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Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
This study is ongoing, but not recruiting participants.
Study NCT00524381   Information provided by Bispebjerg Hospital
First Received: August 30, 2007   Last Updated: July 9, 2009   History of Changes

August 30, 2007
July 9, 2009
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 ]
 
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Polymyalgia Rheumatica
  • Drug: Etanercept (Enbrel)
  • Drug: Sodium chloride (placebo)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
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
Professor Henrik Galbo, Department of Rheumatology, Bispebjerg Hospital
PMR-ENBREL-1
Bispebjerg Hospital
 
Study Director: Henrik Galbo, Professor Bispebjerg Hospital, Department of Rheumatology
Bispebjerg Hospital
July 2009

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