Sarilumab Doses for Early Polymyalgia Rheumatica
This study aims to evaluate if sarilumab can help achieve and maintain long-term remission in individuals with early relapsing polymyalgia rheumatica over a 52-week period.
Sarilumab
+ Placebo
Connective Tissue Diseases+3
+ Muscular Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: April 15, 2026
Actual date on which the first participant was enrolled.The study aims to find out if the medication sarilumab, given at two different doses, is effective and safe for adults who have early polymyalgia rheumatica (PMR), a condition that causes muscle pain and stiffness. This study is important because it could offer a new treatment option for people with PMR, potentially improving their quality of life. The study involves comparing sarilumab to a placebo, both combined with a 52-week course of prednisone, a common steroid medication used to treat PMR. By exploring these treatment options, the study hopes to address the ongoing need for effective PMR treatments. Participants in the study will be randomly assigned to receive either 150 mg or 200 mg of sarilumab every two weeks or a placebo, along with a gradual reduction of prednisone over 52 weeks. The study will run over multiple visits, starting with a screening visit, followed by the first dose and baseline measurements, and continuing through regular treatment visits. The effectiveness of the treatment will be evaluated by checking for sustained remission, meaning no signs or symptoms of PMR, at the end of the study period. The study will also monitor any potential side effects to ensure the safety of the treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives