Overview

Principal investigator

Hanna Zembrzuska
Internal Medicine

Eligibility criteria

Inclusion Criteria:
*  Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria
*  Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg/d prednisone)
*  Participants must be willing and able to take prednisone of 15 mg/day at randomization
*  Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:
*  Diagnosis of Giant Cell Arteritis (GCA)
*  Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia
*  Inadequately treated hypothyroidism
*  Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster
*  Patients with uncontrolled diabetes mellitus (HbA1c ≥9%)
*  Immunosuppressive therapies including systemic corticosteroids
*  Malignancy
*  Organ transplant recipient The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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For Referring Providers

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Contact the study coordinator

Jocoa Kerschen
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