Belimumab After Rituximab in Resistant Primary Juvenile SS

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Respondence rate [Срок оценки: Week 28]

Вторичные конечные точки (6)

• Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28 [Срок оценки: week 0 and 28]
• Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 28 [Срок оценки: week 0 and 28]
• the Sjögren's Tool for Assessing Response (STAR) [Срок оценки: week 28]
• Schirmer test [Срок оценки: Week 0 and 28]
• salivary flow rate [Срок оценки: week 0 and 28]
• Score of salivary ultrasounds [Срок оценки: week 0 and 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Previously treated with rituximab within six months, or previously treated with other biologics, including belimumab or Telitacicept
• Participate in other clinical trials within 6 months
• eGFR<30ml/min
• 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.
• 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).
• Primary immunodeficiency
• History of malignant neoplasm
• 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
• Comorbidities not SS related currently requiring systemic corticosteroid therapy.
• Within 10 days before the first administration of Belimumab, IgG<4g/L or IgA<0.1g/L
• WBC<1.5 × 109/L within 10 days before the first administration of Belimumab or neutrophils<1 × 109/L

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06410833 · K3926

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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