DMARD Resistant Rheumatoid Arthritis Clinical Trial
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | October 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 75 Years |
| Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Rheumatic Diseases Research Center, Mashhad University of Medical Sciences | Mashhad | Khorasan Razavi |
| Lead Sponsor | Collaborator |
|---|---|
| Mashhad University of Medical Sciences | Roche Pharma AG |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Primary | Change in European league against rheumatism(EULAR) response criteria | Change in EULAR 2,16,24 weeks | No | |
| Secondary | Rituximab side effects | side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection. | 0,2,16,24 weeks | Yes |