Systemic Sclerosis
Conditions
Interventions
Experimental group:JAK inhibitors+ Methotrexate
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 18-75 years old. (2) The diagnosis meet 1980 American College of Rheumatology (ACR) SSc classification criteria or 2013 ACR/EULAR SSc classification criteria. (3) The patient has not received immunosuppressive agents, biological agents and small molecule targeted drugs within 4 weeks; if oral glucocorticoids are usedprednisone dose must be stabilized to a dose equivalent to =10 mg/day for at least 4 weeks prior to the first dose of study drug. If glucocorticoids are not used, it should not be taken for at least 2 weeks before enrollment. After enrollment, the dose is allowed to be reduced, and it is determined according to the needs of the disease. (4) Female and male subjects of childbearing age must use appropriate contraceptive measures during the study period and 6 months after the last study medication. Female subjects of childbearing age must have a negative pregnancy test. (5) There is no evidence or history of untreated or insufficiently treated active or latent tuberculosis (TB) infection; if T cell spot test and interferon gamma release test for tuberculosis infection are positive but active tuberculosis can be excludedprophylactic anti-tuberculosis treatment was given according to the situation. (6) Laboratory examination criteria: hemoglobin =85g/L; WBC leukocytes =3.0×10^9/L; platelets =100×10^9/L; serum alanine aminotransferase and aspartate aminotransferase do not exceed 2 times the upper limit of normal; serum creatinine does not exceed 1.5mg/dL (133umol/L); (7) The patient has the ability to comply with the entire research procedure, the ability to communicate meaningfully with the researcher, and the ability to provide written informed consent. (8) Agree to sign the informed consent form, which must be signed before enrollment; (9) Agree to stop adjuvant therapy such as traditional Chinese medicine acupuncture before 2 weeks of enrollment and the whole study period.
Exclusion criteria
Exclusion criteria: ? Recurrent or chronic infection, including AIDS, hepatitis B, hepatitis C, TB infection and herpes zoster, etc.; positive for hepatitis B surface antigen, positive for hepatitis C antibody or positive for human immunodeficiency virus antibody. ?With other connective tissue diseases, including but not limited to overlap syndrome, mixed connective tissue disease, morphea or linear scleroderma, systemic lupus erythematosus, psoriatic arthritis, ankylosing spine Inflammation and serious diseases of the heart, lungs, kidneys and other organs or gastrointestinal ulcers. ? Current history of malignant tumor or malignant tumor. Diseases of severe, progressive or uncontrolled heart, lung, kidney, liver, blood, gastrointestinal, endocrine, neurological, mental or brain. ? Serum creatinine>200 µmol/L or glomerular Estimated filtration rate [GFR] < 40 mL/min/1.73 m2; ? Contraindications to MTX treatment, such as aspartate aminotransferase (AST) or or alanine aminotransferase (ALT) or bilirubin levels = normal 3 times the upper limit of the value and confirmed by repeat testing. ? Received DMARDs (such as methotrexate, leflunomide, sulfasalazine, gold preparations, azathioprine, cyclosporine, mycophenolate mofetil, ilamol) within the past 4 weeks before the first dose Germany, etc.) or tripterygium glycosides. ? Have used biological agents before randomization, including (but not limited to) Yisaipu, Qiangke, Ambrio, Infliximab, Etanercept, Adalimumab, Pescezumab, tocilizumab and rituximab. ? Poor compliance, unable to comply with visit schedules, treatment plans, laboratory tests and other research procedures. ? Women or men who became pregnant during the study period or had fertility requirements. ? Participation in other drug trials during the research period or reasons for other researchers who think it is not appropriate to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rodnan Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAQ-DI;Overall evaluation of diseases (VAS); | — |
Countries
China
Contacts
Public ContactQIAN WANG
Beijing Hospital
Outcome results
None listed