Systemic sclerosis
Conditions
Interventions
Experimental group:Add telitacicept(160mg qw ih) to patients with the stable background immunosuppressive therapy
Sponsors
Ningbo Medical Center Lihuili Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Fulfilled the American College of Rheumatology (ACR) /the European League Against Rheumatism(EULAR) 2013 criteria for SSc. (2) Received the stable background immunosuppressive therapy over 24 weeks(mycophenolate mofetil=1.0g/day,or mycophenol sodium=0.72g/day,or Cyclophosphamide=0.5g/m2 body surface area/month,or tacrolimus=1.0mg/day,or amethopterin=10mg/week,or thunder god vine=40mg/day,or azathioprine=50mg/day), and had a baseline MRSS of =10. (3) Age >18 years and <70 years. (4) Low-dose prednisone(=7.5mg/day) was allowed,but the dose should be stable over 12 weeks before the trial.
Exclusion criteria
Exclusion criteria: (1) The Carbon monoxide diffusing capacity (DLCO)=30% (2) The Left ventricular ejection fraction assessed by echocardiography =40% (3) Received B-cell-targeted therapy or plasmapheresis within 6 months (4) Had another autoimmune disease, or had severe and uncontrolled comorbidities, infections, immunodeficiencies, cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the modified Rodnan skin score(MRSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| FVC%;Pulmonary fibrosis score;Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI) ;DAS-28 ESR/CRP score; 6-minute walking test (6MWT);NYHA;capillaroscopic skin ulcer risk index;University of California, Los Angeles, Scleroderma Clinical Trials Consortium Gastrointestinal Scale(UCLA SCTC GIT) 2.0;PGA;HAQ-DI;the MOS item short from health survey(SF-36);B-cell activation factor(BAFF);proliferation-inducing ligand(APRIL);lymphocyte subpopulation;DLCO%; | — |
Countries
China
Contacts
Public ContactJin Zhang
Ningbo Medical Center Lihuili Hospital
Outcome results
None listed