A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Status:
Terminated
Trial end date:
2013-01-29
Target enrollment:
Participant gender:
Summary
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled,
parallel group design, with a follow-up period up to a total study duration of 6-month,
non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare.
It is a multicentric, multinational study. The protocol will seek to enroll a total of 30
patients, who will be randomized to the 3 arms at a ratio of 1:1:1.
Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing
period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after
their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the
case of a disease flare.