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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022596
Receipt No. R000026026
Scientific Title Discontinuation of biological agents without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis
Date of disclosure of the study information 2016/10/01
Last modified on 2016/06/03

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Basic information
Public title Discontinuation of biological agents without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis
Acronym KINKI STUDY
Scientific Title Discontinuation of biological agents without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis
Scientific Title:Acronym KINKI STUDY
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the disease activity, functional disability and radiographic damage progression after discontinuation of biological agents in RA patients who achieved and maintained remission
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes At 6 monhs after discontinuation of biological agents, the estimation in DAS28, CDAI, and SDAI with the RA patients who achieved the remission.
Key secondary outcomes 1) Radiograghic X ray (modified Sharp score)
2) Ultrasonography (synovitis; Gray Scale and Power Doppler)
3) Health assessment questionare score (HAQ)
4) Patients character (Age, Sex, Disease duration, Stage, Class)
5) Biomarker (CRP, ESR, RF, anti-CCP Ab)

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 Use of Biological agents
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed by the criteria of 2010 ACR/EULAR with RA
2) The patients who sustained the remission (DAS28 < 2.6) at least 6 months
Key exclusion criteria 1) The patients who refused to join this study.2) The patients who prescribed up-dose in DMARDS, steroids, and NSAIDs and done the joint injection 3) severe infection 4) demyelinating disease (multiple sclerosis), 5) congestive heart failure, 6) Patient who is lactating, pregnant, possibly pregnant or do not agree with the study.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Nozaki
Organization Kinki University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 0723-66-0221
Email yuji0516@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nozaki
Organization Kinki University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code
Address 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan
TEL 0723-66-0221
Homepage URL
Email yuji0516@med.kindai.ac.jp

Sponsor
Institute Department of Hematology and Rheumatology, Kinki University School of Medicine
Institute
Department

Funding Source
Organization Department of Hematology and Rheumatology, Kinki University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 06 Month 03 Day
Last modified on
2016 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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