Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
Status:
Unknown status
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
The study will examine the efficacy of a single intramuscular injection of betamethasone
dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml)
as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be
randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution)
immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy,
starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the
disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome
measures: the total cumulative dose of glucocorticosteroids and disease duration.