UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004651 |
|---|---|
| Receipt number | R000005542 |
| Scientific Title | Abatacept Research Outcome as a First-line Biological Agent in the Real World |
| Date of disclosure of the study information | 2010/12/06 |
| Last modified on | 2015/06/01 19:45:02 |
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Basic information
Public title
Abatacept Research Outcome as a First-line Biological Agent in the Real World
Acronym
ABROAD study
Scientific Title
Abatacept Research Outcome as a First-line Biological Agent in the Real World
Scientific Title:Acronym
ABROAD study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the remission rate, safety and persistence rate in RA patients after 48weeks of treatment of abatacept in the real world.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of subjects in remission(2010 ACR/EULAR new RA remission criteria. DAS28-CRP<2.3)
(48 Weeks)
Key secondary outcomes
Persistence rate
Stratified analysis of remission rate
(in each disease duration)
Change in HAQ
Change in Anti-CCP2
X-ray
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Meet the criteria for Post Marketing Surveillance in Japan.
2) Biologic Naive.
3) Stable low dose of corticosteroids
(<=10mg per day)at least 28 days before enrollment.
Key exclusion criteria
Patients who are inadequate by investigator's decision.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Sano |
Organization
Department of Internal Medicine, Hyogo College of Medicine
Division name
Division of Rheumatology
Zip code
Address
1-1 Mukogawa-Cho Nishinomiya Hyogo
TEL
0798-45-6591
hsano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Sano |
Organization
Department of Internal Medicine, Hyogo College of Medicine
Division name
Division of Rheumatology
Zip code
Address
1-1 Mukogawa-Cho Nishinomiya Hyogo
TEL
0798-45-6592
Homepage URL
hsano@hyo-med.ac.jp
Sponsor or person
Institute
Division of Rheumatology Department of Internal Medicine, Hyogo College of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
DAS28-CRP, Patient's ovreall assessment, Physicians's overall assessment, MMP-3, X-ray, Anti-CCP2, safety profiles
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005542
