drugset / Trial / NCT00524381

Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

NCT00524381

Phase 3 Completed 40 enrolled Bispebjerg Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2007-08
Primary completion
2009-07
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic 25 mg Subcutaneous