UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis
Title of the study (Brief title)	ADVENTURE study
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyzed adalimumab of short and long-term effectiveness and safety in multicenter cohort study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	proportion of patients achieving clinical response at week 8.
Key secondary outcomes	i)overall 1)Rate of clinical remission at week 2,4,8,12. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Rate of operation at week 12. 4)Rate of ongoing adalimumab treatment at week 12. 5)Rate of corticosteroid discontinuation at week 12. ii)The patients who were injected adalimumab from 24 August 2013 to 30 July 2016. 1)Rate of clinical remission at week 2,4,8,12 and 24,36,52. 2)Rate of clinical response at week 2,4,8,12 and 24,36,52. 3)Cumulative operation rate at week 52. 4)Cumulative ongoing adalimumab treatment rate at week 52. 5)Cumulative response rate at week 52. 6)Cumulative remission rate at week 52. 7)Rate of corticosteroid discontinuation at week 52. 8)Adverse event. etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis were treated adalimumab between July 2013 and March 2017
Key exclusion criteria	1) 2)Parial Mayo score 2 or less at baseline. 3)Not conforming to the packege insert of adalimumab until 4 weeks. 4)Patients who underwent colectomy. 5)The patints who treated with anti-TNF antibody excepted Infliximab.
Target sample size	100

Research contact person
Name of lead principal investigator	Tanaka Hiroki
Organization	Sapporo kosei general hospital
Division name	IBD center
Address	8-5, Kita3jo higashi, Chuo-ku, Sapporo city, Hokkaido, 060-0033, Japan
TEL	011-261-5331
Email	hirokit@mtc.biglobe.ne.jp

Public contact
Name of contact person	Sakemi Ryosuke
Organization	Tobatakyoritu hospital
Division name	Department of Gastroenterology
Address	2-5-1 Sawami, Tobata-ku, Kitakyusyu city, Fukuoka, 804-0093, Japan
TEL	093-871-5422
Homepage URL
Email	ryosuke.s.1980@gmail.com

Sponsor
Institute	Sapporokosei general hospital
Institute
Department

Funding Source
Organization	There is no organization
Organization
Division
Category of Funding Organization	Other
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 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 07 Day
Anticipated trial start date	2017 Year 11 Month 01 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	None

Management information
Registered date	2017 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032064