Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Phase 3

Completed

• Conditions: Polymyalgia Rheumatica

• Registration Number: NCT00524381
• Lead Sponsor: Bispebjerg Hospital

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 Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-09-03
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-22
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Polymyalgia rheumatica activity score (PMR-AS)	14 days

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of various cytokines, chemokines, and adipokines	14 days
Quantitative use of analgesics	14 days
Insulin sensitivity (HOMA)	14 days

Trial Locations

Locations (1)

Bispebjerg Hospital, Department of Rheumatology; 🇩🇰 Copenhagen NV, Denmark