Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Study of an Investigational Study Drug for Early Polymyalgia Rheumatica
Study Overview
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 Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Polymyalgia Rheumatica
-
Age: 50 years or above
-
Gender: All
Inclusion Criteria:
- Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
- Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg/d prednisone)
- Participants must be willing and able to take prednisone of 15 mg/day at randomization
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion Criteria:
- Diagnosis of Giant Cell Arteritis (GCA)
- Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
- Inadequately treated hypothyroidism
- Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
- Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
- Immunosuppressive therapies including systemic corticosteroids
- Malignancy
- Organ transplant recipient
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
The purpose of this research study is to learn about the effects and safety of an investigational study drug in adults with early polymyalgia rheumatica (PMR). This study includes people who are newly diagnosed with PMR or who have early relapsing PMR (their PMR flared again within the past year after starting steroid treatment).
Participants will receive either the investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication. Participants will also take prednisone (a corticosteroid) with a planned taper (slow dose decrease) over time.
Who can participate:
Adults with early polymyalgia rheumatica (PMR) may be able to participate if they:
- Are 50 years old or older and meet standard criteria for PMR
- Are newly diagnosed (have used corticosteroids for 6 weeks or less), or have early relapsing PMR after starting prednisone within the past year
- Are willing and able to take prednisone at the start of the study
Study timeline and visits:
There will be 14 study visits, from screening through about 58 weeks.
Find a study site near you
,
Send a message
Enter your contact details to connect with study team
Primary Contact
Please choose between Voice or SMS based delivery of verification code
or