UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001222 |
|---|---|
| Receipt number | R000001489 |
| Scientific Title | Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL) |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2014/08/07 13:18:50 |
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Basic information
Public title
Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL)
Acronym
Registry of Japanese Rheumatoid Arthritis patients for Long-term Safety
Scientific Title
Registry of Japanese Rheumatoid Arthritis Patients on Biologics for Long-term Safety (REAL)
Scientific Title:Acronym
Registry of Japanese Rheumatoid Arthritis patients for Long-term Safety
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the long-term safety of biologics with that of conventional DMARDs in Japanese patients with RA.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate of serious adverse events.
Key secondary outcomes
Type of serious adverse events, long term prognosis, death rates.
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
Patients must meet the following criteria to be eligible for study entry:
1. Fulfill the 1987 American College of Rheumatology criteria.
2. Patients (age > 20) should have ability and willingness to provide written informed consent and to comply with the requirement of the protocol.
3. Parents of patients (age < 20) should have ability and willingness to provide written informed consent and to comply with the requirement of the protocol.
4. Have started treatment with biologics or non-biological disease modifying anti-rheumatic drug within last six months and are still receiving these treatments at study entry.
# Until December 2006, patients who had been continuing treatment with non-biological disease modifying anti-rheumatic drugs more than 6 months at study entry were also enrolled.
# Biologics in this study include infliximab, etanercept, tocilizumab and adalimumab as of June 2008, but other drugs will also be included after their approval in Japan.
Key exclusion criteria
A patient who has any of the following will be excluded from the study.
1. When a patient is participating in a clinical trial for approval of drugs (i.e., chiken) at the enrollment.
2. When a patient is regarded as inappropriate to join the study based on medical reasons or other rational reasons.
3. When a patient refuses to join the study or withdraw his or her consent.
4. When it is revealed that a patient did not satisfy the inclusion criteria at the enrollment or satisfies one of the exclusion criteria at the enrollment.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Harigai |
Organization
Tokyo Medical and Dental University
Division name
Department of Pharmacovigilance
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-5803-4677
mharigai.mpha@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Harigai |
Organization
REAL study headquarters
Division name
Tokyo Medical and Dental University, Department of Pharmacovigilance
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-5803-4677
Homepage URL
https://www.real-study.jp/index.html
mharigai.mpha@tmd.ac.jp
Sponsor or person
Institute
Department of Pharmacovigilance, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Pharmacovigilance, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
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
| 2008 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.real-study.jp/doctor/doctor_index.html
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
| 2005 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Association of usage of biologics and serious adverse events will be analysed.
Management information
Registered date
| 2008 | Year | 06 | Month | 30 | Day |
Last modified on
| 2014 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001489
