Overview

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

Status:
Completed

Trial end date:
2011-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

All India Institute of Medical Sciences, New Delhi

Treatments:

Hydroxychloroquine
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Sulfasalazine

Criteria

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 -