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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009284
Receipt No. 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

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Basic information
Public title The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients
Acronym The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease
Scientific Title The Study for Efficacy of Adalimumab Maintenance Therapy Initiated Following Resection of Active Lesions in Crohn's Disease Patients
Scientific Title:Acronym The Efficacy of Adalimumab Maintenance Therapy for Post-Operative Crohn's Disease
Region
Japan

Condition
Condition Crohn's disease Patients who has been treated with following surgical removal of active lesions(intestinal resection)
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluated the efficacy of adalimumab maintenance therapy for post-operative Crohn's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes remission maintenance rate of adalimumab maintenance therapy ,evaluated by CDAI score 12months after intestinal resection.
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 adalimumab injected immediately(within 3months) after surgical removal Crohn's disease lesions(intestinal resection). Inject SC 160mg,80mg,40mg in every other week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria patients after surgical removal of Crohn's disease lesions(intestinal resection)
patients enrolled endoscopy 6months and 12months after surgery
Key exclusion criteria 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
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Suzuki
Organization Sakura Medical center,Toho University
Division name IBD center
Zip code 2858741
Address 564-1,Shimoshizu,Sakura-city,Chiba
TEL 043-462-8811
Email yasuo-suzuki@sakura.med.toho-u.ac.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Yamada
Organization Sakura Medical Center,Toho University
Division name Internal medicine
Zip code 2858741
Address 564-1,Shimoshizu,Sakura-city,Chiba
TEL 043-462-8811
Homepage URL
Email taro-dog@sakura.med.toho-u.ac.jp

Sponsor
Institute Sakura Medical Center,Toho university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee, Sakura Medical Center,Toho university
Address 564-1,shimoshizu,sakura
Tel 0434628811
Email taro-dog@sakura.med.toho-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 20 Day

Related information
URL releasing protocol Waiting for enforcement
Publication of results Partially published

Result
URL related to results and publications Waiting for enforcement
Number of participants that the trial has enrolled
Results
clinical remission rate at 12months was 70.0%
endoscopic remission rate at 12months was 62.5%
Results date posted
2019 Year 05 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
post-operative Crohn's disease patients
Participant flow
Hospitalization at the relevant facility, operation example
Adverse events
Severe adverse events of hemorrhage, white blood cell count decrease and sepsis were seen
Outcome measures
The endoscopic remission was assessed by Rutgeerts score, clinical remission assessed by Crohn's disease activity index (CDAI).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
2012 Year 10 Month 10 Day
Anticipated trial start date
2012 Year 11 Month 20 Day
Last follow-up date
2014 Year 11 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 07 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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