Polymyalgia Rheumatica
Conditions
Keywords
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.
Interventions
DRUGBetamethasone
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
DRUGisotonic sodium chloride solution (placebo)
4 ml intramuscular
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of polymyalgia rheumatica
Exclusion criteria
* decompensated diabetes mellitus * decompensated arterial hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a total dose of glucocorticoids used in the course of the disease | 12 months |
Countries
Israel
Contacts
Primary ContactGleb Slobodin, MD
Outcome results
None listed