Unique ID issued by UMIN | UMIN000009284 |
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Receipt number | R000010904 |
Scientific Title | The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients |
Date of disclosure of the study information | 2012/11/20 |
Last modified on | 2019/05/14 11:28:28 |
The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients
The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease
The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients
The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease
Japan |
Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)
Medicine in general | Gastroenterology | Gastrointestinal surgery |
Adult |
Others
NO
The aim of this study is to evaluated the efficacy of adalimumab maintenance therapy for post-operative Crohn's disease.
Efficacy
Phase II
remission maintenance rate of adalimumab maintenance therapy ,evaluated by CDAI score 12months after intestinal resection.
remission maintenance rate 6months and 12months after intestinal resection, evaluated by CDAI score and C-reactive protein. remission maintenae rate 6months and 12months after intestinal resection, evaluated by endoscopic score(Rutgeerts score)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.
18 | years-old | <= |
65 | years-old | >= |
Male and Female
patients after surgical removal of Crohn's disease lesions(intestinal resection)
patients enrolled endoscopy 6months and 12months after surgery
1the patient of contraindication for adalimumab
2pregnancy
3the patient who is short bowel syndrome
4the patient who is not able to calculate CDAI
5the patient with stoma
6the case which is hard to get the patient's consent
7the patient who was judged for insuitable by responsibility doctor
20
1st name | Yasuo |
Middle name | |
Last name | Suzuki |
Sakura Medical center,Toho University
IBD center
2858741
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
yasuo-suzuki@sakura.med.toho-u.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Yamada |
Sakura Medical Center,Toho University
Internal medicine
2858741
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
Sakura Medical Center,Toho university
none
Self funding
Ethics committee, Sakura Medical Center,Toho university
564-1,shimoshizu,sakura
0434628811
taro-dog@sakura.med.toho-u.ac.jp
NO
2012 | Year | 11 | Month | 20 | Day |
Waiting for enforcement
Partially published
Waiting for enforcement
clinical remission rate at 12months was 70.0%
endoscopic remission rate at 12months was 62.5%
2019 | Year | 05 | Month | 14 | Day |
post-operative Crohn's disease patients
Hospitalization at the relevant facility, operation example
Severe adverse events of hemorrhage, white blood cell count decrease and sepsis were seen
The endoscopic remission was assessed by Rutgeerts score, clinical remission assessed by Crohn's disease activity index (CDAI).
Completed
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 10 | Month | 10 | Day |
2012 | Year | 11 | Month | 20 | Day |
2014 | Year | 11 | Month | 19 | Day |
2012 | Year | 11 | Month | 07 | Day |
2019 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010904
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