Clinical Trial: Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Brief 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.

Detailed Summary:
Sponsor: Bnai Zion Medical Center

Current Primary Outcome: a total dose of glucocorticoids used in the course of the disease [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bnai Zion Medical Center

Dates:
Date Received: September 15, 2009
Date Started: March 2010
Date Completion: March 2012
Last Updated: July 18, 2010
Last Verified: July 2010