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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001222
Receipt No. 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

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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
Email 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
Email mharigai.mpha@tmd.ac.jp

Sponsor
Institute Department of Pharmacovigilance, Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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