UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Understanding the Impact of Ulcerative COlitis aNd Its AssoCiated disease burdeN on patlents
Title of the study (Brief title)	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	Susuumu Adachi
Organization	AbbVie GK
Division name	Medical
Address	3-5-27, Minato-ku, Tokyo
TEL	03-4577-9348
Email	susumu.adachi@abbvie.com

Public contact
Name of contact person	Yumi Kawai
Organization	Abbvie GK
Division name	Medical
Address	3-5-27, Mita, Minato-ku
TEL	090-6012-3907
Homepage URL
Email	yumi.kawai@abbvie.com

Sponsor
Institute	AbbVie GK
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020928