Unique ID issued by UMIN | UMIN000007343 |
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Receipt number | R000008656 |
Scientific Title | The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients |
Date of disclosure of the study information | 2012/02/21 |
Last modified on | 2019/09/04 17:49:49 |
The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients
Japan |
Crohn's disease
Gastroenterology |
Others
NO
To evaluate the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients.
Safety,Efficacy
Not applicable
The occurrence of relapse
(Relapse was defined as either the increase of CDAI score of more than 70 points compared with the score at week 8, or the need for therapy to induce remission.)
1) The rate of clinical response (CDAI score of less than 220) at week 8
2) The rate of mucosal healing at week 24 and 48
3) Safety assessment
etc.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody).
Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy.
20 | years-old | <= |
Not applicable |
Male and Female
Eligible patients have active Crohn's disease with a CDAI score of 220 to 450 points, and have a clinical response to anti-TNF antibody with a CDAI score of less than 220 at week 8.
This study is especially aimed at the patients who require dose escalation of 1st anti-TNF antibody or switch to 2nd anti-TNF antibody, after loss of response and/or intolerance to 1st anti-TNF antibody.
(1) anti-TNF antibody contraindication
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, 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
(2) Pregnant or likely to be pregnant women
(3) Pregnant or lactating women
(4) Patients < 20 years of age
(5) Patients not approving the study consent
(6) Patients who have severe obstructive strictures or abdominal abscess assessed by X-ray, abdominal computed tomography, or endoscopy
(7) Patients with active hepatitis B or C
(8) Patients with human immunodeficiency virus
(9) Patients with malignancy
(10) Patients judged as inadequate at the discretion of physicians
90
1st name | |
Middle name | |
Last name | Katsuya Endo |
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division of Gastroenterology
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
022-717-7171
kendo@med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Hisashi Shiga |
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
Division of Gastroenterology
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
022-717-7171
shiga@med.tohoku.ac.jp
Tohoku University Graduate School of Medicine (Tohoku University Hospital)
none
Self funding
NO
2012 | Year | 02 | Month | 21 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 18 | Day |
2011 | Year | 11 | Month | 18 | Day |
2012 | Year | 02 | Month | 01 | Day |
2016 | Year | 11 | Month | 30 | Day |
2012 | Year | 02 | Month | 21 | Day |
2019 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008656
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