Treatment with leflunomide in patients with polymyalgia rheumatica

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• 1. Presence of any other connective tissue disease, including vasculitis/giant-cell arteritis 2. PMR on glucocorticoidsglucocorticosteroids for >4 week or >25 mg/day 3. History of alcohol or drug abuse or current alcohol or drug abuse 4. Transplanted organ (except corneal transplant performed more than 3 months prior to screening) 5. Evidence (as assessed by the investigator) of active infection, presence of hepatitis B surface antigen or hepatitis C antibody in blood, HIV positivity. 6. Malignancy within 5 years prior to screening, except for nonmelanoma skin cancer 7. Exposure to DMARD/biological in the last 5 years 8. Pain syndromes, e.g. fibromyalgia, drug-induced myalgia 9. Active thyroid disease 10. Neurological diseases, e.g. Parkinson's disease 11. Contraindications for leflunomide 12. Laboratory abnormalities: renal or hepatic impairment, anemia and significant cytopenia 13. Uncontrolled or poorly controlled hypertension 14. Major surgery or hospitalization within 3 month prior to screening