Polymyalgia rheumatica. MedDRA version: 8.1 Level: LLT Classification code 10036099 Term: Polymyalgia rheumatica
Conditions
Interventions
Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243690
Concentration unit: mg milligram(s)
Concentration number: 25
Sponsors
Department of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To elucidate the disease mechanisms and to improve the treatment of polymyalgia rheumatica. The effect of TNF alpha inhibition on the clinical course of the disease activity will be studied.;Secondary Objective: ;Primary end point(s): - Clinical and paraclinical data (including the use of analgesics to patients treated with Etanercept and placebo, respectively). | — |
Countries
Denmark
Outcome results
None listed