NCT01402661

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 91,758 (estimated)
• Sponsor: CorEvitas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Detailed description

The primary objective for this registry is to systematically collect and document use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents, and any other treatments currently used in the management of RA. The design is a prospective, non-interventional registry for patients with RA under the care of a rheumatologist. Longitudinal data are collected from both patients and their treating rheumatology providers during routine clinical encounters using a structured and standardized data collection method. The scope of data collection includes but is not limited to patient demographics, disease duration, medical history (including all prior and current treatments for RA), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, RA patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2002-02-01
• Primary completion: 2100-12-01
• Completion: 2100-12-01
• First posted: 2011-07-26
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States