Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)(COMPLETED)
This study has been completed.
Information provided by:
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
This is an open-label program of Remicade in the treatment of patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX) to determine the onset of efficacy of infliximab.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Define the onset of efficacy of infliximab in patients with active RA, using the validated SF-36 questionnaire. [ Time Frame: After the first 2 weeks of treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
|Study Completion Date:||April 2004|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Remicade in the treatment of patients with active RA despite treatment with MTX.
Biological: Infliximab (Remicade)
Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6. All patients will continue to receive the same dose of MTX they were receiving at entry throughout the subsequent treatment period.
Contacts and Locations
No Contacts or Locations Provided