Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

University of Manitoba

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00963703

B2007:160

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Rituximab

Experimental group

Treatment:

Drug: Rituximab