UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022596 |
|---|---|
| Receipt number | 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 | 2023/12/09 12:09:49 |
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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 | Yuji |
| Middle name | |
| Last name | Nozaki |
Organization
Kinki University School of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
589-8511
Address
Osaka-Sayama
TEL
0723660221
yuji0516@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nozaki |
Organization
Department of Hematology and Rheumatology, Kinki University School of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
589-8511
Address
Osaka-Sayama
TEL
0723660221
Homepage URL
yuji0516@med.kindai.ac.jp
Sponsor or person
Institute
Department of Hematology and Rheumatology, Kinki University School of Medicine
Institute
Department
Personal name
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
Department of Hematology and Rheumatology, Kinki University School of Medicine
Address
Osaka-Sayama
Tel
0723660221
yuji0516@med.kindai.ac.jp
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | Day |
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
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026026
