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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
  Purpose

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.


Condition Intervention Phase
Polymyalgia Rheumatica
 Drug: Etanercept (Enbrel)
Drug: Sodium chloride (placebo)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524381

Locations
Denmark
Bispebjerg Hospital, Department of Rheumatology
Copenhagen NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Study Director: Henrik Galbo, Professor Bispebjerg Hospital, Department of Rheumatology
  More Information

No publications provided by Bispebjerg Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Henrik Galbo, Department of Rheumatology, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00524381     History of Changes
Other Study ID Numbers: PMR-ENBREL-1
Study First Received: August 30, 2007
Last Updated: February 22, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Arteritis
Vascular Diseases
Cardiovascular Diseases
 Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013