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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept (Enbrel) | Drug | TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days. | ||
| Sodium chloride (placebo) | Drug | NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Polymyalgia rheumatica activity score (PMR-AS) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of various cytokines, chemokines, and adipokines | 14 days | |
| Quantitative use of analgesics | 14 days | |
| Insulin sensitivity (HOMA) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria (controls):
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Galbo, Professor | Bispebjerg Hospital, Department of Rheumatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital, Department of Rheumatology | Copenhagen NV | DK-2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22894827 | Derived | Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017. | |
| 20854662 | Derived | Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20. |
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| ID | Term |
|---|---|
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 14 days |
| D017437 | Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |