UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Humira(Adalimumab) in patients with moderate to severe ulcerative colitis (KyuSyu IBD project)
Title of the study (Brief title)	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	Toshiyuki Matsui MD.PhD.
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Address	Zokumyoin 1-1-1, Chikushino,
TEL	092-921-1011
Email	matsui@fukuoka-u.ac.jp

Public contact
Name of contact person	Fumihito Hirai MD.PhD.
Organization	Fukuoka University Chikushi
Division name	Department of Gastroenterology
Address	Zokumyoin 1-1-1, Chikushino,
TEL	092-921-1011
Homepage URL
Email	fuhirai@cis.fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka 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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 12 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022476