Идёт набор NCT04955899

Safety of 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.
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: Нидерланды, Великобритания
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

A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device

Обзор

This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. 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). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.

Подробное описание

The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Вмешательства

Устройство Active Stimulation
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Первичные конечные точки

Safety and tolerability of the Galvani system [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

Effect of stimulation on the change in pharmacodynamic and response biomarkers [Срок оценки: Day 1 to week 12]
To evaluate the usability of the external Galvani System devices and accessories [Срок оценки: 12 weeks]
To evaluate the participants' perception of therapy and sensation [Срок оценки: 12 weeks]
Evaluate device performance [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

Adult-onset RA of at least six months duration
Male or female participants, 22-75 years of age
Active RA
Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
Have an appropriate washout from previously used biological DMARDs or JAKi
A female participant should have no child-bearing potential

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.
Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
Previous splenectomy
Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
Uncontrolled other inflammatory diseases
Current/recurrent infections that in the opinion of the PI risk>benefit.
History of cancer within the past 5 years, except non-malignant skin cancer.
Chronic use of morphine or oxicodone

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

Здоровые добровольцы: Нет