Unique ID issued by UMIN | UMIN000011200 |
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Receipt number | R000013125 |
Scientific Title | Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization |
Date of disclosure of the study information | 2013/07/17 |
Last modified on | 2019/03/24 15:49:56 |
Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization
Gari-leo study
Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimization
Gari-leo study
Japan |
ulcerative colitis
Medicine in general | Gastroenterology | Adult |
Child |
Others
NO
Relapse rates after the cessation of anti-TNF alpha antibody and clinical response rate after re-administration of anti-TNF alpha antibody
Safety,Efficacy
Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores(PMS) are 3 and over )
Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline)
Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores are 3 points and over ) in patieints with adalimumab and infliximab
Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline) in patieints with adalimumab and infliximab
Biomarkers predicting the relapse after the cessation of anti-TNF alpha antibody
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
the cessation of anti-TNF alpha antibody
15 | years-old | <= |
75 | years-old | > |
Male and Female
Patients in clinical remission state (partial Mayo scores are 3 points and over ) with anti-TNF alpha antibody without steroid for more than 6 months and over.
Patients who cannot continue administration of anti-TNF alpha antibody such as;
Patients with severe infection,
patients with active tuberculosis,
patients with hypersensitivity to anti-TNF alpha antibody,
patients with demyelination diseases, such as multiple sclerosis,
patients with congestive heart failure,
patients with pregnancy,
patients with lactation,
patients without informed consent,
patients who has malignancy and had been cured form malignancy,
patients who experienced colectomy,
and patients who has been determined not to be suitable to this study by doctors
100
1st name | |
Middle name | |
Last name | Shingo Kato |
Saitama Medical Center, Saitama Medical University
Department of Gastroenterology and Hepatology
1981 Kamoda, Kawagoe City
049-228-3564
skato@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Shingo Kato |
Saitama Medical Center, Saitama Medical University
Department of Gastroenterology and Hepatology
1981 Kamoda, Kawagoe City
+81-49-228-3564
skato@saitama-med.ac.jp
Saitama Medical Center, Saitama Medical University
Saitama Medical Center, Saitama Medical University
Self funding
NO
2013 | Year | 07 | Month | 17 | Day |
Partially published
25
Completed
2013 | Year | 08 | Month | 31 | Day |
2013 | Year | 09 | Month | 05 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 11 | Month | 30 | Day |
2013 | Year | 07 | Month | 16 | Day |
2019 | Year | 03 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013125
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