LEFLUNOMIDE for Polymyalgia rheumatica

Inclusion criteria

• {"criterion_text":"- 1. Female or male aged ≥ 50 years\n- 2. PMR according to the ACR/EULAR 2012 PMR core (essential) classification criteria\n- 3. Newly diagnosed PMR being on corticosteroids glucocorticoids for less than 4 weeks"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- the time to the first relapse at 12 months","definition_or_measurement_approach":"time to first relapse during the first 12 months"}

Netherlands

Earliest CTIS Part Ii Submission Date

08-08-2024

Latest Decision Or Authorization Date

12-08-2024

Processing Time Days

4

Number Of Sites

2

Number Of Participants

94

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands