CorEvitas Japan Rheumatoid Arthritis (RA) Registry

CorEvitas

Status: Invitation-only

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02737449

CorEvitas-RA-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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