Идёт набор NCT05003310

ConsideRAte Study - Splenic Stimulation for RA

Без фазы С лечением Rheumatoid Arthritis

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: Active Stimulation, Sham Stimulation, Baricitinib, Background Treatment.
Кому может быть актуально: Состояния в реестре: Rheumatoid Arthritis. Базовые параметры: 22 лет — 75 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: США, Нидерланды
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

Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis

Обзор

This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.

Подробное описание

Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1).

Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks.

At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks.

Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.

Вмешательства

Устройство Active Stimulation
Stimulation will be turned ON and applied during each day of the period.
Устройство Sham Stimulation
Sham stimulation will be provided during the period
Препарат Baricitinib
Baricitinib (2 mg) is administered daily during the period.
Препарат Background Treatment
Stable dose of standard background treatment (e.g., csDMARD therapy)

Первичные конечные точки

Incidence of Adverse Events [Safety and Tolerability] [Срок оценки: Up through the end of Period 1 (Period 1 is up to 12 weeks duration)]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: During Period 2 (Period 2 is up to 12 weeks in duration beyond Period 1)]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: During Period 3 (Period 3 is up to 24 weeks in duration beyond Period 2)]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Срок оценки: During Period 4 (Period 4 is up to 5 years in duration beyond Period 3)]

Вторичные конечные точки (12)

Change in the 28 Joint Disease Activity Score 28 - C reactive protein (DAS28-CRP) [Срок оценки: Baseline to 12 weeks (Period 1)]
Change in the level of Lipopolysaccharide (LPS)-inducible release of Tumor Necrosis Factor (TNFα) in whole blood assay [Срок оценки: Baseline to 12 weeks (Period 1)]
Change in the level of LPS-inducible release of TNFα in whole blood assay [Срок оценки: Baseline to 24 weeks (Period 2)]
Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay [Срок оценки: Baseline to 12 weeks (Period 1)]
Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay [Срок оценки: Baseline to 24 weeks (Period 2)]
Change in the level of LPS-inducible release of IL-8 in whole blood assay [Срок оценки: Baseline to 12 weeks (Period 1)]
Change in the level of LPS-inducible release of IL-8 in whole blood assay [Срок оценки: Baseline to 24 weeks (Period 2)]
Change in the level of LPS-inducible release of IL-17 in whole blood assay [Срок оценки: Baseline to 12 weeks (Period 1)]
Change in the level of LPS-inducible release of IL-17 in whole blood assay [Срок оценки: Baseline to 24 weeks (Period 2)]
Change in DAS28-CRP [Срок оценки: Baseline to 24 weeks (Period 2)]
Change in DAS28-CRP [Срок оценки: Baseline to 36 weeks (Period 3)]
Change in DAS28-CRP [Срок оценки: Baseline to 48 weeks (Period 3)]

Критерии участия

Критерии включения

RA of at least six months duration, per 2010 ACR/EULAR criteria
Male or female participants, 22-75 years of age
Active RA
Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
Have an appropriate washout from previously used biological DMARDs or JAKi
Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance

Критерии исключения

Inability to provide informed consent
Significant psychiatric disease or substance abuse
History of unilateral or bilateral vagotomy
Active or latent tuberculosis
Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
Previous splenectomy

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

Здоровые добровольцы: Нет