Antineutrophil Cytoplasmic Antibody-Associated Vasculitis
Conditions
Interventions
therapy group:add telitacicept
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged > 18 years; 2. Diagnosis of ANCA-associated vasculitis (MPA, GPA, or renal-limited vasculitis) according to the definition of the Chapel Hill Conference; 3. Positive test for either MPO-ANCA or PR3-ANCA; 4. Refractory and recurrent Antineutrophil Cytoplasmic Antibody-Associated Vasculitis; 5. Estimated glomerular filtration rate (eGFR) of subjects should be at least 15 mL/min/1.73m2; 6. Provision of written informed consent by patients themselves or their legally acceptable representative.
Exclusion criteria
Exclusion criteria: 1. Subjects receive these previous treatment prior to providing consent to participate in this trial: (1) Receipt of biological B cell depleting agents (e.g. rituximab or belizumab) within 6 months prior to the screening visit; (2) Receipt of Alemtuzumab or anti-thymocyte globulin (ATG) within 12 months prior to the screening visit; (3) Receipt of IVIg, infliximab, etanercept, adamuzumab, abbasizumab, or plasma exchange within 3 months prior to the screening visit; (4) Receipt of another investigational drug within 28 days of screening or within 5 half-lives of the investigational drug (take the longest half-life); 2. Severe or uncontrolled diseases not associated with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis; 3. Any other systemic autoimmune diseases as a co-morbidityincluding Churg-Strauss syndrome (allergic granulomatous vasculitis), systemic lupus erythematosus, anti-GBM disease, or cryoglobulin vasculitis ; 4. HBV infection, HIV infection, active tuberculosis (TB) infection or a history of cancer; 5. Active systemic infection; 6. Allergy to ingredients of Telitacicept; 7. A history of infection such as osteomyelitis, suppurative arthritis or pneumonia with pleural effusion or lung abscess, fungal infection occurred within 6 months prior to the screening visit; 8. Females who are pregnant, breast feeding, or are planning to become pregnant recently; 9. Receipt of a live vaccine within one month; 10. Exclusion criteria related to abnormal laboratory findings: myelosuppression (total white blood cell count 2.5 times the normal upper limit unless attributed to AAV; 11. Subjects participating concurrently in another clinical trial; 12. Subjects considered by the investigator, for other reason, to be an unsuitable candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythrocyte sedimentation rate (ESR);C-reaction protein (CRP);Antineutrophil Cytoplasmic Antibody (ANCA);Immunoglobulin G (IgG);Ferritin;Birmingham Vasculitis Activity Score (BVAS); | — |
Countries
China
Contacts
Public ContactXinwang Duan
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed