randomized placebo-controlled double-blind parallel group multi-centre study Subjects who have initiated corticosteroid induction therapy within the preceding 6 weeks will be randomized irrespective of CDAI defined disease activity in a 11 ratio to either methotrexate or placebo for a period of 50 weeks in combination with infliximab administered for 8 infusions Randomization will be stratified by
Treatment with or without Imuran6-mercaptopurine in the 2-12 months prior to randomization
Prednisone dose 20 mg or 20 mg daily at randomization
CDAI 150 or 150 at randomization
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