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Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

This study has been completed.
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00524381
First received: August 30, 2007
Last updated: February 22, 2010
Last verified: February 2010
History of Changes

August 30, 2007
February 22, 2010
August 2007
July 2009   (final data collection date for primary outcome measure)
Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ]
Complete list of historical versions of study NCT00524381 on ClinicalTrials.gov Archive Site
  • Plasma concentrations of various cytokines, chemokines, and adipokines [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Quantitative use of analgesics [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Insulin sensitivity (HOMA) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. Epub 2010 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00524381
PMR-ENBREL-1
Yes
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