Evaluation of the Efficacy and Safety of Sarilumab in Patients withPolymyalgia Rheumatica
- Conditions
- Polymyalgia rheumaticaMedDRA version: 21.0Level: PTClassification code 10036099Term: Polymyalgia rheumaticaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-002989-42-IT
- Lead Sponsor
- SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
-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
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 375
-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.
-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 is 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 >15mg/week
within 3 months of baseline.
-Concurrent use of systemic CS for conditions other than PMR.
-Pregnant or breastfeeding woman.
-Patients with active or untreated latent tuberculosis.
-Patients with history of invasive opportunistic infections.
-Patients with fever associated with infection or chronic, persistent or
recurring infections requiring active treatment.
-Patients with uncontrolled diabetes mellitus.
-Patients with non-healed or healing skin ulcers.
-Patients who received any live, attenuated vaccine within 3 months of
baseline.
-Patients who are positive for hepatitis B, hepatitis C and/or HIV.
-Patients with a history of active or recurrent herpes zoster.
-Patients with a history of or prior articular or prosthetic joint infection.
-Prior or current history of malignancy.
-Patients who have had surgery within 4 weeks of screening or planned
surgery during study.
-Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method