NCT00524381CompletedPhase 3
The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Polymyalgia rheumatica activity score (PMR-AS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Persons with active polymyalgia rheumatica (patients only).
- •Signed informed consent and written authorization.
Exclusion Criteria
- •Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
- •Current malignancy or history of malignancy.
- •Neuromuscular conditions.
- •Infections with systemic impact.
- •Uncontrolled diabetes mellitus.
- •Uncontrolled hypertension.
- •Current tuberculosis or history of tuberculosis.
- •Severe heart failure (NYHA class 3 and 4).
- •Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.
- •Exclusion Criteria (controls):
- •Polymyalgia rheumatica.
Outcomes
Primary Outcomes
Polymyalgia rheumatica activity score (PMR-AS)
Time Frame: 14 days
Secondary Outcomes
- Plasma concentrations of various cytokines, chemokines, and adipokines(14 days)
- Quantitative use of analgesics(14 days)
- Insulin sensitivity (HOMA)(14 days)
Investigators
Study Sites (2)
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