UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030988 |
|---|---|
| Receipt number | R000035381 |
| Scientific Title | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/01/25 12:59:22 |
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Basic information
Public title
Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy
Acronym
Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)
Scientific Title
Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy
Scientific Title:Acronym
Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study)
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of maintenance therapy by azathioprine versus adalimumab after induction of tacrolimus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of non-relapse rates (1 year) between azathioprine group and adalimumab group
Key secondary outcomes
Comparison of side-effect rates (1 year) between azathioprine group and adalimumab group
Comparison of clinical remission rates (1 year) between azathioprine group and adalimumab group
Comparison of endoscopic remission rates (1 year) between azathioprine group and adalimumab group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induce azathioprine and continue maintenance therapy by azathioprine
Interventions/Control_2
Induce adalimumab and continue maintenance therapy by adalimumab
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
Moderate to severe ulcerative colitis patients who are refractory to steroid therapy
No history of immunomodulator, anti-TNF drug or calcineurin inhibitor within 1 year
Key exclusion criteria
Patients who are contraindicated of tacrolimus, azathioprine or adalimumab
Female patients who are in lactation or desire to bear children
Patients less than 15 years old
Patients who do not consent to the trial
Patients who had malignancy
Patients who had intestinal resection within 6 months
Patients who are short-bowel syndrome
Patients who are not appropriate to participate to the trial
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Suzuki |
Organization
Sakura Medical Center, Toho university
Division name
Inflammatory bowel disease (IBD) center
Zip code
Address
564-1, Shimoshizu, Sakura, Chica
TEL
043-462-8811
yasuo-suzuki@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Suzuki |
Organization
Sakura Medical Center, Toho university
Division name
Inflammatory bowel disease (IBD) center
Zip code
Address
564-1, Shimoshizu, Sakura, Chica
TEL
043-462-8811
Homepage URL
yasuo-suzuki@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Sakura Medical Center, Toho university
Institute
Department
Personal name
Funding Source
Organization
Sakura Medical Center, Toho university
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
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
| 2018 | Year | 02 | 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
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035381
