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


Phase 3
50 Years
N/A
Not Enrolling
Both
Polymyalgia Rheumatica

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Polymyalgia rheumatica activity score (PMR-AS)

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Henrik Galbo, Professor

Investigator Role:

Study Director

Investigator Affiliation:

Bispebjerg Hospital, Department of Rheumatology

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

PMR-ENBREL-1

NCT ID:

NCT00524381

Start Date:

August 2007

Completion Date:

September 2009

Related Keywords:

  • Polymyalgia Rheumatica
  • Polymyalgia Rheumatica
  • Giant Cell Arteritis

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