Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica
Eligibility Criteria
Inclusion criteria :
- Diagnosis of PMR according to European League Against Rheumatism/American College of Rheumatology classification criteria.
- Participants must be on prednisone of at least 7.5 milligrams per day (mg/day) (or equivalent) and not exceeding 20 mg/day at screening and during the screening period.
- Participant was willing and able to take prednisone of 15 mg/day at randomization.
- Participants had a history of being treated for at least 8 weeks with prednisone (greater than or equal to [>=]10 mg/day or equivalent).
Participants must have had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that was >= 7.5 mg/day (or equivalent) within the past 12 Weeks prior to screening:
- Unequivocal symptoms of PMR flare included shoulder and/or hip girdle pain associated with inflammatory stiffness.
- Participants had erythrocyte sedimentation rate >=30 millimeters per hour (mm/hr) and/or C-reactive protein >=10 milligrams per liter (mg/L) associated with PMR disease activity within 12 weeks prior to screening.
Exclusion criteria:
- Diagnosis of giant cell arteritis (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, extremity claudication, blurry or loss of vision, symptoms of stroke).
- Diagnosis of active fibromyalgia.
- Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis.
- Concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases.
- Inadequately treated hypothyroidism.
- Organ transplant recipient.
- Therapeutic failure including inadequate response or intolerance, or contraindication, to biological interleukin-6 antagonist.
Any prior (within the defined period below) or concurrent use of immunosuppressive therapies but not limited to any of the following:
- Janus kinase inhibitor within 4 weeks of Baseline.
- Alkylating agents including cyclophosphamide within 6 months of Baseline.
- Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to Baseline level.
- Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever was longer.
- Abatacept within 8 weeks of Baseline.
- Anakinra within 1 week of Baseline.
- Cyclosporine, azathioprine or mycophenolate mofetil or leflunomide within 4 weeks of Baseline.
- Unstable methotrexate (MTX) dose and/or MTX dose greater than (>) 15 mg/week within 3 months of Baseline
- Concurrent use of systemic CS for conditions other than PMR.
- Pregnant or breastfeeding woman.
- Participants with active or untreated latent tuberculosis.
- Participants with history of invasive opportunistic infections.
- Participants with fever associated with infection or chronic, persistent or recurring infections required active treatment.
- Participants with uncontrolled diabetes mellitus.
- Participants with non-healed or healing skin ulcers.
- Participants who received any live, attenuated vaccine within 3 months of Baseline.
- Participants who were positive for hepatitis B, hepatitis C and/or human immunodeficiency virus.
- Participants with a history of active or recurrent herpes zoster.
- Participants with a history of or prior articular or prosthetic joint infection.
- Prior or current history of malignancy.
- Participants who have had surgery within 4 weeks of screening or planned surgery during study.
- Participants with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 8400003
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- Investigational Site Number 8260001
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo+52 Week Taper
Sarilumab 200mg q2w+14 Week Taper
Participants received sarilumab-matching placebo as subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone/prednisone-matching placebo tapering oral daily doses for 52 weeks.
Participants received sarilumab 200 milligrams (mg) as SC injection q2w up to 52 weeks along with the combination of prednisone and/or prednisone-matching placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 14 weeks and prednisone-matching placebo from Week 14 up to Week 52.