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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2011

Detailed Description

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.

Interventions

  • Drug: Combination Steroid
    • 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
  • Drug: Methotrexate
    • Methotrexate 15 to 25 mg PO per week
  • Drug: Combination
    • Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day

Arms, Groups and Cohorts

  • Active Comparator: Methotrexate
    • Single agent Methotrexate 15 to 25 mg PO per week
  • Active Comparator: Combination
    • Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
  • Experimental: Combination Steroid
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Response to treatment
    • Time Frame: 22 months
    • To compare the response (EULAR criteria) to treatment in the three treatment groups.

Secondary Measures

  • Disease activity score (DAS28)
    • Time Frame: 22 months
    • 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).

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Principal Investigator: Atul Batra, Senio Resident – All India Institute of Medical Sciences, New Delhi
  • Overall Official(s)
    • ATUL BATRA, MD, Principal Investigator, All India Institute of Medical Sciences, New Delhi

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