UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tight control for the anti- TNF alpha antibody- treated CD (Crohn's disease) patients with thiopurine intensification determined by the capsule endoscopic appearances of small intestinal rejoins
Title of the study (Brief title)	Tactics study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Medicine in general Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of thiopuirine derivatives to anti-TNF alpha antibody- treated CD patients with small intesitinal involvements evaluated by capsule endoscopiy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	improvement ratio of small intestinal regions evaluated by CECDAI at 6 months
Key secondary outcomes	mucosal healing rates of small intestinal regions at 6 months serum CRP titer at 6 months serum anti-TNF alpha concentration at 6 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	thiopurine derivatives
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	anti-TNF alpha antibody treated CD patients without steroids whose CDAI titer is below 150 patients with informed consents
Key exclusion criteria	patients refractory with infliximab and adalimumab patients refractory with thiopurine derivatives patients whose WBC titer is under 3000/mm3 pregnant patients patients in the lactation patients has past history of malignancy patients who in not suitable to this study determined by doctors
Target sample size	50

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 City, 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	1981 Kamoda, Kawagoe City, 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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 28 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 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 02 Month 05 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=R000015264