A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
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: Vedolizumab IV, No Intervention.
- Кому может быть актуально
- Состояния в реестре: Ulcerative Colitis, Crohn's Disease. Базовые параметры: от 2 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, Австралия, Бельгия, Канада, Китай +13
- 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 Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Обзор
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Подробное описание
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 \[participants with UC\] and MLN0002-3025 \[participants with CD\], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort.
Treatment Cohort:
The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD.
Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups:
* Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose) * Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose) * Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) * Participants \>15 to \<30 kg, Vedolizumab 100 mg (Low dose) * Participants ≥30 kg, Vedolizumab 300 mg (High dose) * Participants ≥30 kg, Vedolizumab 150 mg (Low dose)
Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study.
The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug.
Observational Cohort:
Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV.
The overall time to participate in the Observational Cohort is up to approximately 2 years.
Вмешательства
- Препарат Vedolizumab IV
Vedolizumab IV infusion - Другое No Intervention
Participants will not receive any intervention in the Observational Cohort.
Первичные конечные точки
- Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) [Срок оценки: From first dose of study drug up to approximately 5 years]
- Observational Cohort: Number of Participants With Prespecified Safety Events [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (8)
- Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events [Срок оценки: Up to approximately 5 years]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
- Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks [Срок оценки: Baseline, every 24 weeks in this study (up to approximately 5 years)]
Критерии участия
Main Inclusion Criteria:
For Treatment Cohort:
- The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.
- A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
For Observational Cohort:
1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
Main Exclusion Criteria:
For Treatment Cohort only:
- The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
- The participant has other serious comorbidities that will limit their ability to complete the study.
- The participant is unable to comply with all study assessments.
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
- The participant is lactating or pregnant.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 22 центра
- University of South Alabama (USA) Physicians Group — Mobile
- Phoenix Childrens Hospital - Thomas Rd - PIN — Phoenix
- Cedars Sinai Medical Center - 127 San Vicente Blvd — Los Angeles
- Rady Children's Hospital - San Diego - PIN — San Diego
- University of California San Francisco — San Francisco
- I.H.S Health LLC-Kissimmee-445 W Oak St — Kissimmee
- Childrens Center For Digestive Healthcare — Atlanta
- Advocate Children's Hospital - Park Ridge - PIN — Park Ridge
- … и ещё 14 центров
Польша · 10 центров
- Uniwersytecki Szpital Dzieciecy w Krakowie — Krakow
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Past — Wroclaw
- WIP Warsaw IBD Point Profesor Kierkus — Warsaw
- Instytut Pomnik Centrum Zdrowia Dziecka — Warsaw
- Korczowski Bartosz, Gabinet Lekarski — Rzeszów
- Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50 — Gdansk
- Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach — Katowice
- Twoja Przychodnia SCM - Slowackiego — Szczecin
- … и ещё 2 центра
Израиль · 7 центров
- Tel Aviv Sourasky Medical Center Ichilov - PPDS — Jerusalem
- Shaare Zedek Medical Center — Jerusalem
- Soroka University Medical Centre — Beersheba
- Rambam Health Care Campus PPDS — Haifa
- Carmel Medical Center — Haifa
- Hadassah Medical Center- Ein Kerem - PPDS — Jerusalem
- Schneider Childrens Medical Center of Israel Petah Tikvah PIN — Petah Tikva
Италия · 7 центров
- Azienda Ospedaliera Universitaria Federico II — Naples
- Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2 — Naples
- Azienda USL di Bologna — Bologna
- Sapienza University of Rome — Rome
- Fondazione IRCCS San Gerardo dei Tintori — Monza
- Azienda Ospedaliero Universitaria A Meyer — Florence
- Universita degli Studi di Padova — Padova
Великобритания · 6 центров
Список центров уточняется — проверьте первичный протокол.
Китай · 5 центров
- Beijing Children's Hospital, Capital Medical University - PIN — Пекин
- Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus — Чжэнчжоу
- Hunan Children's Hospital — Чанша
- Children's Hospital of Fudan University — Шанхай
- The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus — Ханчжоу
Япония · 5 центров
- Kurume University Hospital — Kurume-Shi
- Japanese Red Cross Kumamoto Hospital — Kumamoto
- Saitama Children's Medical Center-1397-1 yamane — Hidaka
- Juntendo University Hospital — Bunkyo-Ku
- National Center for Child Health and Development — Setagaya-Ku
Испания · 5 центров
Список центров уточняется — проверьте первичный протокол.
Австралия · 4 центра
- Children's Hospital at Westmead — Westmead
- Queensland Childrens Hospital — South Brisbane
- Monash Health, Monash Medical Centre — Clayton
- Royal Children's Hospital Melbourne - PIN — Parkville
Канада · 4 центра
- University of Alberta Hospital — Edmonton
- British Columbia Children's Hospital - 4480 Oak St — Vancouver
- London Health Sciences Centre -800 Commissioners Rd E — London
- Centre Hospitalier Universitaire Sainte-Justine — Montreal
Греция · 4 центра
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Athens
- Children's Hospital Agia Sofia — Athens
- General Hospital of Thessaloniki ''Hippokratio'' — Thessaloniki
- General Hospital of Thessaloniki ''Hippokratio'' — Thessaloniki
Венгрия · 4 центра
- Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz — Miskolc
- Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika — Szeged
- Clinexpert Obuda Egeszsegcentruma — Budapest
- Semmelweis Egyetem, Pulmonologiai Klinika — Budapest
South Korea · 4 центра
Список центров уточняется — проверьте первичный протокол.
Бельгия · 3 центра
- UZ Antwerpen - PIN — Edegem
- UZ Brussel - PIN — Jette
- UZ Leuven — Leuven
Хорватия · 3 центра
- Children's Hospital Zagreb — Zagreb
- University Hospital Center Zagreb — Zagreb
- University Hospital of Split-Spinciceva 1 — Split
Чехия · 2 центра
- Fakultni nemocnice Kralovske Vinohrady — Prague
- Fakultni Thomayerova Nemocnice — Prague
Литва · 2 центра
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas
- Vilnius University Hospital Santaros Klinikos — Vilnius
Словакия · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT05442567 · MLN0002-3029 · 2023-509046-36-00 · jRCT2071230036