Study of Rituximab Followed by Belimumab for Treating Resistant Primary Juvenile Sjogrens Syndrome in Children and Teens

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 Sjogrens 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.

Belimumab After Rituximab in Resistant Primary Juvenile SS