The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR). PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR. The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.
Bispebjerg Hospital, Department of Rheumatology
Copenhagen NV, Denmark
Polymyalgia rheumatica activity score (PMR-AS)
Time frame: 14 days
Plasma concentrations of various cytokines, chemokines, and adipokines
Time frame: 14 days
Quantitative use of analgesics
Time frame: 14 days
Insulin sensitivity (HOMA)
Time frame: 14 days
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