UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011520
Receipt No. R000013474
Scientific Title Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Date of disclosure of the study information 2013/08/19
Last modified on 2013/08/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Acronym Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Scientific Title Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Scientific Title:Acronym Keep persistent efficacy by Abstaining from biological treatment after Numerical SDAI remission with AdalImumab (KANSAI study)
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Medicine in general Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the duration of maintaining low disease activity (LDA) in the rheumatoid arthritis (RA) patients who discontinued adalimumab treatment following achievement of LDA, and make this insight contribute on development of novel treatment option for RA in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of patients with biologic free remission at week 52
Key secondary outcomes 1. Period until bio-free of tapering and stopping arm
2. Proportion of patients with bio-free and the maintain rate
3. Disease activity(DAS,SDAI), mTSS, HAQ at week 26, 52 and 104(after ADA free at week 0, 26, 52 and 104)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After achieve remission and maintain,
ADA is step down and step out over the 104 weeks (arm A)
Interventions/Control_2 After achieve remission and maintain,
Maintenance of previous does with ADA treatment over the 52 weeks, and ADA is step down and step out over the 104 weeks (arm B)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient of RA with Adalimumab treatment that maintain remission (SDAI<=3.3) of twice over the 24 weeks
Key exclusion criteria Patient who using other biologic DMARDs and investigational product.
Patient who treating with LCAP.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Kawahito
Organization Kyoto Prefectural University of Medicine
Division name Inflammation and Immunology
Zip code
Address Kajii-cyo Kawaramachji-Hirokoji Kamigyo-ku Kyoto 602-8566 Japan
TEL 075-251-5505
Email

Public contact
Name of contact person
1st name
Middle name
Last name Aihiro Yamamoto
Organization Kyoto Prefectural University of Medicine
Division name Inflammation and Immunology
Zip code
Address
TEL 075-251-5505
Homepage URL
Email

Sponsor
Institute KANSAI RA investigator
Institute
Department

Funding Source
Organization None
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
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 大阪リハビリテーション病院
大阪南医療センター
近畿大学医学部堺病院
大阪市立大学医学部附属病院
兵庫医科大学
大阪大学医学部附属病院
神戸大学医学部附属病院
天理よろづ相談所病院
京都大学医学部附属病院
医療法人行岡医学研究会 行岡病院
神戸・甲南山手クリニック

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 19 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
2013 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 07 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
2013 Year 08 Month 19 Day
Last modified on
2013 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.