PMR
Conditions
Interventions
Patients in both groups will receive prednisolone 15 mg once daily and will be
randomized within 4 weeks of the start of prednisolone therapy. The
glucocorticoids will be tapered according to a shor
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Female or male aged >= 50 years 3. PMR according to the ACR/EULAR 2012 PMR core (essential) classification criteria 4. Newly diagnosed PMR being on corticosteroids 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 glucocorticosteroids 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time to the first relapse within the first12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study endpoints are: 1. Efficacy with regard to disease activity a. time to first relapse within 24 months b. proportion of patients with a relapse within 12 months and 24 months c. total number of relapses within 12 months and 24 months d. time to corticosteroid-free remission e. proportion of patients on corticosteroid-free remission at 6, 12, 18 and 24 months 2. Corticoid-sparing effect a. dose corticosteroids at 6, 12, 18 and 24 months b. cumulative dose corticosteroids at 12, 18, 24 months 3. Side-effects over the 24 months: a. the number of adverse effects b. the number of serious adverse events Other study parameters are: 1. Patient-reported outcome (Patient global VAS of PMR activity, pain, fatigue, severity of morning stiffness, sleep disturbances, patient acceptable symptom state, MHAQ, EQ-5D) 2. Other parameters: - Relationship between patient characteristics (including body weight and smoking status) and time to first relapse. - Related to biobanking: biomarkers, genetics | — |
Countries
Netherlands
Outcome results
None listed