NCT01791153

An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)

A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
DRUG	Prednisone	Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
DRUG	Tocilizumab Placebo	Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
DRUG	Prednisone Placebo	Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
DRUG	Corticosteroids	Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
DRUG	Methotrexate	Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.

Timeline

• Start date: 2013-07-22
• Primary completion: 2016-04-11
• Completion: 2018-06-04
• First posted: 2013-02-13
• Last updated: 2020-02-06
• Results posted: 2017-05-18

Locations

78 sites across 14 countries: United States, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom