Actively Recruiting
Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
Led by Peking Union Medical College Hospital · Updated on 2024-05-16
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
C
Children's Hospital of Chongqing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of using rituximab followed by belimumab to treat children and adolescents aged 5 to 18 with resistant primary juvenile Sjogren's syndrome. The study aims to see if this sequential treatment can reduce disease activity in patients who have not responded well to previous therapies. This Phase 4 trial is sponsored by Peking Union Medical College Hospital and focuses on evaluating symptom changes and disease markers over 28 weeks. Participants will receive rituximab weekly for 2 to 4 doses until specific blood B cell levels are low enough. Then, four weeks after the last rituximab dose, they will start belimumab infusions every four weeks until week 28. The study treatment follows this schedule to assess how the combination may affect the disease over time. During the trial, participants will undergo assessments including disease activity scores, patient-reported symptoms, tear production tests, saliva flow measurements, and ultrasound imaging of salivary glands at the start and at week 28. Researchers will monitor response rates and changes in these outcomes to understand treatment effects. The total participation period covers the 28-week treatment and evaluation phase, with safety monitored throughout.
CONDITIONS
Brief Title
Belimumab After Rituximab in Resistant Primary Juvenile SS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 5 and 18 years old
- Diagnosed with primary juvenile Sjogren's syndrome meeting AECG or Japan criteria
- Resistant disease defined as prior use of two or more immunosuppressants or prednisone plus immunosuppressive therapy for over 3 months
- Presence of ongoing systemic involvement, B cell activation markers, or increased inflammatory markers
- Agree to receive treatment with rituximab combined with belimumab
You will not qualify if you...
- Previous treatment with rituximab within 6 months or other biologics including belimumab or Telitacicept
- Participation in other clinical trials within 6 months
- Estimated glomerular filtration rate (eGFR) below 30 ml/min
- Active infections such as hepatitis B or C, HIV, or tuberculosis
- Current suppressive therapy for chronic infections or recent hospitalization for infection
- Use of parenteral antibiotics within 30 days of Day 0
- Receipt of live-attenuated vaccine within 3 months of Day 0
- High risk for infection due to medical conditions or devices
- Primary immunodeficiency
- History of malignant tumors
- Severe or uncontrolled major organ diseases or other conditions posing risk
- Comorbidities requiring systemic corticosteroid therapy unrelated to Sjogren's syndrome
- Low immunoglobulin levels or low white blood cell or neutrophil counts before belimumab administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable, until B% <0.5% or B# <20×10^6/L
Participants receive Rituximab weekly until specific blood B cell levels are reached.
Weekly visits during Rituximab treatment
Duration - Up to 28 weeks
Participants receive Belimumab every four weeks following Rituximab treatment.
Visits every four weeks for Belimumab administration
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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