A multicenter randomized placebo controlled treatment study of leflunomide in polymyalgia rheumatica

Phase 3

Recruiting

• Conditions: PMR; 10003816; 10013361

• Registration Number: NL-OMON46948
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 94

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

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:
• EGFR<50 ml/min
• ALT or 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 hypertension14. Major surgery or hospitalization within 3 month
prior to screening15. Any medical condition that could interfere with the
implementation or interpretation of the study or with the safety of the patient
during the study. OURS=0
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Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the time to the first relapse within the first12<br /><br>months.</p><br>