A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica

Sanofi-Aventis Recherche & Développement0 sites500 target enrollmentOctober 16, 2018

Overview

No summary available.

Registry

who.int

Start Date

October 16, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Diagnosis of polymyaglia rheumatica (PMR) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
•\-Patients must be on prednisone of at least 7\.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period.
•\-Patient is willing and able to take prednisone of 15 mg/day at randomization.
•\-Patients must have a history of being treated for at least 8 weeks with prednisone (\=10 mg/day or equivalent).
•\-Patient must have had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is \=7\.5 mg/day (or equivalent) within the past 12 Weeks prior to screening:
•\-Unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated with inflammatory stiffness.
•\-Patients must have erythrocyte sedimentation rate \=30 mm/hr and/or C\-reactive protein \=10 mg/L associated with PMR disease activity within 12 weeks prior to screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\-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 IL\-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.