Belimumab After Rituximab in Resistant Primary Juvenile SS

Last updated: May 14, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

Belimumab

Rituximab

Clinical Study ID

NCT06410833
K3926
  • Ages 5-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 5-18 years old.

  2. Meets SS diagnostic AECG criteria or Japan criteria.

  3. classification for "resistant patients": Application of two or moreimmunosuppressants 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) sustainedincreased inflammatory markers, such as ESR

  4. Agree to receive the treatment of rituximab combined with belimumab

Exclusion

Exclusion Criteria:

  1. Previously treated with rituximab within six months, or previously treated withother biologics, including belimumab or Telitacicept

  2. Participate in other clinical trials within 6 months

  3. eGFR<30ml/min

  4. Active infections, including but not limited to: -- Current or past infection withhepatitis B or C as defined by: Hepatitis B surface antigen positive. Hepatitis Bsurface antibody positive and hepatitis B core antibody positive. Hepatitis Cantibody positive. -- Historically positive HIV test or test positive at screeningfor HIV. -- Active tuberculosis.

  5. Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpeszoster and atypical mycobacteria) -- Hospitalisation for treatment of infectionwithin 60 days of Day 0. -- Use of parenteral (intravenous or intramuscular)antibiotics (anti-bacterials, antivirals, anti-fungals or anti-parasitic agents)within 30 days of Day 0. -- Receipt of a live-attenuated vaccine within 3 months ofDay 0. -- In the investigator's opinion, participants that are at high risk forinfection (including but not limited to in dwelling catheter, dysphagia withaspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrentsevere urinary tract infection).

  6. Primary immunodeficiency

  7. History of malignant neoplasm

  8. Severe, progressive or uncontrolled renal, hepatic, haematological,gastrointestinal, pulmonary, cardiac or neurological disease or, in theinvestigator's opinion, any other concomitant medical condition or significantabnormal laboratory value that places the participant at risk by participating inthis trial with the exception of diseases or conditions related to active SS

  9. Comorbidities not SS related currently requiring systemic corticosteroid therapy.

  10. Within 10 days before the first administration of Belimumab, IgG<4g/L or IgA<0.1g/L

  11. WBC<1.5 × 109/L within 10 days before the first administration of Belimumab orneutrophils<1 × 109/L

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Belimumab
Phase: 4
Study Start date:
March 09, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.