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:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT07266168
Eligibility Criteria:
Inclusion Criteria:
1. Age and Weight: 50-75 years old, body weight 40-80 kg.
2. Diagnosis: Confirmed diagnosis of polymyalgia rheumatica (PMR) according to the 2012 ACR/EULAR classification criteria .
3. Disease Activity: CRP-PMR-AS (C-reactive protein polymyalgia rheumatica activity score) ≥17 .
4. Glucocorticoid Use:
* Newly Diagnosed Patients: No glucocorticoid use within 12 weeks prior to enrollment.
* Relapsed Patients: No increase in glucocorticoid dosage within 2 weeks prior to enrollment, and willingness to discontinue current glucocorticoids after enrollment.
5. Compliance: Participants must understand and agree to adhere to study procedures and restrictions.
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Exclusion Criteria:
1. Allergy: Known hypersensitivity to the investigational drug or excipients (including lactose, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid).
2. Comorbidities:
* Giant cell arteritis (GCA) .
* Other diffuse connective tissue diseases (e.g., systemic lupus erythematosus), spondyloarthropathy, or active fibromyalgia .
3. Uncontrolled Chronic Conditions:
* Diabetes (HbA1c ≥8.0%) or uncontrolled hypertension (resting SBP ≥140 mmHg and/or DBP ≥90 mmHg) .
* Clinically significant ECG abnormalities (e.g., acute myocardial ischemia, myocardial infarction, severe arrhythmia, QTc \>500 ms).
4. Organ Dysfunction:
* Liver/Kidney Impairment:
* AST/ALT ≥2× upper limit of normal (ULN).
* Serum creatinine or total bilirubin ≥1.5× ULN .
5. Malignancy: History of malignancy within the past 5 years.
6. Infections:
* Active uncontrolled infections (e.g., tuberculosis, hepatitis B surface antigen (HBsAg) positive with elevated HBV-DNA, HCV, HIV, or active syphilis).
* Severe herpes zoster infection or systemic antimicrobial therapy within 2 weeks prior to randomization.
7. Reproductive Plans: Pregnancy planning within 1 year.
8. Prior Medications: Previous use of JAK inhibitors.
9. Thrombosis: History of thrombotic events.
10. Other: Any condition deemed inappropriate by the investigator for participation in this clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07266168
Study Brief:
Protocol Section:
NCT07266168