UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of infliximab therapy for refractory pouchitis
Title of the study (Brief title)	Infliximab therapy for refractory pouchitis
Region	Japan

Condition
Condition	ulcerative colitis, pouchitis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of infliximab therapy for refractory pouchitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Efficacy of infliximab treatment will be assessed with pouchitis disease activity index before and after treatment
Key secondary outcomes	Evaluate the association between dose of anti-TNF alpha before treatment and efficacy of treatment

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	infliximab
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with refractory pouchitis after restorative proctocolectomy for ulcerative colitis
Key exclusion criteria	Patients with pre-existed malignancy, other infectious disease, heart failure, or infusion reaction for infliximab
Target sample size	10

Research contact person
Name of lead principal investigator	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Inflammatory bowel disease center
Address	1-1 mukogawacho Nishinomiya Hyogo Japan
TEL	0798-45-6111
Email	uchino2s@hyo-med.ac.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Inflammatory bowel disease center
Address	1-1Mukogawacho Nishinomiya Hyogo Japan
TEL	0798-45-6371
Homepage URL
Email	uchino2s@hyo-med.ac.jp

Sponsor
Institute	Inflammatory bowel disease center, Hyogo college of medicine
Institute
Department

Funding Source
Organization	Hyogo college of medicine
Organization
Division
Category of Funding Organization	Self funding
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	兵庫医科大学（兵庫県），Hyogo college of medicine

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 05 Day
Anticipated trial start date	2013 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 03 Month 07 Day
Last modified on	2016 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012736