Polymyalgia Rheumatica PMR Spierreuma
Conditions
Interventions
Leflunomide
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent 2.Female or male aged ¡Ý 50 years 3.PMR according to the ACR/EULAR 2012 PMR core (essential) classification criteria 4.Newly diagnosed PMR being on glucocorticoids for less than 4 weeks
Exclusion criteria
Exclusion criteria: 1.Presence of any other connective tissue disease, including vasculitis/giant-cell arteritis 2.PMR on glucocorticoids 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 non-melanoma 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 (serious immunodeficiency, e.g. AIDS, cytopenia as defined under 12, moderate to severe kidney failure (as defined under 12), liver test abnormality (as defined under 12) 12.Laboratory abnormalities: ◦EGFR1.5x upper limit of normal ◦Platelet count <100 x 109/L (100,000/mm3) ◦Hemoglobin <85 g/L (8.5 g/dL; 5.3 mmol/L) ◦White blood cells <3.0 x 109/L (3,000/mm3)Absolute neutrophil count <2.0 x 109/L (2,000/mm3) ◦Absolute lymphocyte count <0.5 x 109/L (500/mm3) 13.Uncontrolled or poorly controlled hypertension 14.Major surgery or hospitalization within 3 month prior to screening 15.Any medical condition that could interfere with the implementation or interpretation of the study or with the safety of the patient during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PMR relaps, timepoint: first 12 months of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Efectiveness concerning disease activity a.Time till first relaps within first 24 months b.Percentage of patients with at least 1 relaps in the first 12 or 24 months c.Total relapses within the first 12 and 24 months d.Time till gucocorticoid free remission Gucocorticoid-sparing effect a.Gucocorticoid dose after 6, 12, 18 and 24 months. b.Cumulative glucocorticoid dose after 12, 18 and 24 months Safety/side-effects a.Amount of side effects b.Amount of severe side effects | — |
Contacts
Public ContactE Brouwer
University Medical Center Groningen
Outcome results
None listed