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Completed

NCT Number: NCT00524381

Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

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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Key information

Conditions

Polymyalgia Rheumatica Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bispebjerg Hospital, Department of Rheumatology

Copenhagen NV, DK-2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Polymyalgia rheumatica activity score (PMR-AS)

    Time frame: 14 days

Secondary outcomes

  1. Plasma concentrations of various cytokines, chemokines, and adipokines

    Time frame: 14 days

  2. Quantitative use of analgesics

    Time frame: 14 days

  3. Insulin sensitivity (HOMA)

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 3, 2007
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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