UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017495 |
|---|---|
| Receipt number | R000020277 |
| Scientific Title | Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab |
| Date of disclosure of the study information | 2015/11/26 |
| Last modified on | 2016/11/10 09:26:08 |
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Basic information
Public title
Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab
Acronym
Methotraxate and Adalimumab study, to Space and TapEr for Rheumatoid arthritis patients at maintenance period (MASTER study)
Scientific Title
Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab
Scientific Title:Acronym
Methotraxate and Adalimumab study, to Space and TapEr for Rheumatoid arthritis patients at maintenance period (MASTER study)
Region
| Japan |
Condition
Condition
rheumatoid arthritis(RA)
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the suitable strategy of the maintenance therapy for RA patient with methotrexate(MTX) and adalimumab(ADA), through investigating the possibility of reducing the dose of the drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MTX reducing group: last MTX dose
ADA spacing group: last intervals of ADA
Key secondary outcomes
at 48 weeks) the rate of maintain of DAS28<2.6
the possibility of MTX reducing and stopping
the possibility of ADA spacing and stopping
the concentration of MTX-PG
the transition of disease activity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dose maintain group: no change of treatment
Interventions/Control_2
MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped.
Interventions/Control_3
ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped.
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) the RA patients comfortable for the 1987 ACR RA classification criteria or 2010 ACR/EULAR RA classification criteria.
2) the patients who are maintaining RA crinical remission(DAS28<2.6) with MTX and 40mg/2weeks of ADA during 6 month.
3) the patients who agree this study after sufficient informed consent.
Key exclusion criteria
1) the patient who are assessed unsuitable.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Keio University School of Medicine, Japan.
Division name
Division of Rheumatology, Department of Internal Medicine,
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-3353-1211
tsutake@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kaneko |
Organization
Keio University School of Medicine, Japan.
Division name
Division of Rheumatology, Department of Internal Medicine,
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-3353-1211
Homepage URL
ykaneko@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Japan.
Institute
Department
Personal name
Funding Source
Organization
Division of Rheumatology, Department of Internal 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
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 | 11 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
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 | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020277
