Clinical Trial: Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
Brief 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.
Detailed Summary:
Sponsor: Bispebjerg Hospital
Current Primary Outcome: Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- 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 ]
Information By: Bispebjerg Hospital
Dates:
Date Received: August 30, 2007
Date Started: August 2007
Date Completion:
Last Updated: February 22, 2010
Last Verified: February 2010
