Etanercept Treatment in the Early Course of Polymyalgia Rheumatica - Full Text View

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 III

MedlinePlus related topics:

Polymyalgia Rheumatica

ChemIDplus related topics:

Sodium chloride Etanercept Chlorides Tumor Necrosis Factors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

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
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.

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

Contacts


Contact: Henrik Galbo, Professor	004540466267	hgalbo@mfi.ku.dk

Contact: Frederik Kreiner, MSc	004527292993	frederik.kreiner@gmail.com

Locations


Denmark
	Bispebjerg Hospital, Department of Rheumatology	Recruiting
	Copenhagen NV, Denmark, DK-2400
	Contact: Henrik Galbo, Professor 0045-40466267 hgalbo@mfi.ku.dk
	Contact: Frederik Kreiner, MSc 004527292993 frederik.kreiner@gmail.com
	Principal Investigator: Henrik Galbo, Professor
	Sub-Investigator: Frederik Kreiner, MSc
	Sub-Investigator: Lotte Wildau, MD

Sponsors and Collaborators

Bispebjerg Hospital

Investigators


Study Director:	Henrik Galbo, Professor	Bispebjerg Hospital, Department of Rheumatology

More Information

Responsible Party:	Department of Rheumatology, Bispebjerg Hospital ( Professor Henrik Galbo )
Study ID Numbers:	PMR-ENBREL-1
First Received:	August 30, 2007
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00524381
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Temporal arteritis

Vasculitis

Autoimmune Diseases

Skin Diseases

Vascular Diseases

Central Nervous System Diseases

Rheumatic Diseases

TNFR-Fc fusion protein

Brain Diseases

Cerebrovascular Disorders

Horton’s disease

Muscular Diseases

Musculoskeletal Diseases

Polymyalgia Rheumatica

Giant Cell Arteritis

Connective Tissue Diseases

Arteritis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Skin Diseases, Vascular

Immunologic Factors

Immune System Diseases

Nervous System Diseases

Physiological Effects of Drugs

Gastrointestinal Agents

Vasculitis, Central Nervous System

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Bispebjerg Hospital
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00524381