An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Официальное название

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

Обзор

The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod. All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer. The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.

Вмешательства

• Препарат Etrasimod
  As provided in real world practice

Первичные конечные точки

• Proportion of patients with symptomatic remission [Срок оценки: Week 12]

Вторичные конечные точки (12)

• Proportion of patients with symptomatic remission [Срок оценки: Weeks 24, 36, 52]
• Proportion of patients with symptomatic response [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients with symptomatic response [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients with clinical remission [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients with steroid-free symptomatic remission (among all patients and among patients in symptomatic remission) [Срок оценки: Weeks 24, 36, 52]
• Proportion of patients with steroid-free clinical remission (among all patients and among patients in clinical remission) [Срок оценки: Weeks 24, 36, 52]
• Change from baseline in fatigue [Срок оценки: Weeks 12, 24, 36, 52]
• Change from baseline of bowel urgency [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients with a clinically meaningful improvement in bowel urgency [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients in bowel urgency remission [Срок оценки: Weeks 12, 24, 36, 52]
• Proportion of patients with complete bowel urgency remission [Срок оценки: Weeks 12, 24, 36, 52]
• Change from baseline in abdominal pain [Срок оценки: Weeks 12, 24, 36, 52]

Критерии участия

Критерии включения

• Age ≥ 18 years and < 65 years at baseline
• Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
• Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study

Критерии исключения

• The presence of clinical findings suggestive of Crohn's disease
• Severe extensive colitis evidenced by:

• Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
• Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
• Patients with a stoma or planned UC surgical intervention requiring hospitalization
• Prior/Concomitant Therapy:

• Any previous exposure to etrasimod, including participation in the etrasimod clinical program
• Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
• Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
• Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family

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 · 28 центров

• Reddy GI Associates — Mesa
• Scripps Clinic Torrey Pines — La Jolla
• United Medical Doctors — Los Alamitos
• United Medical Doctors — Los Alamitos
• Rocky Mountain Gastroenterology — Littleton
• Digestive and Liver Center of Florida Kissimmee — Kissimmee
• Gastro Florida — Lutz
• Orlando Health/Digestive Health Institute — Orlando
• … и ещё 20 центров

Идентификаторы

NCT: NCT06398626 · C5041047 · ENDEAVOUR-UC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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