Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients were divided 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.

Official Title
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Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Combination Steroid
* Drug: Methotrexate
* Drug: Combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987 Age >18 years Early Rheumatoid Arthritis i.e. less than 2 years duration Patient giving consent to participate in study Disease Modifying Anti-Rheumatic Drugs naive - Exclusion Criteria: Pregnant and lactating patient or planning to conceive in next year Patient who had joint surgery in last 6 months Co morbidities such as liver disease, kidney disease, hematological malignancies Uncontrolled hypertension, diabetes mellitus Coronary artery disease -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate<br>Single agent Methotrexate 15 to 25 mg PO per week | Drug: Methotrexate<br>* Methotrexate 15 to 25 mg PO per week<br>* Other names: Methotrexate 15 to 25 mg PO per week;|
| Active Comparator: Combination<br>Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day | Drug: Combination<br>* Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day<br>* Other names: Sulfasalazine 2000 to 3000 mg per day;|
| Experimental: Combination Steroid<br>Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day Methylprednisolone 1000 mg intravenous per day for 3 days | Drug: Combination Steroid<br>* Methylprednisolone 1000 mg intravenous for 3 days Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg twice daily Sulfasalazine 2000 to 3000 mg per day<br>* Other names: Methylprednisolone 1000 mg intravenous for 3 days;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment | To compare the response (EULAR criteria) to treatment in the three treatment groups. | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Steroid