UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032237 |
|---|---|
| Receipt number | R000036758 |
| Scientific Title | Inception Cohort Registry Study of Patients with Crohn's disease |
| Date of disclosure of the study information | 2018/04/13 |
| Last modified on | 2020/10/14 13:50:53 |
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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
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
kawagoe226@eps.co.jp
Sponsor or person
Institute
Janssen Pharma K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036758
