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

INTERVENTION: 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‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Polymyalgia rheumatica. ; MedDRA version: 8.1 Level: LLT Classification code 10036099 Term: Polymyalgia rheumatica PRIMARY OUTCOME: 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. Primary end point(s): ‐ Clinical and paraclinical data (including the use of analgesics to patients treated with Etanercept and placebo, respectively). Secondary Objective: 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