UMIN-CTR Clinical Trial

Public title

Clinical outcomes of Japanese rheumatoid arthritis patients in real world commencing targeted therapy (CORRECT)

Acronym

CORRECT study

Scientific Title

Clinical outcomes of Japanese rheumatoid arthritis patients in real world commencing targeted therapy (CORRECT)

Scientific Title:Acronym

CORRECT study

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate short- and middle-term safety and efficacy of molecular targeting therapies in Japanese patients with RA

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1.Safety outcomes : Incidence rate and type of serious adverse events
2.Efficacy outcomes : Clinical response over time by EULAR response criteria

Key secondary outcomes

1.Safety outcomes : Mortality, Risk factor for serious adverse event
2.Efficacy outcomes : Achievement rates of remission or low disease activity status, achievement of functional remission, drug retention rates.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

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 2010 ACR/EULAR classification criteria for RA.
2. Patients (age >= 20) should have ability and willingness to provide written informed consent and to comply with the requirement of the protocol.
3. Have started treatment with molecular targeting drugs or MTX. A patient who started treatment with these drugs within 30 days is also allowed.

Key exclusion criteria

A patient who has any of the following will be excluded from our study.
1. When a patient withdraw consent to this study
2. When a patient is participating in a clinical trial for approval of drugs at the enrollment.
3. When a patient is regarded as inappropriate to join the study based on medical reasons or other rational reasons by attending physicians' discretion.

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Masayoshi Harigai

Organization

Tokyo Medical and Dental University

Division name

Department of Pharmacovigilance, Department of Medicine and Rheumatology

Zip code

Address

5-45,Yushima 1-chome, Bunkyo-ku, Tokyo

TEL

03-5803-4677

Email

mharigai.mpha@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Marie Yajima

Organization

Tokyo Medical and Dental University

Division name

Department of Pharmacovigilance

Zip code

Address

5-45,Yushima 1-chome, Bunkyo-ku, Tokyo

TEL

03-5803-4677

Homepage URL

Email

yajima.phv@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Department of Pharmacovigilance

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学・北海道大学・埼玉医科大学総合医療センター・長崎大学・横浜市立大学・筑波大学・産業医科大学・東京大学・順天堂大学・京都大学・神戸大学・青梅市立総合病院・東京都健康長寿医療センター・和香会倉敷広済病院・横浜市立みなと赤十字病院・香川大学・東京医科大学・慶應義塾大学・国家公務員東京共済病院、聖路加国際病院
Tokyo medical and dental university, Hokkaido university, Saitama medical center.Nagasaki University, Yokohama city university, Tsukuba university, University of occupational and environmental health, Tokyo metropolitan geriatric hospital, Tokyo university, Juntendo university, Kyoto University, Kobe university, Ome municipal general hospital, Tokyo metropolitan geriatric hospital, Juntendo university, Kagawa university, Ome municipal general hospital, Tokyo kyosai Hospital, Yokohama city minato red cross hospital, Yokohama city minato red cross hospital, Kagawa university, Tokyo medical university, Keio university, Tokyo kyosai Hospital, St Luke's International Hospital

Date of disclosure of the study information

2012

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2012

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Multi-institutional and prospective observational study for safety and efficacy of molecular targeting therapy in Japanese patients with RA

Registered date

2012

Year

01

Month

23

Day

Last modified on

2014

Year

01

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008385