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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• Age 5-18 years old.

• Meets SS diagnostic AECG criteria or Japan criteria.

• classification for resistant patients: Application of two or more immunosuppressants or prednisone +immunosuppressive therapy for more than 3 months. One of the following conditions still exists: a) systemic involvement: polyarthritis, vasculitis, autoimmune cytopenia or involvement of skin, kidney, lung, nerve, and liver. b) constituted B cell activation: elevated IgG, light chain, high β 2MG, C4 decrease, cryoglobulinemia, monoclonal antibody c) sustained increased inflammatory markers, such as ESR

• Agree to receive the treatment of rituximab combined with belimumab

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhou
yzhou11@tsinghua.org.cn
+86 01069156251
Time Frame
Start Date: 2024-03-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Experimental: sequential use of rituximab and belimumab
Sponsors
Collaborators: Central South University, Children's Hospital of Nanjing Medical University, Tianjin Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, The First Hospital of Jilin University, Children's Hospital of Fudan University, The Affiliated Hospital of Qingdao University, Shanghai Children's Hospital, Shenzhen Children's Hospital, Children's Hospital of Chongqing Medical University, Shengjing Hospital
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov