RecruitingPhase 4NCT06410833

Belimumab After Rituximab in Resistant Primary Juvenile SS

Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome


Sponsor

Peking Union Medical College Hospital

Enrollment

15 participants

Start Date

Mar 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two antibody medications (rituximab followed by belimumab) in children and teenagers with Sjögren's syndrome — a condition where the immune system attacks moisture-producing glands, causing dry eyes and dry mouth, and sometimes affecting other organs. This trial is for patients whose condition has not improved with standard treatments. **You may be eligible if...** - You are between 5 and 18 years old - You have a confirmed diagnosis of Sjögren's syndrome - Your condition has not responded well after trying two or more immunosuppressant medications for at least 3 months - You have ongoing complications such as joint pain, blood problems, or organ involvement **You may NOT be eligible if...** - You received rituximab within the past 6 months - You have been treated with certain other biologic medications recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab

Rituximab weekly until B%\<0.5% or B#\<20×10\^6/L

DRUGBelimumab

Belimumab every four weeks


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06410833


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