systemicsclerosis
Conditions
Interventions
Experimental group:the combination of ivarmacitinib and conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs)
Control group:conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs)
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meets the classification criteria proposed by the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) for SSc; 2. Age range: 18-70 years old; 3. Disease duration = 5 years (starting from the first non-Raynaud's phenomenon manifestation); at the screening stage, the modified Rodman Skin Score (mRSS) is = 10 and less than 30; 4. No new types of glucocorticoids and/or csDMARDs (Conventional Synthetic Disease-Modifying Antirheumatic Drugs) were added within 3 months, and the dosage did not increase within 1 month; 5. The patient understands the purpose, process and significance of this study, voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Within the past 3 months, there has been a severe bacterial infection or chronic bacterial infection, infectious diseases, including AIDS, hepatitis B, hepatitis C, TB infection, and herpes zoster, etc.; positive hepatitis B surface antigen, positive hepatitis C antibody or positive human immunodeficiency virus antibody; evidence or history of active or latent tuberculosis (TB) infection that has not been treated or has been inadequately treated; 2. Before screening, there were new or aggravated clinical symptoms, and the patient was judged by the investigator to require hospitalization for treatment: ? Patients with new or aggravated clinical symptoms within 6 months of myocardial infarction, stroke, renal crisis, severe hypertension (=160/100 mmHg) that was not controlled; ? Patients with new or aggravated unstable ischemic heart disease, uncontrolled arrhythmia, heart failure, New York Heart Association III/IV stage or echocardiography indicating left ventricular ejection fraction 35 mmHg, forced vital capacity (FVC) < 40%, carbon monoxide diffusion capacity (DLCO) < 30%; 5. In addition to SSc, has other rheumatic or connective tissue diseases, including but not limited to overlap syndrome, mixed connective tissue disease, lichenoid dermatosis or linear scleroderma, systemic lupus erythematosus, psoriatic arthritis, ankylosing spondylitis, and symptoms or signs of severe, progressive or uncontrolled heart, lung, kidney, liver, blood, gastrointestinal, endocrine, nervous, mental or brain diseases; 6. Has used biologic anti-rheumatic drugs (bDMARDs) or targeted anti-rheumatic drugs (tsDMARDs), plasma exchange or extracorporeal light exchange therapy within 3 months; received CD20 monoclonal antibody treatment within 1 year; 7. Has received stem cell-based drugs within 1 year or is currently undergoing stem cell-based drug treatment; 8. Had any history of malignant tumors within the past 5 years before enrollment; 9. Has a history of thrombosis (including myocardial infarction, stroke and transient ischemic attack) within 12 months; 10. Pregnant women, lactating women, or women who are unwilling or unable to take contraceptive measures during medication; 11. Patients participating in other clinical studies. 12. Other circumstances where participants should not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved Rodman skin rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate;Severe adverse event rate; | — |
Countries
China
Contacts
Public ContactQiang Shu
Qilu Hospital of Shandong University
Outcome results
None listed