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Belimumab After Rituximab in Resistant Primary Juvenile SS

Study acronym: BRRPJS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 16, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Secondary endpoints: details revised at 1 of 6 entriesv3
  2. Secondary endpoints: details revised at 1 of 6 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06410833
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Children's Hospital of Chongqing Medical University, Central South University, Shenzhen Children's Hospital, The First Hospital of Jilin University, Children's Hospital of The Capital Institute of Pediatrics, The Affiliated Hospital of Qingdao University, Children's Hospital of Nanjing Medical University, Children's Hospital of Fudan University, Shengjing Hospital, Shanghai Children's Hospital, Tianjin Children's Hospital
Conditions Sjogren's Syndrome, Pediatric ALL
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov