Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

Официальное название

Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab

Обзор

This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in pediatric patients) and infliximab (used as standard therapy), in pediatric patients with UC aged 6-18 years. Before enrollment to the study, informed consent must be obtained from the participant's legal guardian and, additionally, from the participant aged \>16 years before any procedures are performed.

Вмешательства

• Препарат Infliximab
  Patients meeting the inclusion criteria and not having any of the exclusion criteria will be randomized 1:1 to one of two study arms - intravenous administration of blinded active drug, infliximab or vedolizumab at weeks 0, 2, 6 and 14. Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg (body mass \> 40 kg) and 10 mg/kg (body mass \< 40kg).

Первичные конечные точки

• Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs). [Срок оценки: screening - Week 20]

Критерии участия

Критерии включения

• Participant aged 6 to 17 years at the time of study entry.
• Patient with moderate or severe UC defined by the PUCAI score (min. 30 points) - diagnosed at least 1 month before the qualifying visit.
• Individuals who failed to respond to, lost response to, or were intolerant to treatment with at least 1 of the following agents:

• corticosteroids (prednisone at a dose of 1 mg/kg/day with a maximum dose of 40 mg/day, budesonide MMX 9 mg/day) or immunomodulating drugs (e.g. AZA, 6-MP, MTX).
• in the case of 5 - ASA adrugs, corticosteroids, immunomodulating drugs, doses should remain stable for 2 weeks before administration of the study drug
• Patients with UC proximal to the rectum (i.e. not limited to proctitis).
• At least Mayo 1 on the endoscopic scale
• People with up-to-date vaccinations in accordance with the preventive vaccination program adopted in Poland.

Критерии исключения

• People who have been previously treated with biological antiintegrin preparations, including: natalizumab, efalizumab, etrolizumab or addressin-1 adhesion molecule antagonists or rituximab.
• People who were previously treated with vedolizumab.
• People who were previously treated with infliximab
• People with hypersensitivity or allergy to any of the excipients of vedolizumab or infliximab
• People with active brain/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other serious neurological disorder including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
• Individuals who currently require or are expected to require surgical intervention for UC during this study.
• People who have had a partial or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal stoma, or known permanent intestinal stricture.
• People with a current diagnosis of unspecified colitis.
• People with clinical features suggestive of monogenic inflammatory bowel disease of very early onset.
• The participant has other serious comorbidities that will limit his or her ability to complete the study.
• Abnormal laboratory tests:

• Hgb ≤ 8 g/dl
• Leukocytes ≤ 2.5 x 10\*9 cells/L
• ALT and/or AST ≥ 3 x upper limit of normal
• positive Quantiferon result
• positive result in the stool sample for Clostridium difficile and/or stool culture for alarm pathogens Security

At every check-up visit:

• occurrence of: adverse events (AEs), serious AEs (serious AEs-SAEs), infections including opportunistic infections such as PML, liver damage, malignant tumors, infusion-related reactions and hypersensitivity
• vital signs, results of standard laboratory tests

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06614387 · CT 2023-509775-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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