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NCT Number: NCT01870128

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AIIMS

New Delhi, National Capital Territory of Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Combination Steroid

Drug

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

Other names: Methylprednisolone 1000 mg intravenous for 3 days

methotrexate

Drug

Methotrexate 15 to 25 mg PO per week

Other names: Methotrexate 15 to 25 mg PO per week

Combination

Drug

Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day

Other names: Methotrexate 15 to 25 mg PO per week, Hydroxychloroquine 200 mg Twice daily, Sulfasalazine 2000 to 3000 mg per day

Primary outcomes

  1. Response to treatment

    Time frame: 22 months

    To compare the response (EULAR criteria) to treatment in the three treatment groups.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 5, 2013
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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