Clinical trial NCT06410833: Belimumab After Rituximab in Resistant Primary Juvenile SS
Official title: Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sjogren's Syndrome
Pediatric ALL
Keywords: Rituximab
Belimumab
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
name: Central South University
name: Shenzhen Children's Hospital
name: The First Hospital of Jilin University
name: Children's Hospital of The Capital Institute of Pediatrics
name: The Affiliated Hospital of Qingdao University
name: Children's Hospital of Nanjing Medical University
name: Children's Hospital of Fudan University
name: Shengjing Hospital
name: Shanghai Children's Hospital
name: Tianjin Children's Hospital
First posted: 2024-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Exclusion Criteria:

1. Previously treated with rituximab within six months, or previously treated with other 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 with hepatitis B or C as defined by: Hepatitis B surface antigen positive. Hepatitis B surface antibody positive and hepatitis B core antibody positive. Hepatitis C antibody positive. -- Historically positive HIV test or test positive at screening for HIV. -- Active tuberculosis.
5. Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) -- Hospitalisation for treatment of infection within 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 of Day 0. -- In the investigator's opinion, participants that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe 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 the investigator's opinion, any other concomitant medical condition or significant abnormal laboratory value that places the participant at risk by participating in this 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 or neutrophils\<1 × 109/L

Primary outcomes:
measure: Respondence rate
timeFrame: Week 28
Secondary outcomes:
measure: Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28
timeFrame: week 0 and 28
measure: Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 28
timeFrame: week 0 and 28
measure: the Sjögren's Tool for Assessing Response (STAR)
timeFrame: week 28
measure: Schirmer test
timeFrame: Week 0 and 28
measure: salivary flow rate
timeFrame: week 0 and 28
measure: Score of salivary ultrasounds
timeFrame: week 0 and 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: