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Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Primary Purpose

Polymyalgia Rheumatica

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Etanercept (Enbrel)

Sodium chloride (placebo)

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Bispebjerg Hospital, Department of Rheumatology

Outcomes

Primary Outcome Measures

Polymyalgia rheumatica activity score (PMR-AS)

Secondary Outcome Measures

Plasma concentrations of various cytokines, chemokines, and adipokines

Quantitative use of analgesics

Insulin sensitivity (HOMA)

Full Information

NCT ID

NCT00524381

First Posted

August 30, 2007

Last Updated

February 22, 2010

Sponsor

Bispebjerg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00524381

Brief Title

Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bispebjerg Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polymyalgia Rheumatica

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Etanercept (Enbrel)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sodium chloride (placebo)

Intervention Description

NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.

Primary Outcome Measure Information:

Title

Polymyalgia rheumatica activity score (PMR-AS)

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Plasma concentrations of various cytokines, chemokines, and adipokines

Time Frame

14 days

Title

Quantitative use of analgesics

Time Frame

14 days

Title

Insulin sensitivity (HOMA)

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Galbo, Professor

Organizational Affiliation

Bispebjerg Hospital, Department of Rheumatology

Official's Role

Study Director

Facility Information:

Facility Name

Bispebjerg Hospital, Department of Rheumatology

City

Copenhagen NV

ZIP/Postal Code

DK-2400

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22894827

Citation

Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017.

Results Reference

derived

PubMed Identifier

20854662

Citation

Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20.

Results Reference

derived

Learn more about this trial

Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

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