Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels (GO-LEVEL)
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
Patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. Patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.
Обзор исследования
Подробное описание
The study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy:
Cohort 1: Patients commencing golimumab induction therapy will be included in a prospective, observational study.
Cohort 2: Patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study.
Primary objective: To define a week 6 serum golimumab concentration that predicts response at week 14.
Secondary objective: To define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14.
Exploratory objectives:
Correlations between serum golimumab concentrations and novel disease activity indices (PRO2), biochemical markers of disease activity (CRP, faecal calprotectin) and quality of life indices (IBD-Q and IBD-Control).
Correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and UC disease activity.
This study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (PRO) assessment of clinical UC disease activity.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
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-
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London, Соединенное Королевство
- Guy's & St Thomas' NHS Foundation Trust
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria for cohort 1:
- Aged 18 years or over
- Moderate-to-severe UC, defined as:
SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study enrollment
- Commencing golimumab treatment
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Inclusion Criteria for cohort 2:
- Aged 18 years or over
- Receiving golimumab treatment for UC for over 18 weeks (6 injections)
- Written informed consent to participate
- Sufficient English language skills to understand the patient information sheet and consent form
Exclusion Criteria (cohort 1 only):
- Contra-indication to golimumab: tuberculosis or severe infections
- Imminent need for colectomy (i.e. colectomy is being planned)
- Previous primary non-response to anti-TNF therapy in the opinion of the investigator
- Previous treatment with more than one anti-TNF therapy (excluding golimumab)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: Induction cohort
Golimumab induction therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Другие имена:
|
|
Другой: Maintenance cohort
Golimumab maintenance therapy
|
A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Serum Golimumab Concentration (μg/ml)
Временное ограничение: Week 6 during induction therapy and at the point of study entry during maintenance
|
Evaluated using an enzyme-linked immunosorbent assay (ELISA)
|
Week 6 during induction therapy and at the point of study entry during maintenance
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Patients in Clinical Remission
Временное ограничение: Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
Evaluated using the Simple Clinical Colitis Activity Index (SCCAI).
Remission defined as SCCAI < 3.
|
Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Faecal Calprotectin (μg/g)
Временное ограничение: Week 14 during induction therapy and at the point of study entry during maintenance
|
Faecal inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum C-Reactive Protein (mg/L)
Временное ограничение: Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum inflammatory marker with higher values suggestive of increasing biochemical disease activity
|
Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Serum Albumin (g/L)
Временное ограничение: Week 14 during induction therapy and at the point of study entry during maintenance
|
Serum protein marker with higher values associated with increasing inflammatory activity and lower serum levels of anti-TNF agents (such as golimumab)
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Week 14 during induction therapy and at the point of study entry during maintenance
|
|
Clinical UC Disease Activity
Временное ограничение: Week 14 during maintenance therapy and at the point of study entry during maintenance
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Evaluated using Patient Reported Outcome 2 (PRO2).
PRO2 ranges from 0-5 with higher scores denoting increasing clinical disease activity.
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Week 14 during maintenance therapy and at the point of study entry during maintenance
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Quality of Life (IBD-Control)
Временное ограничение: Week 14 during induction therapy and at the point of study entry during maintenance therapy
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Evaluated using IBD-Control questionnaires.
IBD-Control scores range from 0-16 with higher scores denoting better quality of life.
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Week 14 during induction therapy and at the point of study entry during maintenance therapy
|
|
Number of Patients With Detectable Anti-golimumab Antibodies
Временное ограничение: At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
Evaluated using a drug-sensitive enzyme-linked immunosorbent assay (ELISA)
|
At any study time point during induction therapy (weeks 6, 10 or 14) and at the point if study entry during maintenance
|
Соавторы и исследователи
Соавторы
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Гастроэнтерит
- Заболевания толстой кишки
- Кишечные заболевания
- Воспалительные заболевания кишечника
- Колит
- Колит, язвенный
- Физиологические эффекты лекарств
- Противовоспалительные агенты
- Иммунодепрессанты
- Иммунологические факторы
- Ингибиторы фактора некроза опухоли
- Голимумаб
Другие идентификационные номера исследования
- 2017-001374-42
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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продукт, произведенный в США и экспортированный из США.
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