UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Acronym	Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Scientific Title	Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Scientific Title:Acronym	Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy and safety of Adalimaumb 80mg EOW and 40mg EW.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Harvey Bradshaw Index remission (<4) rate at week 52
Key secondary outcomes	Serum ADA/AAA concentration at baseline and week 52 Safety profile through 52 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of Adalimumab 80 mg every 2 weeks.
Interventions/Control_2	Administration of Adalimumab 40 mg every week.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Crohn's disease patients who lost response (HBI>4) under adalimumab 40mg EOW treatment.
Key exclusion criteria	Patients who have symptomatic stenosis Patients who have fistula Patients who are considered inadequate by investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Fumihito Middle name Last name Hirai
Organization	Fukuoka University Chikushi Hospital
Division name	Inflammatory Bowel Disease Center
Zip code	818-8502
Address	1-1-1,Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Email	fuhirai@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Teruyuki Middle name Last name Takeda
Organization	Fukuoka University Chikushi Hospital
Division name	Inflammatory Bowel Disease Center
Zip code	818-8502
Address	1-1-1,Zokumyoin, Chikushino, Fukuoka
TEL	092-921-1011
Homepage URL
Email	take5times@hotmail.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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

IRB Contact (For public release)
Organization	Fukuoka University Chikushi Hospital
Address	1-1-1,Zokumyoin, Chikushino, Fukuoka
Tel	092-921-1011
Email	chikushirinnsho@adm.fukuoka-u.ac.jp

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	福岡大学筑紫病院（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 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	Terminated
Date of protocol fixation	2016 Year 08 Month 26 Day
Date of IRB	2016 Year 08 Month 25 Day
Anticipated trial start date	2016 Year 08 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027495