Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004941
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody cA2 for Patients With Enterocutaneous Fistulae as a Complication of Crohns Disease
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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:
OBJECTIVES
I Evaluate the efficacy of chimeric monoclonal antibody cA2 compared with placebo in closure of enterocutaneous fistulae in patients with Crohns disease
I Evaluate the efficacy of chimeric monoclonal antibody cA2 compared with placebo in closure of enterocutaneous fistulae in patients with Crohns disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to investigational site and number of fistulae single vs multiple
Patients are randomized to one of three treatment arms Arm I Patients receive an infusion of chimeric monoclonal antibody cA2 on weeks 0 2 and 6 Arm II Patients receive an infusion of cA2 on weeks 0 and 2 and an infusion of placebo on week 6 Arm III Patients receive an infusion of placebo on day 1 of weeks 0 2 and 6
Patients are followed every month for 3 months then every 6-12 months for up to 2 years
Patients are randomized to one of three treatment arms Arm I Patients receive an infusion of chimeric monoclonal antibody cA2 on weeks 0 2 and 6 Arm II Patients receive an infusion of cA2 on weeks 0 and 2 and an infusion of placebo on week 6 Arm III Patients receive an infusion of placebo on day 1 of weeks 0 2 and 6
Patients are followed every month for 3 months then every 6-12 months for up to 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CENTOCOR-FDR001276 | None | None | None |
| CENTOCOR-C0168T20 | None | None | None |