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Phase 4
19 Years
75 Years
Not Enrolling
DMARD Resistant Rheumatoid Arthritis

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Trial Information

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

- History of malignancies

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

change in 28-joint disease activity index( DAS28)

Outcome Description:

disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)

Outcome Time Frame:

Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.

Safety Issue:



Islamic Repablic of Iran:National ethics committee

Study ID:




Start Date:

July 2010

Completion Date:

October 2011

Related Keywords:

  • DMARD Resistant Rheumatoid Arthritis
  • Rituximab
  • Rheumatoid arthritis
  • Biologics
  • Anti-tumour necrosis factor
  • Disease-modifying anti-rheumatic drugs
  • DAS28
  • European League Against Rheumatism response
  • Arthritis
  • Arthritis, Rheumatoid