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

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 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


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

Value
https://center6.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