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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013788
Receipt No. 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

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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
Email 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
Email imaeda@belle.shiga-med.ac.jp

Sponsor
Institute Department of Medicine, Shiga University of Medical Science
Institute
Department

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
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 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
URL(English) https://upload.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


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