UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Maintenance Trial by Orencia in Rheumatoid Arthritis
Title of the study (Brief title)	MATADOR Study
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the sustainability of administering reduced doses of abatacept to maintain low disease activity in rheumatoid arthritis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Continuance rate of patients receiving a reduced dose of abatacept after 1 year
Key secondary outcomes	1.SDAI,CDAI,DAS28 at 1 year 2.TSS at 1 year 3.HAQ-DI at 1 year 4.Joint Ultrasonography at 1 year

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Aged 20 years or over at given IC 2.Fullfill the 1987ACR classification criteria or ACR/EULAR2010 criteria for RA 3.Patients who received abatacept for more than 24 weeks and have low disease activity 4.Patients who give full consent to this study
Key exclusion criteria	1. Patients contraindicated with abatacept 2. Patients more than 125 kg in weight 3. Patients considered ineligible for this study for any reason by the attending physician
Target sample size	150

Research contact person
Name of lead principal investigator	Tatsuya Atsumi
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine 2
Address	North-15, West-7, Kita-ku, Sapporo, Japan
TEL	011-706-5913
Email	at3tat@med.hokudai.ac.jp

Public contact
Name of contact person	Shinsuke Yasuda
Organization	Hokkaido University Hospital
Division name	Department of Internal Medicine 2
Address	North-15, West-7, Kita-ku, Sapporo, Japan
TEL	011-706-5915
Homepage URL
Email	syasuda@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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)

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	北海道大学病院、青森県立中央病院、沖医院、北海道整形外科記念病院、NTT東日本札幌病院、勤医協中央病院、苫小牧市立病院、いずみ向日葵クリニック、滝川市立病院、東仙台リウマチ科内科クリニック、東北大学病院、北海道内科リウマチ科病院、片山整形外科リウマチクリニック、KKR斗南病院、札幌清田病院

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 11 Day
Anticipated trial start date	2013 Year 03 Month 21 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	2013 Year 03 Month 21 Day
Last modified on	2016 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011990