UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010286 |
|---|---|
| Receipt number | R000011990 |
| Scientific Title | Maintenance Trial by Orencia in Rheumatoid Arthritis |
| Date of disclosure of the study information | 2013/03/21 |
| Last modified on | 2016/09/27 14:22:45 |
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Basic information
Public title
Maintenance Trial by Orencia in Rheumatoid Arthritis
Acronym
MATADOR Study
Scientific Title
Maintenance Trial by Orencia in Rheumatoid Arthritis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuya Atsumi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine 2
Zip code
Address
North-15, West-7, Kita-ku, Sapporo, Japan
TEL
011-706-5913
at3tat@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Yasuda |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine 2
Zip code
Address
North-15, West-7, Kita-ku, Sapporo, Japan
TEL
011-706-5915
Homepage URL
syasuda@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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)
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
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011990
| 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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