Unique ID issued by UMIN | UMIN000007047 |
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Receipt number | R000008194 |
Scientific Title | Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease |
Date of disclosure of the study information | 2012/01/10 |
Last modified on | 2020/07/18 12:17:59 |
Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Effect of adacolumn and adalimumab combination therapy for Crohn's disease
Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Effect of adacolumn and adalimumab combination therapy for Crohn's disease
Japan |
Crohn's disease
Gastroenterology |
Others
NO
Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease
Efficacy
Exploratory
Pragmatic
Not applicable
Remission induction rate 11 weeks after the start of therapy.
Remission rate 104 weeks after the start of therapy.
Remission period
CT or CT enteroclysis/enterography
Change of the CRP
Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Adacolumn and adalimumab combination therapy for 10 weeks.
Adalimumab single therapy for remain 94 weeks.
Adacolumn single therapy for 104 weeks.
12 | years-old | <= |
75 | years-old | > |
Male and Female
The patient that it was judged that keeping blood access was possible.
The patient that agreed this study.
Below 2,000 / mm3 granulocyte count
Severe infection
Severe heart disease
Severe Renal disease
Systolic blood pressure less than 80mmHg
patient with suspected or currently pregnant
Increased intensity of extreme dehydration or coagulation system
Severe anemia
Malignant tumor
Short-bowel syndrome
Artificial anus
External fistula
Ileus or svere stenosis of the intestine
Extraintestinal complications
Recent use of steroid, 5-Aminosalicylic acid, immunomodulator, biologics, elemental diet
Recent operation
40
1st name | |
Middle name | |
Last name | Shinichi Hashimoto |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterology and Hepatology
1-1-1 Minami-Kogushi, Ube, Yamaguchi
0836-22-2241
1st name | |
Middle name | |
Last name | Shinichi Hashimoto |
Yamaguchi University Graduate School of Medicine
Department of Gastroenterology and Hepatology
1-1-1 Minami-Kogushi, Ube, Yamaguchi
0836-22-2241
has-333@yamaguchi-u.ac.jp
Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology
none
Self funding
NO
山口大学医学部付属病院 Yamaguchi University Hospital
セントヒル病院 Sainthill hospital
2012 | Year | 01 | Month | 10 | Day |
Unpublished
Terminated
2010 | Year | 10 | Month | 20 | Day |
2011 | Year | 10 | Month | 26 | Day |
2011 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 01 | Day |
2015 | Year | 12 | Month | 10 | Day |
2015 | Year | 12 | Month | 10 | Day |
2015 | Year | 12 | Month | 10 | Day |
2012 | Year | 01 | Month | 10 | Day |
2020 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008194
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