Systemic Lupus Erythematosus
Conditions
Interventions
Telitacicept group:Injection of Telitacicept
Control group:Conventional therapy
Sponsors
Xuzhou NO.1 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years, female. 2. Meet the diagnostic criteria for SLE: the American College of Rheumatology (ACR)-1997 classification criteria, or 2019 EULAR/ ACR classification criteria for SLE. 3. SLE disease activity index (SLEDAI) score >=8 points while screening. If positive anti-dsDNA antibody and complement C3 and/or C4 below normal exists, the score for clinical symptoms should be >=6 points. 4. No use of other immunosuppressive agents or small-molecule monoclonal antibodies (for newly diagnosed patients only). 5. Volunteer to participate in this study, and provide written informed consent. 6. Regular hours and diet.
Exclusion criteria
Exclusion criteria: 1. Other comorbidities (diabetes, hyperlipidemia and other metabolic diseases) or critical basic diseases (acute coronary syndrome, chronic renal failure, tumors, etc.). 2. Combined with infectious diseases (respiratory tract infections, digestive tract infections, urinary tract infections, etc.), neoplasms, and other connective tissue diseases. 3. Combined with other autoimmune disease (rheumatoid arthritis, dermatomyositis, polymyositis, scleroderma, inflammatory bowel disease, etc.). 4. Combined with allergic diseases such as allergy and asthma. 5. Major gastrointestinal surgery 3 months prior to enrollment. 6. Use of antibiotics probiotics or prebiotics 3 months prior to enrollment. 7. Gestation period or lactation. 8. There are other reasons judged by investigators for ineligibility to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory data;Fecal IgA level;Fecal 16s rRNA sequencing; | — |
Countries
China
Contacts
Public ContactRen Yile
Xuzhou NO.1 People's Hospital
Outcome results
None listed