Using belimumab after rituximab for treating resistant juvenile Sjogren's syndrome
Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
This study is testing if giving belimumab after rituximab can help children aged 5-18 with tough-to-treat juvenile Sjogren's syndrome feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | rituximab, belimumab, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06410833 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of sequential treatment with rituximab followed by belimumab in children aged 5-18 years who have resistant primary juvenile Sjogren's syndrome. Participants will receive rituximab weekly for 2-4 doses until specific blood parameters are met, followed by belimumab starting four weeks after the last rituximab dose, continuing every four weeks for a total of 28 weeks. The study aims to compare disease activity before and after this treatment regimen to determine its efficacy in reducing symptoms of Sjogren's syndrome.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years with a diagnosis of resistant primary juvenile Sjogren's syndrome who have not responded to previous immunosuppressive therapies.
Not a fit: Patients who have been treated with rituximab or other biologics within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve the management of resistant juvenile Sjogren's syndrome in affected children.
How similar studies have performed: While sequential therapies have been explored in other contexts, this specific combination of rituximab and belimumab in juvenile Sjogren's syndrome is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhou
- Email: yzhou11@tsinghua.org.cn
- Phone: +86 01069156251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.