UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011175 |
|---|---|
| Receipt number | R000012866 |
| Scientific Title | Re-induction for loss of response or non-response with adalimumab every other week-Ruby study |
| Date of disclosure of the study information | 2013/07/11 |
| Last modified on | 2016/06/02 23:51:51 |
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Basic information
Public title
Re-induction for loss of response or non-response with adalimumab every other week-Ruby study
Acronym
Re-induction for loss of response or non-response with adalimumab every other week-Ruby study
Scientific Title
Re-induction for loss of response or non-response with adalimumab every other week-Ruby study
Scientific Title:Acronym
Re-induction for loss of response or non-response with adalimumab every other week-Ruby study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of re-induction therapy with adalimumab for loss of response or non-response to adalimumab in Crohn's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission rate at week 12 (Remission: CDAI<150)
Key secondary outcomes
(1) Serial change of CDAI
(Remission rate, Decreasing ratio from baseline, Clinical response 50,70,100)
(2) Serial change of CRP level
(3) Antibody against adalimumab
(4) Level of adalimumab concentration
(5) Mucosal healing rate at week 26
(6) Adverse event
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
Adalimubab is administered 160 mg at week 0, 80 mg at week 2, 40 mg every other week from week 4.
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
Active Crohn's disease patients who have inadequate efficacy of adalimumab therapy after 6 weeks
(1) More than 150 points of CDAI
(2) Patients who had changed dosage and administration of other medication for Crhon's disease just before 3 months of obtained the informed concent
Key exclusion criteria
(1) Patients < 15 years of age
(2) Patients who are pregnant or likely to be pregnant women
(3) Patients with severe infection
(4) Patients who underwent surgery within 3 months
(5) Patients with severe intestinal structures
(6) Patients with malignancy
(7) Patients not approving the study consent
(8) Patients judged as inappropriate for enrollment by physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakase |
Organization
Kyoto University Hospital
Division name
Division of Endoscopic Medicine
Zip code
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Matsuura |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-4319
Homepage URL
minomats@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Departments of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Graduate School of Medical Science
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
京都大学医学部附属病院（京都府）、京都府立医科大学（消化器内科）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 11 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 05 | 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
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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