Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
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.
|Polymyalgia Rheumatica||Drug: Etanercept (Enbrel) Drug: Sodium chloride (placebo)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)|
- 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 ]
|Study Start Date:||August 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Drug: Etanercept (Enbrel)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524381
|Bispebjerg Hospital, Department of Rheumatology|
|Copenhagen NV, Denmark, DK-2400|
|Study Director:||Henrik Galbo, Professor||Bispebjerg Hospital, Department of Rheumatology|