An observational study in Rheumatoid Arthritis, sponsored by CorEvitas. Active, not recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by CorEvitas · Observational
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.
The design is a prospective, multicenter, non-interventional, observational study for patients with RA who are newly prescribed eligible medications 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. Longitudinal follow-up data is obtained via CorEvitas Questionnaires completed by both patients and their treating rheumatologists during routine clinical practice. The Enrollment and Follow-Up Questionnaires capture data on patient demographics, targeted medical history including a history of all prior treatments for RA, smoking history, disease duration, disease severity, disease activity, laboratory results, comorbidities, hospitalizations and other targeted safety events.
The study will also monitor a range of clinical effectiveness, patient reported outcomes (PROs), health economic, and safety outcomes, including infections, malignancies and cardiovascular events, among other safety outcomes. Standard components of the European League Against Rheumatism (EULAR) (Disease Activity Score -28 joint count) and American College of Rheumatology (ACR) response criteria, including tender and swollen 28 joint counts, physician and patient global assessment, morning stiffness and pain will be collected at all study visits to enable comparisons of composite disease activity scores (e.g. remission) and response criteria. disease activity score (DAS)-28 erythrocyte sedimentation rates (ESR) will be calculated where possible, as Japanese physicians routinely collect ESR on a more regular basis than U.S. physicians. Composite indices of disease activity, clinical disease activity index (CDAI), DAS, and ACR scores may be calculated from the elements in the CorEvitas Questionnaire for publication. In addition, PROs will be collected via instruments including the EuroQol (EQ)-5D, health assessment questionnaire (HAQ)-DI, and work productivity activity impairment instrument (WPAI) questionnaire.
A primary objective of the registry is analysis of comparative safety. The registry may be linked to other registries for the purposes including comparative safety or outcome studies. The program-specific subject identifier number (ID) will be collected for subjects that participate or have participated in a post-market surveillance study. The ID will be used for to ensure the accuracy of safety reporting to regulators by reducing duplicate reports Note that this study has not been submitted to a United States institutional review board. It has been approved by Japanese Authorities.
2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →CorEvitas is the lead sponsor of 28 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Time frame: 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.
The number of tender and swollen joints, 28 joint counts, will be recorded as a measure of disease activity.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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 severity of morning stiffness, stiffness and associated pain, will be recorded using VAS.
Time frame: 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.
DAS-28 ESR rates will be calculated. .
Time frame: 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.
Composite indices of disease activity: CDAI score, will be calculated from the elements in the CorEvitas Questionnaires.
Time frame: 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.
Composite indices of disease activity, ACR score, will be calculated from the elements in the CorEvitas Questionnaires.
Time frame: 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.
Composite indices of disease activity, DAS score, will be calculated from the elements in the CorEvitas Questionnaires.
Time frame: 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.
PROs will be collected via instruments including the EQ-5D questionnaire.
Time frame: 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.
PROs will be collected via instruments including the HAQ-DI questionnaire.
Time frame: 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.
PROs will be collected via instruments including the WPAI questionnaire.
Time frame: 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.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CorEvitas