UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020840
Receipt No. R000023914
Scientific Title A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients
Date of disclosure of the study information 2016/02/02
Last modified on 2019/02/05

* 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 A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients
Acronym ROSE Study
Scientific Title A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients
Scientific Title:Acronym ROSE Study
Region
Japan

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

Objectives
Narrative objectives1 To verify the possibility of discontinuation of adalimumab therapy without relapse for a year in ulcerative patients with adalimumab-induced remission.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of sustained remission after discontinuation of adalimumab therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 discontinuation of adalimumab therapy
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with adalimumab-induced remission for more than 6 months
(1)Partial Mayo score is 2 points or less , with no individual subscore exceeding 1 point
(2)Negative CRP
2.Patients with informed consent for this study by document
Key exclusion criteria 1.Patients with serious infection (sepsis etc.)
2.Patients with active tuberculosis
3.Patients with a history of hypersensitivity to any of the ingredients of Humira
4.Patients with a current or past history of demyelinating diseases (multiple sclerosis, etc.)
5.Patients with congestive heart failure
6.Patients with pregnancy or desiring for pregnancy
7.Patients with history of colectomy
8.Patients without informed consent
9.Patients who are considered ineligible for this study by the principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Toyokawa
Organization Fukuyama Medical Center
Division name Department of Gastroenterology
Zip code
Address 4-14-17 Okinogamicho, Fukuyama City, Hiroshima
TEL 084-922-0001
Email toyotatu@kmail.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Toyokawa
Organization Fukuyama Medical Center
Division name Department of Gastroenterology
Zip code
Address 4-14-17 Okinogamicho, Fukuyama City, Hiroshima
TEL 084-922-0001
Homepage URL
Email toyotatu@kmail.plala.or.jp

Sponsor
Institute Fukuyama Medical Center
Institute
Department

Funding Source
Organization Fukuyama Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 02 Month 02 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 Enrolling by invitation
Date of protocol fixation
2015 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 02 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023914

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.