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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name