Treatment with leflunomide in patients with polymyalgia rheumatica

Phase 1

Active, not recruiting

• Conditions: Polymyalgia Rheumatica; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001079-22-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Female or male aged = 50 years
2. PMR according to the ACR/EULAR 2012 PMR core (essential) classification criteria
3. Newly diagnosed PMR being on corticosteroids glucocorticoids for less than 4 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified