UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018082 |
|---|---|
| Receipt number | R000020928 |
| Scientific Title | Understanding the Impact of Ulcerative COlitis aNd Its AssoCiated disease burdeN on patlents |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2017/12/26 09:29:21 |
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Basic information
Public title
Understanding the Impact of Ulcerative COlitis aNd Its AssoCiated disease burdeN on patlents
Acronym
ICONIC study
Scientific Title
Understanding the Impact of Ulcerative COlitis aNd Its AssoCiated disease burdeN on patlents
Scientific Title:Acronym
ICONIC study
Region
| Japan | North America | South America |
| Europe | Africa |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To increase the understanding of the disease burden associated with UC, to enable improved UC management and understanding.
Basic objectives2
Others
Basic objectives -Others
QOL assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate PRISM as an assessment tool for perceived disease associated suffering in UC patients, by assessing correlation with SIBDQ and PHQ-9, according to geographical location and disease severity
Key secondary outcomes
-To describe the multi-faceted burden of disease in recently diagnosed UC patients
-To investigate the correlation between patient and physician perception of UC disease through the use of the PRISM and SCCAI tools
-To estimate resource utilization associated with UC and investigate the correlation between this and evaluated burden of disease
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients aged more than18 years who have been diagnosed with UC < 12 months prior to study inclusion
-Female or male
-Speaks the language of the provided patient questionnaire
-Signed a patient authorization form to use and disclose personal health information
Key exclusion criteria
Patients without agreement
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susuumu Adachi |
Organization
AbbVie GK
Division name
Medical
Zip code
Address
3-5-27, Minato-ku, Tokyo
TEL
03-4577-9348
susumu.adachi@abbvie.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Kawai |
Organization
Abbvie GK
Division name
Medical
Zip code
Address
3-5-27, Mita, Minato-ku
TEL
090-6012-3907
Homepage URL
yumi.kawai@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Disease burden of Ulcerative Colitis, Prospective study
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020928
