UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034567 |
|---|---|
| Receipt number | R000039401 |
| Scientific Title | Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort- |
| Date of disclosure of the study information | 2018/10/19 |
| Last modified on | 2019/10/21 13:30:40 |
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Basic information
Public title
Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort-
Acronym
Stuy on efficay of bDMARD spacing
Scientific Title
Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort-
Scientific Title:Acronym
Stuy on efficay of bDMARD spacing
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine which bDMARD is most appropriate for spacing in RA patients with persistent stable symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Period of low disease activity by CDAI
Key secondary outcomes
Back ground factor for maintained low disease activity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Rheuamtoid arthritis on EULAR2010 criteria
2. RA activity maintained low disease activity or remission over 3 months treated with golimumab or tocilizumab or abatacept
3. Dose inteval period extended by 1.5 times on golimumab, tocilizumab or abatacept
4. be able to follow up over 60 weeks
Key exclusion criteria
Patients discontinuing therapy for adverse reactions and those withdrawing for reasons unrelated to the drugs
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Matsuno |
Organization
Matsuno Clinic for Rheumatic diseases
Division name
Rheumatology
Zip code
930-0138
Address
7182-2, Kurehacho, Toyama city, Japan, 930-0138
TEL
076-436-1757
info@toyama-ra.com
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Matsuno |
Organization
Matsuno Clinic for Rheumatic diseases
Division name
Rheumatology
Zip code
930-0138
Address
7182-2, Kurehacho, Toyama city, Japan,930-0138
TEL
076-436-1757
Homepage URL
info@toyama-ra.com
Sponsor or person
Institute
Matsuno Clinic for Rheumatic diseases
Institute
Department
Personal name
Funding Source
Organization
Matsuno Clinic for Rheumatic diseases
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
Matsubara Mayflower Hospital ethics committee
Address
944-25, Fujita, Kato, Hyogo
Tel
0795-42-8851
tiken@mayflower-hp.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
松野リウマチ科整形外科、片山整形外科リウマチ科クリニック、松原メイフラワー病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
analysis for continuation rates treated with each biologics with Kaplan-Meier
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2019 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
