Rheumatoid Arthritis
Conditions
Interventions
Ivarmacitinib Tablet Group:Treatment with Ivarmacitinib Tablets
Sponsors
Nanjing DrumTower Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the Informed Consent Form prior to any study-related procedures, demonstrate understanding of the study procedures and methods, and commit to strict adherence to the clinical protocol; 2. Aged 18–75 years (inclusive) at the time of signing informed consent, regardless of gender; 3. Meet the 1987 ACR RA diagnostic criteria or the 2010 ACR/EULAR RA classification criteria, with an ACR functional class I–III at screening; 4. Moderate-to-severe active RA at screening, defined as:Tender Joint Count (TJC) >=6 or Swollen Joint Count (SJC) >=6 (based on 68/66 joints), and Erythrocyte Sedimentation Rate (ESR) >28 mm/h or C-reactive Protein (CRP)/high-sensitivity CRP (hsCRP) >5 mg/L; 5. Female subjects of childbearing potential must:Have a negative serum pregnancy test within 7 days prior to the first dose,Be non-lactating, Agree to use effective contraception during the trial and for 1 month after the last dose of Emasitinib Tablets;Male subjects with partners of childbearing potential must agree to use reliable contraception from signing informed consent until 1 month after the last dose, and refrain from sperm donation during this period.
Exclusion criteria
Exclusion criteria: 1. Prior primary failure to JAK inhibitors (e.g., tofacitinib, upadacitinib, baricitinib, filgotinib, deucravacitinib, including topical agents) after standard treatment courses; 2. Presence of active primary fibromyalgia or other conditions affecting RA symptom assessment, as confirmed by the investigator; 3. Lactating or pregnant women, or subjects of childbearing potential unwilling to use effective contraception during the trial and for 1 month post-last-dose; 4. Uncontrolled infections, e.g.:HBV carriers with hepatic dysfunction (AST/ALT >=3×ULN or bilirubin >=1.5×ULN),History of latent/active tuberculosis without sufficient anti-TB therapy; 5. eGFR <60 mL/min/1.73 m² (calculated by MDRD or other validated methods); 6. Moderate-to-severe congestive heart failure (NYHA class III/IV) or cardiovascular events requiring hospitalization within 6 months (e.g., PTCA, CABG, cerebral/subarachnoid hemorrhage); 7. Malignancy history (except adequately treated non-metastatic basal/squamous cell skin cancer or carcinoma in situ of the cervix); 8. Participation in other clinical trials within 30 days before screening; 9. Refusal to sign informed consent or inability to cooperate with medical history collection; 10. Any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology (ACR) criteria improvement of 20% (ACR20);Health Assessment Questionnaire Disability Index (HAQ-DI); | — |
Secondary
| Measure | Time frame |
|---|---|
| American College of Rheumatology (ACR) criteria improvement of 50% (ACR50);American College of Rheumatology (ACR) criteria improvement of 70% (ACR70);Clinical Disease Activity Index (CDAI) Score;Simplified Disease Activity Index (SDAI) Score;Outcome Measures in Rheumatology Clinical Trials - Rheumatoid Arthritis Magnetic Resonance Imaging Score (OMERACT-RAMRIS);Disease Activity Score 28 (DAS28) using C-reactive protein; | — |
Countries
China
Contacts
Public ContactSun Lingyun
Nanjing DrumTower Hospital of Nanjing University Medical School
Outcome results
None listed