UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020840 |
|---|---|
| Receipt number | 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 | 2023/02/08 14:16:39 |
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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 | Toyokawa |
| Middle name | |
| Last name | Toyokawa |
Organization
Fukuyama Medical Center
Division name
Department of Gastroenterology
Zip code
720-8520
Address
4-14-17 Okinogamicho, Fukuyama City, Hiroshima
TEL
084-922-0001
toyotatu@kmail.plala.or.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Toyokawa |
Organization
Fukuyama Medical Center
Division name
Department of Gastroenterology
Zip code
720-8520
Address
4-14-17 Okinogamicho, Fukuyama City, Hiroshima
TEL
084-922-0001
Homepage URL
toyotatu@kmail.plala.or.jp
Sponsor or person
Institute
Fukuyama Medical Center
Institute
Department
Personal name
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
same as above
Address
same as above
Tel
same as above
same as above
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
| 2018 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023914
