Belimumab After Rituximab in Resistant Primary Juvenile SS

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06410833
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pediatric ALL
  • Sjogren's Syndrome

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab weekly until B%\<0.5% or B#\<20×10\^6/L
  • Belimumab — DRUG
    Belimumab every four weeks

Study Details

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

Key Dates

Start date
Mar 9, 2024
Status verified
May 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: sequential use of rituximab and belimumab

Primary Outcome Measure

Respondence rate [ Time Frame: Week 28 ]

Central Contacts

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