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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014708
Receipt No. R000017097
Scientific Title Evaluation of Long-term efficacy, safety and predictors of Adalimumab in Crohn's disease: Japanese multicenter cohort study (ADJUST study)
Date of disclosure of the study information 2014/07/30
Last modified on 2015/07/29

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Basic information
Public title Evaluation of Long-term efficacy, safety and predictors of Adalimumab in Crohn's disease: Japanese multicenter cohort study (ADJUST study)
Acronym Evaluation of Adalimumab in Crohn's disease
Scientific Title Evaluation of Long-term efficacy, safety and predictors of Adalimumab in Crohn's disease: Japanese multicenter cohort study (ADJUST study)
Scientific Title:Acronym Evaluation of Adalimumab in Crohn's disease
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the long-term efficacy, safety and the predictors of Adalimumab in Crohn's disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Rate of ongoing adalimumab treatment.
Key secondary outcomes Rate of ongoing adalimumab treatment and the predictors.
Rate of non ileo-colonic resection after adalimumab treatment and the predictors.
Reason of adalimumab drop out.
Adverse event.
etc

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the Crohn's disease patients who were injected adalimumab from 27 October 2010 to 31 December 2013.
Key exclusion criteria Nothing
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Tanaka
Organization Sapporo Kosei General Hospital
Division name IBD Center
Zip code
Address N3, E8, Chuo-ku, Sapporo, 060-0033
TEL 011-261-5331
Email hirokit@mtc.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Tanaka
Organization Sapporo Kosei General Hospital
Division name IBD Center
Zip code
Address N3, E8, Chuo-ku, Sapporo, 060-0033
TEL 011-261-5331
Homepage URL
Email hirokit@mtc.biglobe.ne.jp

Sponsor
Institute IBD Center, Sapporo Kosei General Hospital
Institute
Department

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

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 札幌厚生病院(北海道)、北里大学北里研究所病院(東京都)、東京山手メディカルセンター(東京都)、東京医科歯科大学(東京都)、東邦大学医療センター佐倉病院(千葉県)、大阪市立大学(大阪府)、大阪大学(大阪府)、滋賀医科大学(滋賀県)、京都大学(京都府)など

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 30 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
2015 Year 02 Month 28 Day
Date trial data considered complete
2015 Year 02 Month 28 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information Observational study

Management information
Registered date
2014 Year 07 Month 30 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017097

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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