The Chinese University of Hong Kong Early Arthritis Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes in the volume of enhancing synovitis measured by Magnetic Resonance Imaging(MRI) as it corresponds to active, inflamed tissue and is therefore expected to be a better marker of disease activity.
week 24
Yes
Edmund K Li, MD
Principal Investigator
Chinese University of Hong Kong
Hong Kong: Department of Health
ERA_2008
NCT00901550
November 2008
October 2011
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