Belimumab After Rituximab in Resistant Primary Juvenile SS
NCT ID: NCT06410833
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
15 participants
INTERVENTIONAL
2024-03-09
2026-12-31
Brief Summary
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Does sequential use of rituximab and belimumab reduce the activity of SS in resistant patients
Researchers will compare the disease activity before and after the treatment of sequential use of rituximab and belimumab to see if the therapy works to treat SS.
Participants will:
Recieve Rituximab each week for 2-4 times until B%\<0.5% or B#\<20×10\^6/L Recieve Belimumab 4 weeks after the last use of Rituximab, and then every 4 weeks until week 28
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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sequential use of rituximab and belimumab
Rituximab
Rituximab weekly until B%\<0.5% or B#\<20×10\^6/L
Belimumab
Belimumab every four weeks
Interventions
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Rituximab
Rituximab weekly until B%\<0.5% or B#\<20×10\^6/L
Belimumab
Belimumab every four weeks
Eligibility Criteria
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Inclusion Criteria
2. Meets SS diagnostic AECG criteria or Japan criteria.
3. classification for "resistant patients": Application of two or more immunosuppressants or prednisone +immunosuppressive therapy for more than 3 months. One of the following conditions still exists: a) systemic involvement: polyarthritis, vasculitis, autoimmune cytopenia or involvement of skin, kidney, lung, nerve, and liver. b) constituted B cell activation: elevated IgG, light chain, high β 2MG, C4 decrease, cryoglobulinemia, monoclonal antibody c) sustained increased inflammatory markers, such as ESR
4. Agree to receive the treatment of rituximab combined with belimumab
Exclusion Criteria
2. Participate in other clinical trials within 6 months
3. eGFR\<30ml/min
4. Active infections, including but not limited to: -- Current or past infection with hepatitis B or C as defined by: Hepatitis B surface antigen positive. Hepatitis B surface antibody positive and hepatitis B core antibody positive. Hepatitis C antibody positive. -- Historically positive HIV test or test positive at screening for HIV. -- Active tuberculosis.
5. Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) -- Hospitalisation for treatment of infection within 60 days of Day 0. -- Use of parenteral (intravenous or intramuscular) antibiotics (anti-bacterials, antivirals, anti-fungals or anti-parasitic agents) within 30 days of Day 0. -- Receipt of a live-attenuated vaccine within 3 months of Day 0. -- In the investigator's opinion, participants that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection).
6. Primary immunodeficiency
7. History of malignant neoplasm
8. Severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, pulmonary, cardiac or neurological disease or, in the investigator's opinion, any other concomitant medical condition or significant abnormal laboratory value that places the participant at risk by participating in this trial with the exception of diseases or conditions related to active SS
9. Comorbidities not SS related currently requiring systemic corticosteroid therapy.
10. Within 10 days before the first administration of Belimumab, IgG\<4g/L or IgA\<0.1g/L
11. WBC\<1.5 × 109/L within 10 days before the first administration of Belimumab or neutrophils\<1 × 109/L
5 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Chongqing Medical University
OTHER
Central South University
OTHER
Shenzhen Children's Hospital
OTHER_GOV
The First Hospital of Jilin University
OTHER
Children's Hospital of The Capital Institute of Pediatrics
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Children's Hospital of Nanjing Medical University
OTHER
Children's Hospital of Fudan University
OTHER
Shengjing Hospital
OTHER
Shanghai Children's Hospital
OTHER
Tianjin Children's Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Hongmei Song
Professor
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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K3926
Identifier Type: -
Identifier Source: org_study_id
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