Actively Recruiting
Belimumab After Rituximab in Resistant Primary Juvenile SS
Led by Peking Union Medical College Hospital · Updated on 2024-05-16
15
Participants Needed
1
Research Sites
146 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
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
Official Title
Belimumab After Rituximab in Resistant Primary Juvenile SS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 to 18 years old
- Meets diagnostic criteria for Sjogren's syndrome by AECG or Japan criteria
- Classified as resistant with use of two or more immunosuppressants or prednisone plus immunosuppressive therapy for over 3 months
- Continuing symptoms such as systemic involvement, B cell activation signs, or increased inflammatory markers
- Agree to receive rituximab followed by belimumab treatment
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) less than 30 ml/min
- Active infections including hepatitis B or C, HIV, tuberculosis, or chronic infections under suppressive therapy
- Hospitalization for infection within 60 days before study start
- Use of intravenous or intramuscular antibiotics within 30 days before study start
- Receipt of live-attenuated vaccine within 3 months before study start
- High risk for infection due to medical conditions or devices
- Primary immunodeficiency
- History of cancer
- Severe or uncontrolled serious diseases other than active Sjogren's syndrome
- Comorbidities requiring systemic corticosteroids
- IgG less than 4 g/L or IgA less than 0.1 g/L within 10 days before first belimumab dose
- White blood cell count less than 1.5 x 10^9/L or neutrophils less than 1 x 10^9/L within 10 days before first belimumab dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Z
Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here