UMIN-CTR Clinical Trial

Basic information
Public title	Inception Cohort Registry Study of Patients with Crohn's disease
Acronym	CD Registry Study
Scientific Title	Inception Cohort Registry Study of Patients with Crohn's disease
Scientific Title:Acronym	CD Registry Study
Region	Japan

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

Objectives
Narrative objectives1	To understand the characteristics of Crohn's disease(CD) treatment in actual clinical settings by recording the treatment patterns after diagnosis of CD, the continuity of each treatment, patient characteristics and the surgery status in CD patients in actual clinical settings.
Basic objectives2	Others
Basic objectives -Others	To explore the factors related to treatment decisions and good outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of proportion(%)of patients using each CD treatment after CD diagnosis.
Key secondary outcomes	1.Time to start using a biological drug from CD diagnosis 2.Duration of each CD treatment, Time to next CD treatment 3.Time to CD-related surgery from CD diagnosis 4.Change in HBI score in 4 years 5.Change in QOL indices (FACIT-Fatigue, short inflammatory bowel disease questionnaire[SIBDQ], and work productivity and activity impairment questionnaire: General Health[WPAI:GH])in 4 years. 6.Adverse events in each drug therapy for CD

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.Men and women aged over 16 years. 2.Pstients newly given a CD diagnosis according to MHLW criteria on or after June 1,2016. 3.Each subject must sign an Informed Consent Form(ICF) indicating that subject understands the purpose of and procedures required for the study and are willing to participate in the study.(if the subject is minor, informed assent might be obtained from each study subject according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF).
Key exclusion criteria	1.Patients who have used a biological drug having an indication for auto-immune diseases before diagnosis of CD 2.Patients with unknown dates (month and year) of CD diagnosis. 3.Patients currently enrolled or expected to be enrolled in other registration trial(s) at the registry entry.
Target sample size	900

Research contact person
Name of lead principal investigator	1st name Rami Middle name Last name Suzuki
Organization	Janssen Pharma K.K.
Division name	Medical Affairs Division
Zip code	1010065
Address	3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo 101-0065
TEL	03-4411-7700
Email	rsuzuk19@its.jnj.com

Public contact
Name of contact person	1st name Yutaro Middle name Last name Kawagoe
Organization	EP-CRSU Co., Ltd
Division name	Project Management Promotion Department
Zip code	1620814
Address	Acropolis Tokyo, 6-29 Shin-ogawa-cho, Shinjuku-ku, Tokyo 162-0814
TEL	03-6759-9904
Homepage URL
Email	kawagoe226@eps.co.jp

Sponsor
Institute	Janssen Pharma K.K.
Institute
Department

Funding Source
Organization	Janssen Pharma K.K.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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	JA北海道厚生連札幌厚生病院（北海道）、札幌医科大学附属病院（北海道）、慶應義塾大学病院（東京都）、東邦大学医療センター佐倉病院（千葉県）、東京医科歯科大学医学部附属病院（東京都）、北里大学北里研究所病院（東京都）、東京慈恵会医科大学附属病院（東京都）、杏林大学医学部付属病院（東京都）、横浜市立大学市民総合医療センター（神奈川県）、四日市羽津医療センター（三重県）、大阪大学医学部附属病院（大阪府）、兵庫医科大学病院（兵庫県）、九州大学病院（福岡県）、福岡大学筑紫病院（福岡県）、藤田医科大学病院（愛知県）、東北大学病院（宮城県）、徳洲会札幌東徳洲会病院（北海道）、滋賀医科大学医学部附属病院（滋賀県）、岩手医科大学附属病院（岩手県）、富山県立中央病院（富山県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 09 Day
Date of IRB	2018 Year 07 Month 23 Day
Anticipated trial start date	2018 Year 07 Month 23 Day
Last follow-up date	2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Inception Cohort Registry Study

Management information
Registered date	2018 Year 04 Month 13 Day
Last modified on	2020 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036758