Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03576794
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent
2. Female or male aged ≥ 50 years
3. PMR according to the American College of Rheumatology (ACR)/European league Against Rheumatism (EULAR) 2012 PMR core (essential) classification criteria
4. Newly diagnosed PMR being on glucocorticoids for less than 4 weeks
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:
* Glomerular filtration rate \<50 ml/min
* Alanine-aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5x 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03576794
Study Brief:
Protocol Section:
NCT03576794