Rheumatoid Arthritis
Conditions
Interventions
Telitacicept:Telitacicept 160mg qw ih*12 weeks
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Fulfill the classification criteria of the 2010 ACR/ EULAR 2. Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks 3. For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent 18 years and = 1.0 × 10^9/L, platelet count >= 100 × 10^9/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate > 60 ml/min; (3) Voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects with other autoimmune diseases 2. Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study 3. Subjects with a history of malignancy (or less than 5 years since clinical remission) 4. Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period 5. Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study 6. Subjects allergic to talizumab or any excipients 7. Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study 8. Subjects with active hepatitis or a history of severe liver disease at screening 9. Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication 10. Subjects with other conditions deemed unsuitable for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American College of Rheumatology, ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR50;ACR70;Clinical disease activity index, CDAI;Simple disease activity index, SDAI;Disease activity score, DAS 28;Change in the dose of glucocorticoids ; | — |
Countries
China
Contacts
Public ContactXinping Tian
Peking Union Medical College Hospital
Outcome results
None listed