Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Study of an Investigational Study Drug With Prednisone 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
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Age: 50 years or above
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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 when taken along with prednisone in adults with early polymyalgia rheumatica (PMR). The study includes people who are newly diagnosed with PMR or who have early relapsing PMR (their symptoms came back after starting steroid treatment within the past year).
Participants will receive 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, and the prednisone dose will be slowly lowered over about one year.
Who can participate:
Adults with polymyalgia rheumatica (PMR) may be able to participate if they:
- Are age 50 or older
- Have newly diagnosed PMR and have used corticosteroids (such as prednisone) for 6 weeks or less, or have early relapsing PMR after starting corticosteroids within the past year
- Can take prednisone 15 mg per day at the start of the study
- Do not have giant cell arteritis
Study timeline and visits:
Participation lasts about 58 weeks. There are 14 study visits, including a screening visit, a baseline visit, treatment visits through week 52, and a final visit at week 58.
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