Rheumatoid Arthritis Clinical Trial
Official title:
Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables in relation to disease activity and radiographic outcome in patients with RA who start treatment with Remicade at 24 weeks.
This is an open-lable, single arm study of the ultrasonographic monitoring of response to
infliximab in patients with rheumatoid arthritis. Approximately 120 subjects will be
enrolled. Subjects will receive infliximab 3mg/kg intravenous infusion at 0, 2, 6 week, and
then repeated every 8 weeks until 24 weeks.
The efficacy assessment is observed by ACR response, HAQ, DAS28, sharp scores and US
assessment at 0,2，6,14, 22, and 24weeks and ultrosonographic and radiographic assessments
are conducted at 0, 6,and 24weeks.
Subjects will be followed for AEs and SAEs up to 8 weeks following the last study treatment
administration (see Section 6).
The end of study is defined as the time the last subject completes the 24 weeks visit.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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