Belimumab After Rituximab in Resistant Primary Juvenile SS

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

Conditions

• Sjogren's Syndrome
• Pediatric ALL

Interventions

DRUG

Rituximab

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

DRUG

Belimumab

Belimumab every four weeks

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Shenzhen Children's Hospital

  collaborator OTHER_GOV

• The First Hospital of Jilin University

  collaborator OTHER

• Children's Hospital of The Capital Institute of Pediatrics

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Children's Hospital of Nanjing Medical University

  collaborator OTHER

• Children's Hospital of Fudan University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Shanghai Children's Hospital

  collaborator OTHER

• Tianjin Children's Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

5 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-09

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• China

Study Locations