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

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 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

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

Value
https://center6.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