Rheumatoid Arthritis Clinical Trial
Official title:
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987 2. Age >18 years 3. Early Rheumatoid Arthritis i.e. less than 2 years duration 4. Patient giving consent to participate in study 5. Disease Modifying Anti-Rheumatic Drugs naive - Exclusion Criteria: 1. Pregnant and lactating patient or planning to conceive in next year 2. Patient who had joint surgery in last 6 months 3. Co morbidities such as liver disease, kidney disease, hematological malignancies 4. Uncontrolled hypertension, diabetes mellitus 5. Coronary artery disease - |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | AIIMS | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to treatment | To compare the response (EULAR criteria) to treatment in the three treatment groups. | 22 months | No |
Secondary | Disease activity score (DAS28) | To compare the disease activity score (DAS28) score and its defining variables (tender joint count, swollen joint count, erythrocyte sedimentation rate and patient global assessment on visual analogue scale). | 22 months | No |
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