Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
|ClinicalTrials.gov Identifier: NCT00524381|
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : February 23, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Polymyalgia Rheumatica||Drug: Etanercept (Enbrel) Drug: Sodium chloride (placebo)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||September 2009|
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524381
|Bispebjerg Hospital, Department of Rheumatology|
|Copenhagen NV, Denmark, DK-2400|
|Study Director:||Henrik Galbo, Professor||Bispebjerg Hospital, Department of Rheumatology|