CorEvitas Japan Rheumatoid Arthritis (RA) Registry

NCT02737449 | Active Not Recruiting

• 1 other identifier: CorEvitas-RA-102
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. This includes assessing the incidence of adverse events of special interest, in a real-world population of rheumatoid arthritis patients. Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, and current treatment practices.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence rate of adverse events (AEs) will be measured.

  Number of patients who develop malignancy, cardiovascular disease, serious infection, inflammatory bowel syndrome, hepatic events, neurological events and general serious adverse events (SAEs) in Japanese clinical practice will be assessed in subjects receiving Conventional synthetic DMARDs, JAK inhibitors, Anti-TNF biologic DMARDs, and Non-TNF biologic DMARDs as standard of care.

  e outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

Secondary Outcomes (13)

• The number of tender and swollen joints, 28 joint counts, will be recorded as a measure of disease activity.

  1. the outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

• Patient pain assessment will be collected using visual analogue scale measurements (VAS)

  The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

• Physician global disease severity assessment will be collected using VAS

  The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

• Patient global disease severity assessment will be collected using VAS.

  The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

• The duration of morning stiffness will be recorded in minutes or hours. enrollment and subsequent visits

  The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CorEvitas Japan RA Registry has a target enrollment of approximately 2,600 subjects with no defined upper limit on enrollment.This study will recruit patients from approximately 60 clinical sites from a broad geographic distribution in Japan; however, there is no defined upper or lower limit on the number of sites expected to participate.

You may qualify if:

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

You may not qualify if:

• The subject is unable or unwilling to provide informed consent to participate in the registry.

Sponsors & Collaborators

• CorEvitas: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 14, 2016
• Study Start: July 1, 2016
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share