Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease
Ключови думи
Резюме
Дати
| Последна проверка: | 01/31/2018 |
| Първо изпратено: | 10/29/2017 |
| Очаквано записване подадено: | 11/20/2017 |
| Първо публикувано: | 11/23/2017 |
| Изпратена последна актуализация: | 02/21/2018 |
| Последна актуализация публикувана: | 02/22/2018 |
| Действителна начална дата на проучването: | 02/13/2018 |
| Приблизителна дата на първично завършване: | 07/31/2018 |
| Очаквана дата на завършване на проучването: | 07/31/2018 |
Състояние или заболяване
Интервенция / лечение
Biological: Group Ustekinumab
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Group Ustekinumab Patients presenting an active crohn's disease (HBI score ≥ 4) with an indication of treatment by ustekinumab because of failure or unacceptable side effects of previous treatments, and who have already been treated by at least one anti TNF The patients must be 18 years old or older. | Biological: Group Ustekinumab The clinical response is defined as a decrease in the Crohn's Disease Activity Index (CDAI) score ≥ 100 points or a decrease in the HBI score ≥ 3 points. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Метод за вземане на проби | Non-Probability Sample |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Age > 18 years old - Man or non pregnant woman - Diagnostic attested of Crohn's disease - Active Crohn's disease, with HBI score ≥ 4 - Previous treatment by at least one anti TNF and / or vedolizumab,, with primary non response, secondary loss of response or unacceptable side effects - Formal indication of treatment by ustekinumab - Patient informed and not opposed to his participation at the study Exclusion Criteria: - Pregnancy - Evolutive cancer - Evolutive and uncontrolled infection - Psychiatric pathology that could interfere with the follow-up - Refusal of the patient |
Резултат
Първични изходни мерки
1. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 8. [Week 8]
Вторични изходни мерки
1. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 4. [Week 4]
2. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 16. [Week 16]
3. Measurement of serum ustekinumab trough concentrations (expressed in microg/mL) at week 24. [Week 24]
4. Dosage in blood at week 4 [Week 4]
5. Dosage in blood at week 8 [Week 8]
6. Dosage in blood at week 16 [Week 16]
7. Dosage in blood at week 24 [Week 24]
8. Dosage of calprotectin in stools at week 4 [Week 4]
9. Dosage of calprotectin in stools at week 8 [Week 8]
10. Dosage of calprotectin in stools at week 16 [Week 16]
11. Dosage of calprotectin in stools at week 24 [Week 24]
12. Physical evaluation at week 4 [Week 4]
13. Physical evaluation at week 8 [Week 8]
14. Physical evaluation at week 16 [Week 16]
15. Physical evaluation at week 24 [Week 24]
16. Clinical evaluation at week 4 [Week 4]
17. Clinical evaluation at week 8 [Week 8]
18. Clinical evaluation at week 16 [Week 16]
19. Clinical evaluation at week 24 [Week 24]
