Rheumatoid Arthritis Clinical Trial
Official title:
Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)
A study to determine the efficacy and safety of rituximab in Pakistani patients with rheumatoid arthritis (RA) who have been inadequately controlled with standard disease modifying anti rheumatic drugs (DMARDs).
Enrolled subjects with inadequately-controlled RA had their disease activity level assessed
before initiation of therapy and at intervals of 6 months and 12 months thereafter.
Standardized disease activity scores like the Disease Activity Score-28 (DAS 28) were used
for determining remission or otherwise of the disease. The American College of Rheumatology
(ACR) 20, 50 and 70 response scores and the European League of Associations for Rheumatology
(EULAR) Response Criteria for RA were used to determine the percentage improvement in the
individual subject's condition at the same intervals. The former utilizes a set of
assessments to determine if, after a given therapy, there has been a 20, 50 or 70%
improvement in the aggregate scores as compared to the baseline and the latter utilizes
calculated improvements in the DAS 28 score to determine if the response to treatment has
been good, moderate or none. Both of these have been validated and approved for use by the
ACR and EULAR respectively.
The study enrollment period was from 1st January 2010 till 31st December 2010. Observation
period was 12 months from the enrollment date for each subject. The final results are being
reported here.
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