NCT03263715

A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double- blind, controlled fashion, focussing on glucocorticoid-free remission of disease.

Detailed description

Background. Polymyalgia rheumatica is an inflammatory rheumatic disease of the elderly, with a usually rapid response to intermediate-doses of glucocorticoids (GCs). In many patients, relapses occur upon its dose reduction or cessation. Given the patients' age and the adverse event profile of GCs, steroid- free remission is the most desired target in patients with PMR, but typical GC sparing agents are often insufficient. Case series and small open studies suggested an excellent effectiveness of tocilizumab, an inhibitor of the Interleukin 6-receptor. Objective. To assess the efficacy and safety of a tocilizumab-based regimen compared with placebo on top of rapidly tapered GC treatment in a double-blind, controlled fashion, focussing on GC-free remission of disease. Methods. In this double-blind, parallel group study, 32 patients with PMR will be recruited from three rheumatology centres and will be randomised in a 1:1 ratio to tocilizumab or placebo over the course of 16 weeks, accompanied by a rapid tapering GC scheme over 11 weeks in both arms. The primary endpoint is GC-free remission at week 16, and follow-up will be performed until week 24 for safety and sustained efficacy. Patients will receive either the subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections. Expected Results. In case of a positive result of this study, the benefits for patients with new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly population with increased risk of GC-related adverse events.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Tocilizumab Prefilled Syringe [Actemra]	Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.
DRUG	Placebos	Weekly administration of Placebo subcutaneous from Baseline to Week 16.
DRUG	Glucocorticoids	Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg

Timeline

• Start date: 2017-11-24
• Primary completion: 2020-06-02
• Completion: 2020-06-02
• First posted: 2017-08-28
• Last updated: 2021-01-22

Locations

3 sites across 1 country: Austria