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Набор скоро начнётся NCT06833112

Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis

Фаза IV С лечением Ankylosing Spondylitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Secukinumab, Adalimumab.
Кому может быть актуально
Состояния в реестре: Ankylosing Spondylitis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis

Обзор

The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.

Вмешательства

  • Препарат Secukinumab
    The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.
  • Препарат Adalimumab
    The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.

Первичные конечные точки

  • Assessment of SpondyloArthritis International Society 40 (ASAS 40) [Срок оценки: week 52]
  • ASAS40 [Срок оценки: week 104]
  • Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [Срок оценки: week 104]
  • Spondyloarthritis Research Consortium of Canada (SPARCC) [Срок оценки: week 104]
Вторичные конечные точки (12)
  • Assessment of SpondyloArthritis International Society 20 (ASAS20) [Срок оценки: week 12, week 24, week 52]
  • Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6) [Срок оценки: week 12, week 24, week 52]
  • Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR) [Срок оценки: week 12, week 24, week 52]
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 [Срок оценки: week 12, week 24, week 52]
  • BASDAI [Срок оценки: week 12, week 24, week 52]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [Срок оценки: week 12, week 24, week 52]
  • Visual Analogue Scale (VAS) [Срок оценки: week 12, week 24, week 52]
  • Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Срок оценки: week 12, week 24, week 52]
  • tender joint count (TJC), swollen joint count(SJC) [Срок оценки: week 12, week 24, week 52]
  • Ankylosing Spondylitis Disease Activity Score based on C-reactive Protein (ASDAS-CRP) [Срок оценки: week 12, week 24, week 52]
  • Ankylosing Spondylitis Disease Activity Score based on Erythrocyte Sedimentation Rate (ASDAS-ESR) [Срок оценки: week 12, week 24, week 52]
  • Ankylosing Spondylitis Quality of Life (ASQoL) [Срок оценки: week 12, week 24, week 52]

Критерии участия

Критерии включения

  • Male or female at least 18 years old;
  • diagnosed with AS according to the 1984 New York Modified Criteria;
  • Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
  • BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
  • Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
  • Voluntary treatment with adalimumab and secukinumab;
  • Appropriate contraceptive measures for women of childbearing age;
  • without other rheumatic diseases.
  • Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)

Критерии исключения

  • With unstable vital signs, coma, mental and cognitive impairment;
  • Patients with severe systemic diseases and other serious chronic diseases;
  • Pregnant or lactating patients;
  • History of malignant tumor in the past 5 years;
  • Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
  • Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
  • Moderate to severe heart failure (New York Heart Association grade 3-4);
  • Allergic to any of the components of adalimumab (HS016) or secukinumab;
  • Subjects who are participating in clinical research of other drugs;
  • In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Affiliated Hospital of Guizhou Medical University — Guiyang

Идентификаторы

NCT: NCT06833112 · 2024114K

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗