UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008578 |
|---|---|
| Receipt number | R000010077 |
| Scientific Title | Efficacy and safety of abatacept in RA patients in daily clinical practice: An retrospective observational study Orencia as Biological Intensive Treatment for RA |
| Date of disclosure of the study information | 2012/08/05 |
| Last modified on | 2012/07/31 13:27:29 |
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Basic information
Public title
Efficacy and safety of abatacept in RA patients in daily clinical practice: An retrospective observational study
Orencia as Biological Intensive Treatment for RA
Acronym
ORBIT study
Scientific Title
Efficacy and safety of abatacept in RA patients in daily clinical practice: An retrospective observational study
Orencia as Biological Intensive Treatment for RA
Scientific Title:Acronym
ORBIT 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 clinical, functional, and radiographic response to ABA in Japanese RA patients encountered in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with structural remission (modified total Sharp score(mTSS) ≤0) at week 24,52,104.
Key secondary outcomes
Proporon (Simplified Disease Activity Index:SDAI≤3.3) or with functional remission (Health Assessment Questionaire:HAQ ≤0.5) at week 24, 52,104
Disease Activity Score:DAS28 CRP/SDAItion of patients with clinical remissi
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who give a full consent to this study
2.Rheumatoid arthritis patinets according to criteria of ACR1987 or ACR/EULAR2010
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 | 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
Keio University School of Medicine
Institute of Rheumatology Tokyo Women's Medical University
Saitama Medical Center, Saitama Medical University
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 | 05 | 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
| 2012 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective
Management information
Registered date
| 2012 | Year | 07 | Month | 31 | Day |
Last modified on
| 2012 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010077
