UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007224 |
|---|---|
| Receipt number | R000008507 |
| Scientific Title | Registry of the patients with rheumatoid arthritis treated with Biologics in routine clinical practice. |
| Date of disclosure of the study information | 2012/02/03 |
| Last modified on | 2017/03/20 17:07:18 |
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Basic information
Public title
Registry of the patients with rheumatoid arthritis treated with Biologics in routine clinical practice.
Acronym
FRAB Registry
Scientific Title
Registry of the patients with rheumatoid arthritis treated with Biologics in routine clinical practice.
Scientific Title:Acronym
FRAB Registry
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of the drug survival, clinical response and remission in patients with RA treated in clinical practice with Biologics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical remission rate
Key secondary outcomes
Continuation rate, time course of DAS-ESR, incidence rate and type of adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Fulfill the 1987 ACR or 2010 ACR/EULAR classification criteria for RA.
2)RA patients who treated in biologics ( Tocilizumab, Infliximab, Etanercept, Adalimumab, Abatacept, and Golimumab) at clinical practice.
3)Patients who obtains agreement for participation in present this study.
Key exclusion criteria
When a patient is regarded as inappropriate to join the study by physicians' discretion
When a patient withdraw consent to this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Kondo |
Organization
Kondo Clinic of Rheumatology and Orthopaedic Surgery
Division name
Kondo Clinic of Rheumatology and Orthopaedic Surgery
Zip code
Address
3-10-11 Tenjin, chuou-ku, Fukuoka,
TEL
092-762-2380
yasunaka@ortho.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuharu Nakashima |
Organization
Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka,
TEL
092-642-5487
Homepage URL
yasunaka@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
FRAB Registry
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
Kondo Clinic of Rheumatology,Kyushu University,Fukuoka University,Kyushu Medical Center, etc
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 | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate of efficacy and safety in patients with RA treated in clinical practice with Biologics.
Management information
Registered date
| 2012 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008507
