Unique ID issued by UMIN | UMIN000034662 |
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Receipt number | R000039407 |
Scientific Title | Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study |
Date of disclosure of the study information | 2018/10/29 |
Last modified on | 2022/11/08 18:06:52 |
Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study
Efficacy of tight control management on Japanese CD patients treated with biologics
Efficacy of tight control management on Japanese Crohn's disease patients treated with biologics: a multicenter prospective cohort study
Efficacy of tight control management on Japanese CD patients treated with biologics
Japan |
Crohn's disease
Gastroenterology |
Others
NO
To clarify whether tight control management based on clinical symptoms combined with biomarkers results in better outcome
To identify optimal biomarkers and their optimal standards for tight control management from clinical symptoms, serum or fecal biomarkers
Safety,Efficacy
Clinical remission and mucosal healing rates 52 weeks after the treatment with biologics
Rate of major adverse outcomes (hospitalization, surgery, discontinuation due to treatment failure)
Factors associated with clinical remission, mucosal healing or major adverse outcomes
Observational
16 | years-old | <= |
Not applicable |
Male and Female
Ileal, colonic, or ileocolonic Crohn's disease patients treated with biologics (anti-TNF agents, ustekinumab or vedolizumab)
1) Patients with severe infection (sepsis, etc.)
2) Patients with active tuberculosis
3) Patients with history of hypersensitivity to the ingredient of anti-TNF antibody, ustekinumab, or vedolizumab, or the protein of mouse origin
4) Patients with demyelinating disease (multiple sclerosis, etc.) or with history of demyelinating disease
5) Patients with congestive heart failure
6) Patients treated with two or more biologics in combination
7) Patients under 16 years old
8) Patients judged as inappropriate by physicians
100
1st name | Hisashi |
Middle name | |
Last name | Shiga |
Tohoku University Hospital
Division of Gastroenterology
980-8574
1-1 Seiryo, Aoba, Sendai, Japan
022-717-7171
shiga@med.tohoku.ac.jp
1st name | Hisashi |
Middle name | |
Last name | Shiga |
Tohoku University Hospital
Division of Gastroenterology
980-8574
1-1 Seiryo, Aoba, Sendai, Japan
022-717-7171
shiga@med.tohoku.ac.jp
Tohoku University Hospital
Division of Gastroenterology
None
Self funding
Tohoku University School of Medicine, Ethics Committee
2-1 Seiryo, Aoba, Sendai, Japan
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
NO
2018 | Year | 10 | Month | 29 | Day |
Unpublished
Main results already published
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 10 | Month | 29 | Day |
2022 | Year | 09 | Month | 30 | Day |
none
2018 | Year | 10 | Month | 26 | Day |
2022 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039407
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