UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015482 |
|---|---|
| Receipt number | R000017994 |
| Scientific Title | Maintenance of remission with 6-week interval of tocilizumab in RA patients who have been in remission |
| Date of disclosure of the study information | 2014/10/21 |
| Last modified on | 2017/11/04 08:40:39 |
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Basic information
Public title
Maintenance of remission with 6-week interval of tocilizumab in RA patients who have been in remission
Acronym
Maintenance of remission by 6-week tocilizumab in RA patients
Scientific Title
Maintenance of remission with 6-week interval of tocilizumab in RA patients who have been in remission
Scientific Title:Acronym
Maintenance of remission by 6-week tocilizumab in RA patients
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of remission maintenance with 6-week interval of tocilizumab for RA patients who have been in remission with monthly tocilizumab therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
remission rate at 1 year after 6-week interval of tocilizumab therapy (DAS28-ESR &/or SDAI)
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
RA Patients who have been treated with tocilizumab for more than 6 months and have been in remisison for more than 3 months
Key exclusion criteria
Patients who have taken more than 5 mg/day of prednisolone
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center,
Saitama Medical University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3859
amanokoi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center, Saitama Medical University Saitama Medical Center, Saitama Medical Univers
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3859
Homepage URL
amanokoi@saitama-med.ac.jp
Sponsor or person
Institute
Department of Rheumatology & Clinical Immunology
Saitama Medical Center, Saitama Medical Universitity
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
| 2014 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
25 cases were enrolled
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
| 2013 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who do not agree to be enrolled to this study and continue monthly tocilizumab will be analyzed as the reference.
Management information
Registered date
| 2014 | Year | 10 | Month | 20 | Day |
Last modified on
| 2017 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
