100
Participants
Start Date
July 25, 2025
Primary Completion Date
December 25, 2025
Study Completion Date
December 25, 2025
Methylprednisolone (Corticosteroid)
In addition to conventional treatment (methyl-40mg or less /d), the treatment group also received hydroxychloroquine (100mg-200mg each time twice a day), and thalidomide (50mg-100mg each time once a day) could be added as appropriate.
Immunosuppressant other than CYC
The control group only received conventional treatment (methyl 40 mg/d or less), and other traditional immunosuppressants (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, motecophenol ester, hydroxychloroquine, tripterine, methotrexate and sulazazopyridine, etc.). No more than 3 types of immunosuppressant should be added during the whole treatment period, and the dose should not exceed 30% from the baseline period)
Telitacicept Freeze-dried powder Injection 80mg
Telitacicept is a TACI-Fc fusion protein, a type of drug used to treat autoimmune diseases. It works by targeting two key proteins, BLyS and APRIL, which are involved in the development and function of B cells, a type of white blood cell. By blocking these proteins, telitacicept can help to reduce B cell activity and suppress the immune system's overactivity in autoimmune diseases. Subcutaneous injection dose ranges from 80mg once a week to 160mg once a week.
Cyclophosphamide (CYC)
Cyclophosphamide iv injection is used for severe complications of systemic lupus erythematosus 400mg twice a week
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan
Wuhan Central Hospital
OTHER
Wuhan Hospital of Traditional Chinese Medicine
OTHER
Tongji Hospital
OTHER