Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mashhad University of Medical Sciences
• Collaborator: Roche Pharma AG
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 1987 ACR criteria for classification of RA

• Positive for rheumatoid factor(RF)

• Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 > 3/2

• Patients with active, resistant RA who didn't receive anti TNF agents.

Exclusion Criteria:

• Patient with hypogammaglobulinemia

• Patient with congestive heart failure (classIV)

• Active current bacterial,viral,fungal,myocardial or other infections

• Chronic hepatitis B or hepatitis C carriers

• History of severe allergic reaction to human,humanized or murine monoclonal antibodies

• History of malignancies

• Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.