Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.
This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes|
- To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis [ Time Frame: Biopsies of inflamed joint at beginning and at week 8 of study ] [ Designated as safety issue: No ]
- To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells [ Time Frame: Collected at beginning of study and week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Rituximab 1000 mg Intravenously day 1 and day 15