UMIN-CTR Clinical Trial

Public title

Corrona Japan Rheumatoid Arthritis (RA) Registry

Acronym

Corrona Japan Rheumatoid Arthritis (RA) Registry

Scientific Title

Corrona Japan Rheumatoid Arthritis (RA) Registry

Scientific Title:Acronym

Corrona Japan Rheumatoid Arthritis (RA) Registry

Region

Japan

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective is to prospectively study the comparative effectiveness and comparative safety of approved therapies for RA in a Japanese cohort of patients treated by rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of DMARDs (e.g. higher dose MTX, non-TNF biologics, and JAK inhibitors) will be compared with anti-TNF biologics.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary objective is to prospectively study the comparative effectiveness and comparative safety of approved therapies for RA in a Japanese cohort of patients treated by rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of DMARDs (e.g. higher dose MTX, non-TNF biologics, and JAK inhibitors) will be compared with anti-TNF biologics.

Key secondary outcomes

Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, and current treatment practices.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) The subject must be diagnosed with rheumatoid arthritis according to the 1987 ACR or the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria
2) The subject must be at least 18 years of age or older
3) The subject must be able and willing to provide written consent
4) The subject must be prescribed or switching to an eligible medication or the first time ever at the Enrollment Visit. History of or concomitant treatment with other eligible medications does not exclude a subject from enrollment.

Key exclusion criteria

NA

Target sample size

2600

Name of lead principal investigator

1st name	Hisashi
Middle name
Last name	Yamanaka

Organization

Tokyo Women's Medical University

Division name

Institute of Rheumatology Tokyo Women's Medical University

Zip code

162-0054

Address

10-22 Kawada-Cho, Shinjuku-Ku, Tokyo

TEL

03-5269-1711

Email

yamanaka@twmu.ac.jp

Name of contact person

1st name	Yoshihito
Middle name
Last name	Sawai

Organization

Fortrea Japan K.K.

Division name

Clinical Development Services

Zip code

104-6108

Address

Harumi Triton Square Office Tower Y8F, 1-8-11, Harumi, Chuo-ku, Tokyo

TEL

03-6837-9500

Homepage URL

Email

Yukiko.Hagihara@labcorp.com

Institute

CorEvitas, LLC

Institute

Department

Personal name

Organization

CorEvitas, LLC

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

United States of America

Co-sponsor

Name of secondary funder(s)

Organization

NA

Address

NA

Tel

NA

Email

NA

Secondary IDs

YES

Study ID_1

NCT02737449

Org. issuing International ID_1

Clinical Trials

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

08

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

Open public recruiting

Date of protocol fixation

2015

Year

10

Month

21

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design:Prospective, multicenter, non-interventional, observational study for patients with rheumatoid arthritis who are newly prescribed methotrexate, a biologic DMARD, or a JAK inhibitor at the time of enrollment into the registry. The drug is prescribed per the physician's decision which precedes the decision to enroll the patient into the registry.
Registry duration:The Corrona Japan RA Registry is a longitudinal, observational study; therefore, the duration of follow-up is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately two (2) years.
Subject recruitment:Participating investigators recruit subjects with RA from their own patient populations as defined by the Subject Eligibility criteria .

Registered date

2016

Year

03

Month

08

Day

Last modified on

2023

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024117