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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017495
Receipt No. 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

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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
Email 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
Email ykaneko@z6.keio.jp

Sponsor
Institute Keio University School of Medicine, Japan.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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