An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
Status:
Completed
Trial end date:
2018-06-04
Target enrollment:
Participant gender:
Summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will
evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will
consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week
open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants
will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or
placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52,
participants in remission will stop study treatment and enter long-term follow-up, whereas
participants with disease activity or flares will receive open-label tocilizumab or other
treatment at the discretion of the investigator for a maximum period of 104 weeks.