UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Pilot study of Infliximab Dose-intensification determined by Capsule Endoscopic Evaluation of Small Intestinal Involvements in Patients with Crohn's Disease
Title of the study (Brief title)	CADELLAC study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of infliximab dose intensification determined by capsule endoscopic evaluation of small intestinal involvements for 6 months steroid-free patients with CDAI acore whinch was no more than 150
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mucosal healing rates at 6 months
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dose intensification of 10mg/kg infliximab with additional treatment with thiopurines in case of aggravation at 6 months
Interventions/Control_2
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	6 months steroid free CD patients with CDAI which was no more than 150
Key exclusion criteria	patients with contraindication of infliximab patients with pregnancy and lactation patients without informed consent patients under and after treatment of malignancy
Target sample size	20

Research contact person
Name of lead principal investigator	Shingo Kato
Organization	Saitama Medical center
Division name	Department of gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe, Saitama
TEL	049-228-3564
Email	skato@saitama-med.ac.jp

Public contact
Name of contact person	Shingo Kato
Organization	Saitama Medical center
Division name	Department of gastroenterology and Hepatology
Address	981 Kamoda, Kawagoe, Saitama
TEL	049-228-3564
Homepage URL
Email	skato@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical center
Institute
Department

Funding Source
Organization	Saitama Medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 31 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 08 Day
Last modified on	2018 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014942