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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023871
Receipt No. R000027495
Scientific Title Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Date of disclosure of the study information 2016/09/01
Last modified on 2017/02/15

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

Public contact
1st name of contact person
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chikushi Hospital
Division name Inflammatory Bowel Disease Center
Zip code
Address 1-1-1,Zokumyoin, Chikushino, Fukuoka
TEL 092-921-1011
Homepage URL
Email fuhirai@cis.fukuoka-u.ac.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
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 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 02 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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