Infliximab in the treatment of Polymyalgia Rheumatica

INTERVENTION: Patients will be randomly assigned to receive infusions of infliximab 3 mg/Kg, respectively, at weeks 0, 2, 6, 14, 22. All patients will be treated with oral prednisone according to a fixed tapering protocol with a starting daily dosage of 15 mg tapered to 0 in 16 weeks. Prednisone dosage will be increased/restarted if flare‐ups occurred. Patients will be evaluated every 4 weeks during the 52 week follow‐up period. CONDITION: Polymyalgia rheumatica PRIMARY OUTCOME: The predefined primary efficacy end point is the proportion of relapse/recurrence free patients SECONDARY OUTCOME: The proportion of relapse/recurrence free patients The cumulative dose of prednisone The duration of prednisone therapy The number of patients with adverse events The proportion of patients no longer taking steroids The total number of relapses or recurrences INCLUSION CRITERIA: Consecutive adult patients who satisfy Healey’s criteria for the diagnosis of PMR will be included in the study.