UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013788 |
|---|---|
| Receipt number | R000015745 |
| Scientific Title | Relation between Efficacy of Adalimumab and Pharmacokinetics in Ulcerative colitis. |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2018/11/20 21:55:12 |
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Basic information
Public title
Relation between Efficacy of Adalimumab and Pharmacokinetics in Ulcerative colitis.
Acronym
REAL Study
Scientific Title
Relation between Efficacy of Adalimumab and Pharmacokinetics in Ulcerative colitis.
Scientific Title:Acronym
REAL Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation the influence of Adalimumab(ADA) serum concentration, antibody against adalimumab(AAA) and other factors to the ADA efficacy and safety in Ulcerative colitis(UC).
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate and mucosal healing rate at week 8 and 52, based on status of ADA serum concentration and AAA
Key secondary outcomes
CAI and Mayo score at each evaluation time, based on status of ADA serum concentration and AAA.
ADA serum concentration and AAA at each evaluation time based on status of IFX experience and concomitant use of immunomodulators.
The predictors of remission rate and mucosal healing rate at week 8 and 52.
Adverse event based on status of AAA.
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with moderate to severe UC despite concurrent treatment (Mayo score more than 3 points or Mayo sub-score more than 2 points CAI more than 5 points).
Key exclusion criteria
(1) Patients < 15 years of age
(2) Pregnant or likely to be pregnant women
(3) Patients with malignancy
(4) Patients with severe infection
(5) Patients who treated or dose escalated with steroid within 2 weeks.
(6) Patients who treated with IFX within 8 weeks
(7) Patients who treated or dose escalated with Azathioprine and 6-mercaptopurine within 8 weeks.
(8) Patients who treated or dose escalated with tacrolimus within 4 weeks
(9) Patients who treated with ciclosporin within 2 weeks
(10) Patients who treated with cyteapheresis within 2 weeks
(11) Patients not approving the study consent
(12) Patients judged as inadequate at the discretion of physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Imaeda |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Seta Tsukinowa, Otsu, Shiga
TEL
077-548-2217
imaeda@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Imaeda |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
Address
Seta Tsukinowa, Otsu, Shiga
TEL
077-548-2217
Homepage URL
imaeda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Medicine, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine, Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
滋賀医科大学医学部附属病院（滋賀県）、福岡大学筑紫病院（福岡県）、久留米大学医学部附属病院（福岡県）、札幌厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015745
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/01/12 | REAL実施計画書20131227.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
