Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

Condition(s) studied

Investigational drug(s) / intervention(s)

Sarilumab: Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Sarilumab: Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Placebo: Pharmaceutical form: Solution for injection - Route of administration: Subcutaneous

Study summary

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens.

The study will consist of the following visits:

Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.

Eligibility

Primary outcome measure(s)

• Sustained remission at Week 52 (yes/no) in participants with early relapsing polymyalgia rheumatica (PMR) who received sarilumab 200 mg q2w with 52-week prednisone taper — at Week 52
  No signs or symptoms of PMR at Week 24 and sustained through week 52 (without use of rescue therapy).

Trial sites (74)

+ 34 more sites — see the full list on the official registry below.

On this site

More Sanofi trials in Belgium

Other trials for the same condition