UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023871 |
|---|---|
| Receipt number | 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 | 2020/03/17 11:33:30 |
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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
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
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
take5times@hotmail.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027495
