UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab
Title of the study (Brief title)	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	Tsutomu Takeuchi
Organization	Keio University School of Medicine, Japan.
Division name	Division of Rheumatology, Department of Internal Medicine,
Address	35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL	03-3353-1211
Email	tsutake@keio.jp

Public contact
Name of contact person	Yuko Kaneko
Organization	Keio University School of Medicine, Japan.
Division name	Division of Rheumatology, Department of Internal Medicine,
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020277