Recurrent/Refractory Pediatric Systemic Lupus Erythematosus, Juvenile Dermatomyositis, Sjogren's Syndrome, Systemic Sclerosis
Conditions
Interventions
Experimental group:Teclistamab
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Diagnostic criteria: Diagnosed as an autoimmune disease according to internationally recognized classification standards (including systemic lupus erythematosus, systemic sclerosis, juvenile dermatomyositis, Sjögren's syndrome); 2.Evidence of B cell/plasma cell involvement: characteristic autoantibodies were detected, including ANA, anti-dsDNA, anti-Jo-1, anti-MDA5, anti-PL-7, anti-SSA, anti-SSB,; 3.Evidence of disease activity: Active disease was present at enrollment (based on disease activity assessment scales and corresponding standard evaluations), accompanied by clinical or laboratory evidence suggesting persistent immune activation; 4.Evidence of recurrent/refractory disease: Previous poor efficacy, having used at least three DMARDs with poor treatment response, including: (1) Conventional synthetic DMARDs (such as cyclophosphamide, methotrexate, leflunomide, etc.); (2) Biologics (such as rituximab, belimumab); (3) Targeted synthetic DMARDs (such as JAK inhibitors); 5.Age and weight restrictions: weight >=35kg, age 12-17 years at screening; 6.Guardians and patients provide written informed consent; 7.Follow-up accessibility: follow-up can be conducted on schedule;
Exclusion criteria
Exclusion criteria: 1.Presence of active infectious diseases: presence of active tuberculosis, EB, CMV; 2.Presence of neoplastic diseases: evidence of past and current neoplastic diseases; 3.Presence of neurological diseases: epilepsy, organic brain disease, cerebrovascular events, cranial nerve disorders; 4.Presence of serious cardiovascular system disease: NYHA cardiac function classification >= Class II; 5.Severe liver and kidney dysfunction: liver function (ALT/AST) exceeding twice the upper limit of normal or abnormal kidney function; 6.History of allergies: Individuals who have previously experienced anaphylactic shock, severe infusion reactions, or other serious hypersensitivity reactions when receiving any monoclonal antibody or biologic agent. 7.Those with poor past compliance or unwilling to undergo long-term follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Characteristics of Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rodnan Skin Score;ESSDAI Score;Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; | — |
Countries
China
Contacts
Public ContactHongmei Song
Peking Union Medical College Hospital
Outcome results
None listed