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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Polymyalgia Rheumatica
  • Age: Between 50 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects diagnosed with PMR
    2. Subjects 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
    3. Subjects are willing and able to take prednisone of 15 mg/day at randomization.
    4. Subjects must have a history of being treated for at least 8 weeks with prednisone (=10 mg/day or equivalent).
    5. Subjects 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
    6. Subjects must have ESR =30 mm/hr and/or CRP =10 mg/L associated with PMR disease activity within 12 weeks prior to screening.

You may not be eligible for this study if the following are true:

    1. Subjects with diagnosis of giant cell arteritis (GCA).
    2. Subjects with concurrent diagnosis of active fibromyalgia
    3. Subjects with concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases
    4. Subjects with concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases.
    5. Subjects who have been inadequately treated hypothyroidism
    6. Subjects who had organ transplant recipient.
    7. Subjects with therapeutic failure including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist.
    8. Subjects with unstable methotrexate (MTX) dose and/or MTX dose >15 mg/week within 3 months of baseline/li>
    9. Subjects with concurrent use of systemic CS for conditions other than PMR.
    10. Subjects who have evidence of serious, uncontrolled concomitant disease



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