NCT00524381

Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polymyalgia Rheumatica

Interventions

Type	Name	Description
DRUG	Etanercept (Enbrel)	TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
DRUG	Sodium chloride (placebo)	NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2007-09-03
• Last updated: 2010-02-23

Locations

1 site across 1 country: Denmark