Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269867
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2005-12-22
Brief Title:
Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Placebo-Controlled Double-Blinded Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody cA2 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment
Status:
COMPLETED
Status Verified Date:
2014-11
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 this study is to evaluate the safety and effectiveness of infliximab an anti-TNF chimeric monoclonal antibody cA2 in patients with active Rheumatoid Arthritis despite methotrexate treatment
Detailed Description:
This is a placebo-controlled double-blinded randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis despite methotrexate treatment Infliximab is an anti-TNF chimeric monoclonal antibody cA2 The primary measures of effectiveness include the change from baseline in American College of Rheumatology ACR20 response at week 30 and the change in the modified van der Heijde Sharp Score The ACR20 Responder Index a composite of clinical laboratory and functional measures and the van der Heijde-Sharp vdH-S scoring method is a method of rating structural damage in patients
Patients will be treated with either infliximab or matching placebo
Patients will be treated with either infliximab or matching placebo
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