UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029030 |
|---|---|
| Receipt number | R000032064 |
| Scientific Title | Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/09/06 19:56:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis
Acronym
ADVENTURE study
Scientific Title
Adalimumab multicenter cohort study of the effectiveness for patients with Ulcerative colitis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tanaka Hiroki |
Organization
Sapporo kosei general hospital
Division name
IBD center
Zip code
Address
8-5, Kita3jo higashi, Chuo-ku, Sapporo city, Hokkaido, 060-0033, Japan
TEL
011-261-5331
hirokit@mtc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakemi Ryosuke |
Organization
Tobatakyoritu hospital
Division name
Department of Gastroenterology
Zip code
Address
2-5-1 Sawami, Tobata-ku, Kitakyusyu city, Fukuoka, 804-0093, Japan
TEL
093-871-5422
Homepage URL
ryosuke.s.1980@gmail.com
Sponsor or person
Institute
Sapporokosei general hospital
Institute
Department
Personal name
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)
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
| 2017 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 07 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032064
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
