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The effect of TNF alpha inhibition on the early clinical course of Polymyalgia Rheumatica (pilot study). - N/A

Conditions
Polymyalgia rheumatica.
MedDRA version: 8.1Level: LLTClassification code 10036099Term: Polymyalgia rheumatica
Registration Number
EUCTR2007-003009-28-DK
Lead Sponsor
Department of Rheumatology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Patients with newly diagnosed polymyalgia rheumatica.
Patients must:
- Suffer from pain and stiffness in proximal limb muscles.
- Be above 50 years of age.
- Have a ESR of more than 40 mm per hr.
- Have elevated levels of CRP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Other inflammatory diseases than polymyalgia rheumatica, including sings of giant cell arteritis, eg. headache, masseter muscle claudication, and visual disturbances.
Malignant or neuromuscular diseases, infections with systemic impact (especially tuberculosis and hepatitis), severe heart disease (NYHA class 3 and 4).

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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