UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014708 |
|---|---|
| Receipt number | 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 | 2022/10/03 13:42:53 |
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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
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
hirokit@mtc.biglobe.ne.jp
Sponsor or person
Institute
IBD Center, Sapporo Kosei General Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
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
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017097
