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Набор по приглашению NCT07564609

the REMONO-CD and the REMONO-UC Studies

— Наблюдательное Crohn Disease (CD) Ulcerative Colitis (UC)

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: Crohn Disease (CD), Ulcerative Colitis (UC). 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
Франция
Следующий шаг
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Официальное название

Non-inferiority REal-world Evidence Study Comparing the Effectiveness of Subcutaneous Infliximab MONOtherapy and Subcutaneous Infliximab Combined With Immunosuppressive Therapy in Patients With Crohn's Disease and Ulcerative Colitis.

Обзор

Infliximab was the first-in-class anti-TNF agent approved for treating patients with IBD, both for Crohn's disease (CD)1 and ulcerative colitis (UC)2. Infliximab is administered by intravenous infusions and demonstrated its superiority over placebo to induce and maintain steroid-free clinical remission. Besides, SONIC and SUCCESS trials showed that combination therapy (infliximab + immunosuppressant) was more effective than infliximab alone to induce clinical remission3,4. Moreover, the PANTS cohort confirmed the benefits of combination therapy to induce remission and to prevent immunogenicity over time5. Accordingly, current guidelines recommend to use infliximab in combination with an immunosuppressive therapy. Recently, subcutaneous (SC) infliximab has been developed and is now approved for patients with CD and UC6. The LIBERTY-CD and LIBERTY-UC trials showed that SC infliximab is more effective than placebo to maintain clinical remission7. Real-world evidence studies, such as the REMSWITCH program8,9, reported that switching from IV to SC infliximab is feasible, safe and well accepted leading to a low risk of relapse including in patients with intensified IV doses. In addition to its better acceptability compared to IV regimen, SC infliximab seems to have a better pharmacokinetic profile that can lead to reduced risk of immunogenicity and thus question the need for using combination therapy with SC infliximab6-9. No data enables to draw any firm conclusion on this topic10. In the REMONO studies (REMONO-UC and REMONO-CD), we aim to show the non-inferiority of SC infliximab monotherapy to maintain steroid-free clinical remission compared to combination therapy in patients with CD and UC.

Подробное описание

It will be a retrospective multicentre study (22 centres). Data will be collected from the electronic medical records and pseudonymized from routine clinical care between 01/01/2023 and 01/07/2025. Data will be entered the electronic CRF (RedCAP).

The main data collected at the different time points : age, disease duration, smoking status, prior bowel resection, Montreal classification (location, behaviour, extent), perianal lesions, upper GI involvement, previous IBD medications, concomitant IBD medications (including doses and intervals), disease activity (stool frequency, abdominal pain, bowel urgency, CRP level, faecal calprotectin level, endoscopic activity, MRI scores, IUS lesions), side effects, pharmacokinetics (infliximab serum level, anti-infliximab antibodies).

Первичные конечные точки

  • Steroid-free clinical remission in REMONO CD [Срок оценки: From 3 months up to 1 year after the start of treatment]
  • Steroid-free clinical remission in REMONO UC [Срок оценки: From 3 months up to 1 year after the start of treatment]

Критерии участия

Критерии включения

  • Patients with UC (REMONO-UC) or with CD (REMONO-CD) ≥ 18 years
  • Who received at least one SC injection of infliximab after IV induction (5 mg/kg at week 0, week 2 ± week 6)
  • Infliximab started for symptomatic CD (PRO2: abdominal pain > 1 or stool frequency >3) or UC (partial Mayo score >2)
  • Follow-up of at least 3 months (except for those who failed or were intolerant to SC infliximab before 3 months)

Критерии исключения

  • Unclassified colitis
  • Infliximab started for isolated perianal CD, to prevent CD endoscopic postoperative recurrence or for acute severe colitis
  • Permanent stoma
  • Total colectomy with IPAA
  • Concomitant other biological therapy or small molecule

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 18 центров
  • CHU Amiens — Amiens
  • CHU Besançon — Besançon
  • CHU Clermont Ferrand — Clermont-Ferrand
  • Hôpital Beaujon AP-HP — Clichy
  • Hôpital Henri-Mondor AP-HP — Créteil
  • CHU Dijon — Dijon
  • CHU Grenoble — Grenoble
  • Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre
  • … и ещё 10 центров

Идентификаторы

NCT: NCT07564609 · 2025 BUISSON_CF525

Первоисточники (государственные реестры)

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