Systemic Sclerosis
Conditions
Interventions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. SSc meets 2013 American College of Rheumatology/European League Against Rheumatism classification criteria; 2. 2001 LeRoy and Medsger defined dcSSc; 3. Disease duration = 10 and = 2 weeks prior to, including the baseline visit; 6. Immunosuppressive drugs are allowed as oral therapy and should be used at a stable dose for at least 12 weeks; 7. The use of PDE-5 inhibitors as oral agents for the treatment of Raynaud's and digital ulcers is allowed; 8. Age >= 18 years and <= 70 years; 9. Able to provide informed consent. Must have read and understood the site's Institutional Review Board (IRB)/Ethics Review Board (ERB) approved informed consent and provided written informed consent.
Exclusion criteria
Exclusion criteria: 1.Rheumatic diseases other than dcSSc; fibromyalgia, Sj gren's syndrome, and scleroderma-related myopathy may be included; 2.Localized cutaneous SSc or scleroderma without cutaneous sclerosis; 3.Major trauma or major surgery (including joint surgery) within 8 weeks before baseline, or major surgery is required during the study, which will bring unacceptable risk to the patients in the opinion of the investigator; 4.Any infected ulcer at screening; 5.Subject has any serious bacterial infection (except those treated with antibiotics and recovered) within the past 3 months, or any chronic bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, or bronchiectasis); 6.Oral corticosteroids > 10 mg/day prednisone or equivalent; 7.Anti-CD20 therapy 6 months prior to baseline; 8.Hydroxychloroquine > 400 mg/day, methotrexate > 25 mg/week, D-penicillamine > 1000 mg/day, Motilix > 2 g/day * Subjects may be treated with a combination of hydroxychloroquine and methotrexate or a combination of hydroxychloroquine and Motilix and must have been on a stable dose for at least 3 months prior to the baseline visit 9.a. Biologic therapy for an immune disorder such as etanercept, infliximab, certolizumab pegol, adalimumab, golimumab, tocilizumab, abatacept, ustekinizumab, secukinumab, or anakinra.12. Received belimumab or anifrolumab (or other anti-IFN therapy) before screening c. Received rituximab, any other B-cell depletion therapy, or intravenous immunoglobulin (IVIg) d. Received JAK inhibitors 30 mmHg by right heart catheterization, requiring subcutaneous or intravenous prostacyclin or concomitant use of oral PAH therapy; 14.Subjects at risk for tuberculosis (TB) a.Specifically excluded from this study were participants with a history of active TB within the past 3 years, even if they had received treatment; a history of active TB for more than 3 years, unless there was documented adequate duration and type of prior anti-TB treatment; current clinical, radiographic, or laboratory evidence of active TB; and (TB results 30 minutes prior to Screening were to be accepted and not repeated. B. latent TB at screening or within 30 days prior to screening, history of QuantiFERONGold test, negative chest x-ray and asymptomatic or no risk factors, inclusion with concurrent tuberculosis prophylaxis c.QuantiFERON indeterminate, twice indeterminate for prophylaxis of latent TB. 15.Hepatitis B HBV-DNA test positive Patients with hepatitis B virus (HBV) infection, currently receiving anti-HBV treatment and HBV-DNA negative can be enrolled, HBV-DNA will be monitored during the study. 16.Hepatitis C test positive Patients with hepatitis C virus (HCV) infection (hepatitis C antibody positive and HCV ribonucleic acid [RNA] positive) Note: Patients with documented previous HCV infection who are anti-HCV treatment and are RNA negative can be enrolled. 17.Current or recent history of uncontrolled clinically significant renal, hepatic, hematolo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology Composite Response Index in Systemic Sclerosis, ACR CRISS;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rodnan skin score, mRSS;Forced vital capacity, FVC; | — |
Countries
China
Contacts
Public ContactYu Xue
Huashan Hospital, Fudan University
Outcome results
None listed