ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00524381
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:
Bispebjerg Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: Etanercept (Enbrel) Drug: Sodium chloride (placebo) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
Study Start Date : August 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources


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.


Primary Outcome Measures :
  1. Polymyalgia rheumatica activity score (PMR-AS) [ Time Frame: 14 days ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 3, 2007    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: February 2010

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
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents