UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study of corticosteroids for inflammatory bowel disease
Title of the study (Brief title)	Prospective cohort study of corticosteroids for inflammatory bowel disease
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate effectiveness evaluation of PSL for inflammatory bowel disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rates of 8 weeks after corticosteroids
Key secondary outcomes	Response rates at 30 weeks and 54 weeks after corticosteroids Remission rates at 8, 30 weeks and 54 weeks after corticosteroids The incidence of adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)patients of ulcerative colitis or Crohn disease 2)Partial Mayo score above2 or CDAI above149 3)with agreement
Key exclusion criteria	1)colitis other than ulcerative colitis or Crohn disease 2)patients who have symptomatic gastrointestinal stenosis 3)patients who destine to undergo colectomy 4)serious infectious disease 5)patients who investigators and subinvestigators consider to be inappropriate to participate in this study
Target sample size	600

Research contact person
Name of lead principal investigator	Makoto Naganuma
Organization	Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Email	nagamakoto@z7.keio.jp

Public contact
Name of contact person	Makoto Mutaguchi
Organization	Keio University
Division name	Gastroenterology and Hepatology
Address	35 Shinano-machi, Shinjyu-ku , Tokyo
TEL	03-3353-1211
Homepage URL
Email	m.mutaguchi@keio.jp

Sponsor
Institute	Keio University Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	self funing
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 22 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	Prospective cohort study

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2018 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029555