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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: Combination; Drug: Combination Steroid

• Registration Number: NCT01870128
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2013-05-30
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-03
• Last Update Submitted: 2013-06-03
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	Single agent Methotrexate 15 to 25 mg PO per week
Combination	Combination	Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
Combination Steroid	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

Primary Outcome Measures

Name	Time	Method
Response to treatment	22 months	To compare the response (EULAR criteria) to treatment in the three treatment groups.

Secondary Outcome Measures

Name	Time	Method
Disease activity score (DAS28)	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).

Trial Locations

Locations (1)

AIIMS; 🇮🇳 New Delhi, Delhi, India