Clinical trial · Interventional
Belimumab After Rituximab in Resistant Primary Juvenile SS
Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
NCT06410833CI-TRIAL-00077208BRRPJSrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Sjogren's Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belimumab | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sequential use of rituximab and belimumab
- interventionNames
- Drug: Rituximab
- Drug: Belimumab
Primary outcomes (1)
- measure
- Respondence rate
- timeFrame
- Week 28
- description
- In the context of the aforementioned criteria, a response is defined as the alteration of more than three of the following five indicators: a) Improvement of physician global assessment score by ≥30% b) Decrease in erythrocyte sedimentation rate (ESR) by ≥30% or normalization c) Improvement of B cell activation markers (IgG, RF) by ≥25% d) Improvement of lacrimal gland function: Improvement of Schirmer test by ≥5mm e) Improvement of salivary gland function: Increase in salivary flow rate by 25% or decrease in ultrasound score by ≥25%.
Secondary outcomes (6)
- measure
- Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.