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Идёт набор NCT06968975

Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

— Наблюдательное Polyneuropathy, Inflammatory Demyelinating, Chronic

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Polyneuropathy, Inflammatory Demyelinating, Chronic. 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
США
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

Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Обзор

This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.

Первичные конечные точки

  • I-RODS score at baseline [Срок оценки: Baseline]
  • Variations of I-RODS score over the study duration [Срок оценки: From Baseline up to End of Study (2 years)]
  • Variations of I-RODS score after treatment change [Срок оценки: From baseline up to End of Study (approx. 2 years)]
  • Annualized I-RODS response rate [Срок оценки: Up to End of Study (approx. 2 years)]
  • Annualized I-RODS relapse rate [Срок оценки: Up to End of Study (approx. 2 years)]
Вторичные конечные точки (8)
  • Adjusted INCAT (aINCAT) score at baseline and its variations over the study duration and after treatment change [Срок оценки: Baseline and throughout the study (up to 2 years)]
  • Annualized aINCAT response rate [Срок оценки: Up to End of Study (approx. 2 years)]
  • Annualized aINCAT relapse rate [Срок оценки: Up to End of Study (approx. 2 years)]
  • Interobserver variability of remote INCAT assessment [Срок оценки: Up to End of Study (approx. 2 years)]
  • Incidence of select comorbidities at baseline and over the study duration [Срок оценки: From Baseline up to End of Study (approx. 2 years)]
  • Frequency of select comorbidities at baseline and over the study duration [Срок оценки: From Baseline up to End of Study (approx. 2 years)]
  • Laboratory measurements at baseline and over study duration [Срок оценки: From Baseline up to End of Study (approx. 2 years)]
  • CAP-PRI score at baseline and its variations over the study duration and after treatment change [Срок оценки: From Baseline to End of Study (approx 2 years)]

Критерии участия

Критерии включения

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed
  • Active use of at least one of the following CIDP treatments for three months or longer, with no evidence of discontinuation of this therapy as of the last neurologist visit prior to enrollment
  • immunoglobulin
  • corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day
  • plasma exchange
  • efgartigimod alfa
  • azathioprine
  • mycophenolate mofetil
  • cyclosporine
  • rituximab
  • methotrexate
  • Signed informed consent
  • Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

  • Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
  • Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
  • Aged under 18 at the time of enrollment

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Investigational Site — Swiftwater

Идентификаторы

NCT: NCT06968975 · OBS18653

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗