NCT06410833 Belimumab After Rituximab in Resistant Primary Juvenile SS
| NCT ID | NCT06410833 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Sjogren's Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-03-09 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 15 participants in total. It began in 2024-03-09 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to explore the effectiveness of sequential use of rituximab and belimumab in the treatment of resistant primary juvenile Sjogren's syndrome. 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
Eligibility Criteria
Inclusion Criteria: 1. Age 5-18 years old. 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: 1. Previously treated with rituximab within six months, or previously treated with other biologics, including belimumab or Telitacicept 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06410833 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Sjogren's Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06410833 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06410833 currently recruiting?
Yes, NCT06410833 is actively recruiting participants. Contact the research team at yzhou11@tsinghua.org.cn for enrollment information.
Where is the NCT06410833 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06410833 clinical trial?
NCT06410833 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 15 participants.