UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017577 |
|---|---|
| Receipt number | R000020368 |
| Scientific Title | Tapering and withdrawal of Methotrexate(MTX) or Tocilizumab(TCZ), after achievement of RA remission in concomitant use of MTX and TCZ,a randomized control study. |
| Date of disclosure of the study information | 2015/05/31 |
| Last modified on | 2019/04/06 00:48:00 |
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Basic information
Public title
Tapering and withdrawal of Methotrexate(MTX) or Tocilizumab(TCZ), after achievement of RA remission in concomitant use of MTX and TCZ,a randomized control study.
Acronym
Spacing tocilizumab vs tapering methotrexate study in Keio university, for rheumatoid arthritis patients In remission Phase.[SKIP] study
Scientific Title
Tapering and withdrawal of Methotrexate(MTX) or Tocilizumab(TCZ), after achievement of RA remission in concomitant use of MTX and TCZ,a randomized control study.
Scientific Title:Acronym
Spacing tocilizumab vs tapering methotrexate study in Keio university, for rheumatoid arthritis patients In remission Phase.[SKIP] study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the possibility to taper or to discontinue MTX or TCZ after the achievement of RA remission, in use of both MTX and TCZ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
DAS28-ESR remission rate at 12week after discontinuing MTX or TCZ
Key secondary outcomes
1.discontinuation rate of TCZ
2.discontinuation rate of MTX
3.spacing interval of TCZ before RA flare
4.dose of MTX before RA flare
5.concentration of MTX-PG, extra/intra-cellular molecule at (1)initiation of tapering treatment (2)during tapering (3)after cessation of MTX or TCZ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
continue treatment
Interventions/Control_2
spacing and discontinue TCZ
Interventions/Control_3
tapering and discontinue TCZ
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.RA patients who maintained remission(DAS28-ESR<2.6)for>=24weeks by administration of TCZ(8mg/kg)by interval of 4week and concomitant use of MTX(>=6mg/week)
Key exclusion criteria
1.Patients who do not agree to participate in this study
2.Patient with any reasons for inadequate to participate in this study, judged by attending rheumatologist.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-3353-1211
tsutake@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuntaro Saito |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
03-3353-1211
Homepage URL
shun081359@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
| 2015 | Year | 05 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020368
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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