Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Polymyalgia Rheumatica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524381
• Other study ID #: PMR-ENBREL-1
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2007
• Last updated: February 22, 2010
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2010
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Etanercept (Enbrel)
TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
• Sodium chloride (placebo)
NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Rheumatology	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymyalgia rheumatica activity score (PMR-AS)		14 days	No
Secondary	Plasma concentrations of various cytokines, chemokines, and adipokines		14 days	No
Secondary	Quantitative use of analgesics		14 days	No
Secondary	Insulin sensitivity (HOMA)		14 days	No