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

Study Overview
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Brief Summary
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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.

Conditions
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DMARD Resistant Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Rituximab
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rituximab<br> | Drug: Rituximab<br>* two 500 mg rituximab infusions 2 weeks apart<br>* Other names: Mabthera;Drug: Rituximab<br>* 500mg,two times with two weeks interval<br>* Other names: Mabthera;|
| Active Comparator: Methotrexate<br> | Drug: Rituximab<br>* two 500 mg rituximab infusions 2 weeks apart<br>* Other names: Mabthera;Drug: Rituximab<br>* 500mg,two times with two weeks interval<br>* Other names: Mabthera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 28-joint disease activity index( DAS28) | disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR) | Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks. | 
| Change in European league against rheumatism(EULAR) response criteria |  | Change in EULAR 2,16,24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rituximab side effects | side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection. | 0,2,16,24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, European League Against Rheumatism response, DAS28