Evaluation of efficacy and safety of Sarilumab in patients with PMR
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica
IRAS ID
248765
Contact name
Christelle Merlo
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2017-002989-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1201-0777 , WHO universal trail number
Duration of Study in the UK
2 years, 1 months, 19 days
Research summary
Polymyalgia Rheumatica (PMR), presents as a widespread aching and stiffness of the shoulders and sometimes hips. Patients with PMR might experience difficulty with raising their arms or lifting their leg.
The main treatment for PMR is low-dose corticosteroids. Patients may need to receive a low dose of corticosteroid for 2-3 years. Unfortunately, even this low dose of corticosteroid can cause many side effects such as high blood sugar, weight gain, sleeplessness, thinning of the bones and skin, high blood pressure, muscle weakness and bruising.
Interleukin-6 (IL-6) is a protein in the immune system that has been shown to play an important role in PMR. To treat PMR, recent studies have suggested that it may be beneficial to block the activity of this IL-6 protein. Sarilumab, the study medication, belongs to a class of drugs called monoclonal antibodies and acts to block the receptor of the IL-6 protein.
In this study, sarilumab will be used together with prednisone (a type of corticosteroid) to see if the combined treatment is effective and safe for treatment of PMR. Additionally, the study will determine if sarilumab may allow patients with PMR to get off the prednisone treatment quicker while still keeping the PMR under control.
A total of 280 people with PMR will enter the study. Half will be treated with Sarilumab and prednisone, and the other half will receive placebo and prednisone. Treatment will be assigned randomly. The study will last up to 62 weeks and is made up of 3 periods: Screening (4 weeks), Treatment (52 weeks) and Follow-up (6 weeks).
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0015
Date of REC Opinion
19 Feb 2019
REC opinion
Further Information Favourable Opinion