Unique ID issued by UMIN | UMIN000005762 |
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Receipt number | R000006812 |
Scientific Title | The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease |
Date of disclosure of the study information | 2011/06/13 |
Last modified on | 2018/12/19 10:27:06 |
The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
The Efficacy of Adalimumab
The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
The Efficacy of Adalimumab
Japan |
Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
Gastroenterology |
Others
NO
The efficacy and safety of Adalimumab conbined elemental diet therapy for Crohn's disease
Safety,Efficacy
CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
Interventional
Single arm
Non-randomized
Open -no one is blinded
Active
1
Treatment
Medicine |
1)Adalimumab (HUMIRA 40mg for SC Injection)
Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
2)Elental(1 kcal/ml; 80g/300ml)
Not applicable |
Not applicable |
Male and Female
Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
1)The patient who has internal fistula
2)The patient who is planning to have an operation
3)The patient who is short bowel syndorome
4)The patient of contraindication for adalimumab or Elental
5)The case which is hard to get the patient's consent
6)The patient who was judged for unsuitable by responsibility doctor
40
1st name | |
Middle name | |
Last name | Kenji Watanabe |
Osaka City University Gradatescool of Medicine
Gastroenterology
1-4-3, Asahi-machi, Abeno-ku, Osaka
1st name | |
Middle name | |
Last name |
Osaka City University Gradatescool of Medicine
Gastroenterology
nkamata@med.osaka-cu.ac.jp
Kenji Watanabe
none
NO
2011 | Year | 06 | Month | 13 | Day |
Published
Completed
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 27 | Day |
2011 | Year | 06 | Month | 13 | Day |
2018 | Year | 12 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006812
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