UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019512
Receipt number R000022476
Scientific Title Efficacy of Humira(Adalimumab) in patients with moderate to severe ulcerative colitis (KyuSyu IBD project)
Date of disclosure of the study information 2015/10/27
Last modified on 2017/04/28 09:11:43

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Basic information

Public title

Efficacy of Humira(Adalimumab)
in patients with moderate to severe
ulcerative colitis
(KyuSyu IBD project)

Acronym

HAWKS study

Scientific Title

Efficacy of Humira(Adalimumab)
in patients with moderate to severe
ulcerative colitis
(KyuSyu IBD project)

Scientific Title:Acronym

HAWKS study

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the short- and
long-term therapeutic outcome,
of adalimumab in moderate to severe ulcerative colitis
in dairy practice. In addition,
to examine the factors for
short- and long-term efficacy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Short-term therapeutic outcome
(Remission rate after 8 weeks)
2.Long-term therapeutic outcome
(Remission rate after 52 weeks)

Key secondary outcomes

1. Short-term therapeutic outcome
(Response rate and mucosal healing
rate after 8 weeks)
2.Long-term therapeutic outcome
(Response rate and mucosal healing
rate after 52 weeks)
3.The factors for short-
and long-term therapeutic outcome
4.Cumulative non-relapse and
non-operation rate during 52 weeks
5.The factors for
cumulative non-relapse and non-
-operation rate


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

Patients with moderate to severe
ulcerative colitis who administrate of
adalimumab.

Key exclusion criteria

1.Patients who
Contraindicate for adalimumab.
2.Patients who can not provide
informed consent.
3.Patients who have malignancy
4.Patients who judged to be
disqualified by the physician

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyuki Matsui MD.PhD.

Organization

Fukuoka University Chikushi
Hospital

Division name

Department of Gastroenterology

Zip code


Address

Zokumyoin 1-1-1, Chikushino,

TEL

092-921-1011

Email

matsui@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumihito Hirai MD.PhD.

Organization

Fukuoka University Chikushi

Division name

Department of Gastroenterology

Zip code


Address

Zokumyoin 1-1-1, Chikushino,

TEL

092-921-1011

Homepage URL


Email

fuhirai@cis.fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University

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


Name of secondary funder(s)



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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 27 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

Enrolling by invitation

Date of protocol fixation

2013 Year 12 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 05 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 06 Month 30 Day

Date trial data considered complete

2017 Year 06 Month 30 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information

To examine the factors (History of medication, Disease activity,
Concomitant medication etc.)
relate to the 8 or 52 weeks
remission and response.


Management information

Registered date

2015 Year 10 Month 27 Day

Last modified on

2017 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name