Unique ID issued by UMIN | UMIN000022104 |
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Receipt number | R000025482 |
Scientific Title | Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients. |
Date of disclosure of the study information | 2016/04/27 |
Last modified on | 2019/02/28 09:32:43 |
Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Japan |
Ulcerative Colitis
Gastroenterology |
Others
NO
To evaluate the clinical usefulness of fecal calprotectin (FC) as a biomarker to predict the outcome of Adalimumab (ADA) in Ulcerative Colitis (UC) patients.
Efficacy
1. Study design for predicting outcomes:
Evaluation of sensitivity, specificity of FC by comparing the remission rate at week 52 between patients with a decreased FC at 12 week and other patients who have been treated with ADA for 52 weeks.
* Patients with a decreased FC at 12 week: Patients whose values of FC at 12w were <320 microgram/gram and their reduction rates were over 30% comparing to their FC values before ADA induction.
2. Study design for recurrence prediction:
Comparison the value of FC in ADA inducting UC patients (over 12w) between patients who relapsed during following period (minimal following period: 9 month) and patients who did not.
Observational
16 | years-old | <= |
Not applicable |
Male and Female
1. Study design for predicting outcomes: Steroid dependent or moderate to severe UC patients who are decided to include ADA.
2. Study design for recurrence prediction: UC patients who have been treated with ADA as a maintenance therapy for over 12 week.
3. Patients are able to provide written informed consent after having received adequate explanation on the purpose of the study and the nature of the procedures involved.
*In under age cases (below 20 years) consent from one of the patient's parents will be obtained.
4. Patients aged 16 years or older.
1. Pregnant woman
*Patients who become pregnant during study period to be required to discontinue the study
2. Patients unable to provide informed consent.
54
1st name | |
Middle name | |
Last name | Shiro Nakamura MD. PhD. |
Hyogo College of Medicine
Department of Inflammatory Bowel Disease, Division of Internal Medicine
1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
0798-45-6663
shiro@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Takako Miyazaki MD. PhD. |
Hyogo College of Medicine
Department of Inflammatory Bowel Disease, Division of Internal Medicine
1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
0798-45-6663
takako35@hyo-med.ac.jp
Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Self funding
NO
2016 | Year | 04 | Month | 27 | Day |
Unpublished
Terminated
2016 | Year | 01 | Month | 29 | Day |
2016 | Year | 04 | Month | 27 | Day |
2019 | Year | 01 | Month | 07 | Day |
This study has been terminated.
2016 | Year | 04 | Month | 27 | Day |
2019 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025482
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