polymyalgia rheumatica
Conditions
Interventions
treatment group: Ivarmacitinib
control group:Placebo
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 50 to 75 years, with a body weight of 40-80 kg; 2.Diagnosed with PMR according to the 2012 ACR/EULAR criteria; 3.CRP-based PMR Activity Score (PMR-AS) >= 17; 4.Newly diagnosed patients must not have received glucocorticoids within 12 weeks prior to enrollment; 5.Relapsed patients must not have had their glucocorticoid dose increased within 2 weeks prior to enrollment and agree to discontinue their original glucocorticoid regimen upon enrollment; 6.Participants are able to understand and are willing to voluntarily comply with the study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the investigational drug or its excipients; 2. Concurrent giant cell arteritis; or other diffuse connective tissue diseases (e.g., systemic lupus erythematosus), spondyloarthropathies, active fibromyalgia, or similar conditions; 3. Significant unstable or uncontrolled acute/chronic diseases, such as diabetes, hypertension, cardiovascular disorders, or thyroid disease; 4.Clinically significant hepatic or renal dysfunction;(The detection value of aspartate aminotransferase and alanine aminotransferase >= 2 times the upper limit of normal; Creatinine or total bilirubin >=1.5 times the upper limit of normal;) 5. History of malignancy within the past 5 years; 6. Current uncontrolled active infection; 8. Prior use of JAK inhibitors; 9. History of thrombosis; 10. History of severe herpes zoster infection; 11. Other conditions deemed by the investigator to preclude safe participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PMR-AS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory factor levels(ESR , CRP);Cytokine levels(Interleukin-6) ;Dosage of glucocorticoids; | — |
Countries
China
Contacts
Public ContactHuaxiang Wu ; Liang Zhu
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed