Abatacept Treatment in Polymyositis and Dermatomyositis
Status:
Completed
Trial end date:
2013-11-28
Target enrollment:
Participant gender:
Summary
The aim of this study is to investigate the efficacy and safety of abatacept in patients with
Dermatomyositis (DM) and polymyositis (PM) refractory to conventional treatment using a
randomised trial design with delayed start in one arm. Abatacept will be administered
intravenously to participants at a dose based on body weight at the screening visit followed
by six follow-up treatments (Active treatment arm). Abatacept will also be administered
intravenously to participants at a dose based on body weight starting at 3 months followed by
six follow-up treatments (Delayed-onset treatment arm). The International Myositis Assessment
and Clinical Studies Group (IMACS) preliminary definition of improvement (DOI) will be used
for assessment.
Phase:
Phase 2
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Institute of Rheumatology, Prague Institute of Rheumatology, Prague, Czech Republic King's College Hospital NHS Trust