Rheumatoid Arthritis Clinical Trial
Official title:
The Chinese University of Hong Kong Early Arthritis Study
The purpose of this study is:
1. To ascertain whether the quantitative assessment of enhancing synovial volume and
perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful
indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using
biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.
2. To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with
Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).
This was a 24-week open-label randomized study. Forty patients are randomly assigned to
receive either combination infliximab plus Methotrexate(MTX) (n=20) or Methotrexate(MTX)
alone (n=20)
All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with
persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5
mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 Patients in
combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week
thereafter. Comprehensive assessment will be made on week 0, 12, 24.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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