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

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

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

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)

Resource links provided by NLM:

MedlinePlus related topics: Polymyalgia Rheumatica

Drug Information available for: Etanercept Sodium chloride

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
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: Malene Jull, MD

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Study Director:

Henrik Galbo, Professor

Bispebjerg Hospital, Department of Rheumatology

More Information

No publications provided

Responsible Party:	Department of Rheumatology, Bispebjerg Hospital ( Professor Henrik Galbo )
Study ID Numbers:	PMR-ENBREL-1
Study First Received:	August 30, 2007
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00524381 History of Changes
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:

Anti-Inflammatory Agents
Immunologic Factors
Brain Diseases
TNFR-Fc fusion protein
Cerebrovascular Disorders
Horton's Disease
Temporal Arteritis
Musculoskeletal Diseases
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Arteritis
Analgesics
Autoimmune Diseases of the Nervous System

Autoimmune Diseases
Vasculitis
Skin Diseases
Vascular Diseases
Central Nervous System Diseases
Rheumatic Diseases
Immunosuppressive Agents
Muscular Diseases
Giant Cell Arteritis
Polymyalgia Rheumatica
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Vasculitis, Central Nervous System
Brain Diseases
TNFR-Fc fusion protein
Cerebrovascular Disorders
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Connective Tissue Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Arteritis
Analgesics

Autoimmune Diseases of the Nervous System
Skin Diseases, Vascular
Vasculitis
Autoimmune Diseases
Skin Diseases
Immune System Diseases
Nervous System Diseases
Gastrointestinal Agents
Vascular Diseases
Central Nervous System Diseases
Rheumatic Diseases
Immunosuppressive Agents
Pharmacologic Actions
Muscular Diseases
Giant Cell Arteritis

ClinicalTrials.gov processed this record on July 06, 2009