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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000023871
Date of registration:	01/09/2016
Prospective Registration:	No
Primary sponsor:	Fukuoka University Chikushi Hospital
Public title:	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) - Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study)
Date of first enrolment:	2016/08/25
Target sample size:	100
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027495
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Teruyuki Takeda
Address:	1-1-1,Zokumyoin, Chikushino, Fukuoka 818-8502 Japan
Telephone:	092-921-1011
Email:	take5times@hotmail.co.jp
Affiliation:	Fukuoka University Chikushi Hospital Inflammatory Bowel Disease Center

Name:	Fumihito Hirai
Address:	1-1-1,Zokumyoin, Chikushino, Fukuoka Japan
Telephone:	092-921-1011
Email:	fuhirai@cis.fukuoka-u.ac.jp
Affiliation:	Fukuoka University Chikushi Hospital Inflammatory Bowel Disease Center

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Patients who have symptomatic stenosis Patients who have fistula Patients who are considered inadequate by investigator

Age minimum: 16years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

Administration of Adalimumab 80 mg every 2 weeks.
Administration of Adalimumab 40 mg every week.

Primary Outcome(s)

Harvey Bradshaw Index remission (<4) rate at week 52

Secondary Outcome(s)

Serum ADA/AAA concentration at baseline and week 52 Safety profile through 52 weeks

Secondary ID(s)

Source(s) of Monetary Support

Fukuoka University Chikushi Hospital

None

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 25/08/2016
Contact:

chikushirinnsho@adm.fukuoka-u.ac.jp

Fukuoka University Chikushi Hospital

092-921-1011

chikushirinnsho@adm.fukuoka-u.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2019
URL:

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