Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00524381
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : February 23, 2010
Information provided by:
Bispebjerg Hospital

August 30, 2007
September 3, 2007
February 23, 2010
August 2007
July 2009   (Final data collection date for primary outcome measure)
Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT00524381 on Archive Site
  • Plasma concentrations of various cytokines, chemokines, and adipokines [ Time Frame: 14 days ]
  • Quantitative use of analgesics [ Time Frame: 14 days ]
  • Insulin sensitivity (HOMA) [ Time Frame: 14 days ]
  • Plasma concentrations of various cytokines, chemokines, and adipokines. [ Time Frame: 14 days ]
  • Quantitative use of analgesics. [ Time Frame: 14 days ]
  • Insulin sensitivity (HOMA). [ Time Frame: 14 days ]
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Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polymyalgia Rheumatica
  • Drug: Etanercept (Enbrel)
    TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
  • Drug: Sodium chloride (placebo)
    NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2009
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Professor Henrik Galbo, Department of Rheumatology, Bispebjerg Hospital
Bispebjerg Hospital
Not Provided
Study Director: Henrik Galbo, Professor Bispebjerg Hospital, Department of Rheumatology
Bispebjerg Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP