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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-UMIN000006232
Date of registration:	01/09/2011
Prospective Registration:	Yes
Primary sponsor:	Saitama Medical University
Public title:	Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab
Scientific title:	Evaluation of efficacy of high dose infliximab with azathiopurine add-on therapy for patients with Crohn's disease refractory to low dose infliximab - High dose infliximab with azathiopurine add-on therapy
Date of first enrolment:	2011/10/01
Target sample size:	40
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007377
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Shingo Kato
Address:	1981 Kamoda, Kawagoe City, Saitama Japan
Telephone:	049-228-3564
Email:	skato@saitama-med.ac.jp
Affiliation:	Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

Name:	Shingo Kato
Address:	1981 Kamoda, Kawagoe City, Saitama Japan
Telephone:	049-228-3564
Email:	skato@saitama-med.ac.jp
Affiliation:	Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: patients who cannot been kept in the treatment with infliximab and who cannot been treated with azathiopurine patients in lactate state patient whose age below 15 years old and above 70 years old patients who cannot agree with this study patients who had been treated with open surgery within 6 months patients with short bowel syndrome patients who was determined not to be appropriate in participation in this study

Age minimum: 15years-old
Age maximum: 70years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

treatment with high dose infliximab and azathiopurine(6MP can be used in case of refractory patients to azatioupurine)
treatment with only high dose infliximab

Primary Outcome(s)

Remission rate in 24 week

Secondary Outcome(s)

Remission rates in each state CR70, CR100 Mucosal healing rates in 24, 48 week Loss of response rate Relapse rate Safety

Secondary ID(s)

Source(s) of Monetary Support

Saitama Medical University

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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