UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012690 |
|---|---|
| Receipt number | R000014824 |
| Scientific Title | Study of Actemura Remission induction of RA and Sequential Maintenance of Remission by Reasonable cost Treatment |
| Date of disclosure of the study information | 2013/12/27 |
| Last modified on | 2016/12/27 09:35:26 |
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Basic information
Public title
Study of Actemura Remission induction of RA
and Sequential Maintenance of Remission by Reasonable cost Treatment
Acronym
STARR-SMARRT
Scientific Title
Study of Actemura Remission induction of RA
and Sequential Maintenance of Remission by Reasonable cost Treatment
Scientific Title:Acronym
STARR-SMARRT
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Biologics treatment is targeted at a required rheumatoid arthritis patient.
Tocilizumab is prescribed for the patient for one year, and a medical treatment aim (clinical remission and when difficult, it is a low disease activity) is achieved (remission induction therapy).
Then, it changes to a tacrolimus + bucillamine combined therapy, and maintains a medical treatment target (remission maintenance therapy).
After achieving a medical treatment aim, using biological preparation positively, the possibility of long-term maintenance is examined using comparatively cheap DMARDs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The low disease activity (DAS28ESR<3.2) maintenance rate after 24 weeks of TCZ treatment
Key secondary outcomes
The clinical remission (DAS28ESR<2.6) and the low disease activity (DAS28ESR<3.2) maintenance rate after 52 weeks of the clinical remission (DAS28ESR<2.6) maintenance rate
- DAS28ESR transition
- MMP-3 transition
- HAQ-DI transition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tocilizumab+tacrolimus+Bucillamine
Interventions/Control_2
tocilizumab
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.RA patients diagnosed by ACR/EULAR criteria(2010)
2.RA patients whose DAS28ESR is over 3.2
3.RA patients who have inadequate response to DMARDs
4.RA patients who is willing to participate in this study and signed the informed consent
Key exclusion criteria
1.Patients with severe infection
2.Patients with active tuberclosis
3.Patients with malignancy
4.pregnant or breast-feeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryutaro Matsumura |
Organization
National hospital organization Chiba east national hospital
Division name
Clinical Research Center
Zip code
Address
673 Nitonacho Tyuuouku Chiba city Chiba
TEL
043-261-5171
ryu-ma@ka2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryutaro Matsumura |
Organization
National hospital organization Chiba east national hospital
Division name
Clinical Research Center
Zip code
Address
673 Nitonacho Tyuuouku Chiba city Chiba
TEL
043-261-5171
Homepage URL
ryu-ma@ka2.so-net.ne.jp
Sponsor or person
Institute
National hospital organization Chiba east national hospital Clinical Research Center
Institute
Department
Personal name
Funding Source
Organization
National hospital organization Chiba east national hospital Clinical Research Center
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
国立病院機構千葉東病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 27 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2016 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014824
| 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 |
