Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
Status:
Completed
Trial end date:
2014-10-20
Target enrollment:
Participant gender:
Summary
The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with
methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis
(RA) who are naive to MTX and have with poor prognostic factors, using inhibition of
radiographically confirmed joint damage progression over a one-year period as a primary
endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be
discontinued, and the subjects will be monitored for one more year (the follow-up period) to
investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory
purposes.