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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-UMIN000012790
Date of registration:	01/02/2014
Prospective Registration:	Yes
Primary sponsor:	Saitama Medical center
Public title:	Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease
Scientific title:	Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease - CADELLAC study
Date of first enrolment:	2014/02/01
Target sample size:	20
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014942
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Shingo Kato
Address:	981 Kamoda, Kawagoe, Saitama Japan
Telephone:	049-228-3564
Email:	skato@saitama-med.ac.jp
Affiliation:	Saitama Medical center Department of gastroenterology and Hepatology

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

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: patients with contraindication of infliximab patients with pregnancy and lactation patients without informed consent patients under and after treatment of malignancy

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Crohn's disease

Intervention(s)

dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months

Primary Outcome(s)

mucosal healing rates at 6 months

Secondary Outcome(s)

mucosal healing rates at 12 months improvement of mucosal regions at 6 and 12 months serum CRP titer at 6 and 12 months stool calprotectin titer at 6 and 12 months stool PTX3 titer at 6 and 12 months safety

Secondary ID(s)

Source(s) of Monetary Support

Saitama Medical center

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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