Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Bispebjerg Hospital

Status and phase

Completed

Phase 3

Conditions

Polymyalgia Rheumatica

Treatments

Drug: Sodium chloride (placebo)

Drug: Etanercept (Enbrel)

Study type

Interventional

Funder types

Other

Identifiers

NCT00524381

PMR-ENBREL-1

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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):