Systemic Sclerosis
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.All patients voluntarily participated in the study and provided written informed consent. 2.Age 18 to 70 years, both males and females. 3.Meeting the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis (SSc). 4.Patients must be in the active phase of systemic sclerosis (SSc), defined by a EUSTAR Activity Index (EUSTAR-AI) score of >=2.5. 5.Patients must exhibit evidence of inflammation, defined as either CRP>=5 mg/L or IL-6 levels above the normal range, with other potential causes (e.g., infection, malignancy) ruled out. 6.Use of oral corticosteroids (=2 weeks prior to and including the baseline visit. 7.If methotrexate (>=7.5 mg/week) or mycophenolate mofetil (>=1.0 g/day) is used as oral background therapy, a stable dose must have been maintained for at least 12 weeks. Concomitant use of cyclophosphamide as background therapy is permitted at a dose of 500 mg to 1000 mg/(m^2·month), provided that a stable dose has been maintained for more than 12 weeks. 8.Use of PDE-5 inhibitors, endothelin receptor antagonists, or other pulmonary arterial hypertension (PAH) medications, as well as antifibrotic agents (e.g., pirfenidone, nintedanib), is permitted for the treatment of Raynaud's phenomenon, digital ulcers, PAH, or pulmonary fibrosis.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergic predisposition or severe hypersensitivity or anaphylactic reactions to tocilizumab are excluded. 2.Patients with active infectious diseases (including but not limited to tuberculosis (TB), viral hepatitis, HIV, and syphilis) or a history of infections requiring hospitalization are excluded. 3.Patients with abnormal liver function tests, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2.0 times the upper limit of normal (ULN), or bilirubin levels > 1.5 times ULN, are excluded. 4.Patients with neutropenia (absolute neutrophil count < 1×10^9/L) or thrombocytopenia (platelet count < 100×10^9/L) are excluded. 5.Patients with a history of diverticulitis, inflammatory bowel disease, or gastrointestinal perforation are excluded. 6.Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiovascular, neurologic, or cerebral diseases are excluded. Additionally, patients whom the investigator deems to be at unacceptable risk due to study participation are excluded. 7.Patients with other coexisting autoimmune diseases are excluded. 8.Patients who have undergone tocilizumab therapy within the past 12 weeks are excluded. 9.Pregnant or breastfeeding women are excluded. 10.Patients who have been enrolled in clinical trials within the last 3 months or are currently participating in any clinical trial are excluded. 11.Patients who are otherwise considered unsuitable for participation by the investigator are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The EUSTAR-AI < 2.5 percentage of Pantients; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRSS score;DAS28-CRP score; DAS28-ESR score;Forced vital capacity as a percentage of predicted;Carbon monoxide diffuse capacity;Markers of inflammation; | — |
Countries
China
Contacts
Public ContactSun Li
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed