Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Rituximab

• Registration Number: NCT00963703
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with documented rheumatoid arthritis by ACR criteria
• Disease duration < 5 years
• May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
• Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
• Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
• Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria

• History of severe allergic or anaphylactic reactions to monoclonal antibodies
• Previous treatment with Rituximab
• Previous treatment with Arava
• Injected with steroids within 4 weeks of day 1 of study
• Treatment with any investigational agent within 4 weeks of day of study
• Any severe or significant medical condition or disease or known active infection
• Pregnancy or nursing at present

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis	Biopsies of inflamed joint at beginning and at week 8 of study

Secondary Outcome Measures

Name	Time	Method
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells	Collected at beginning of study and week 8

Trial Locations

Locations (1)

Arthritis Centre, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada