A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica
- Conditions
- PMR10003816
- Registration Number
- NL-OMON45962
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
-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.
-Diagnosis of giant cell arteritis.
-Diagnosis of active fibromyalgia.
-Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases. -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 (as specified in protocol).
-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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients achieving sustained remission at Week 52</p><br>
- Secondary Outcome Measures
Name Time Method <p>Summary of the components of sustained remission composite measure at week 52<br /><br>Total cumulative corticosteroid (including prednisone) dose over 52 weeks<br /><br>Time to first polymyalgia rheumatica (PMR) flare<br /><br>Changes from baseline in the glucocoritcoid toxicity index and its components<br /><br>up to week 52<br /><br>Number of adverse events up to week 58<br /><br>Pharmacokinetic: Serum concentrations of sarilumab up to week 58</p><br>