UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008756 |
|---|---|
| Receipt number | R000010285 |
| Scientific Title | Abatacept-based approach to cure of RA |
| Date of disclosure of the study information | 2012/08/30 |
| Last modified on | 2012/08/23 15:27:39 |
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Basic information
Public title
Abatacept-based approach to cure of RA
Acronym
ACURE study
Scientific Title
Abatacept-based approach to cure of RA
Scientific Title:Acronym
ACURE study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of biologic free of abatacept
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with remission at month 24
Key secondary outcomes
1, RF, anti CCP antibody at month 24
2, delta TSS at month 24
3. HAQ at month 24
4, DAS 28 at month 30
5, RF, anti CCP antibody at month 30
6, delta TSS at month 30
7, HAQ at month 30
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Abatacept treatmentat month 12
Interventions/Control_2
MTX treatment at month 12
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
| 15 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.RA patients
2.Treated with MTX more than 6mg/week and biologic agents other than abatacept, DAS28-ESR less than 3.2
3.Patients with drug free wish
4.Consent about non-randomization
5.Patients who give a full consent to this study
Key exclusion criteria
1,Contraindication with abatacept
2, Patients treated with abatacept
3, Using PSL, plasma pheresis, joint replacement and other surgical treatment
4 Chronic active EBV infection
5,Chronic HBV infection
6, Infection
7, Patients who are pregnant, who are nursing or who hope to be pregnant
8, Patients who are inadequate by investigator's decision.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
0936031611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
0936031611
Homepage URL
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2012 | Year | 08 | Month | 30 | 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
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
| 2012 | Year | 08 | Month | 23 | Day |
Last modified on
| 2012 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010285
| 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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| Registered date | File name |
