CorEvitas, LLC
Waltham, Massachusetts, 02451, United States
NCT Number: NCT01402661
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Waltham, Massachusetts, 02451, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(A) Currently receiving an Eligible Medication** that was started within 365 days of the Enrollment Visit.
i. A temporary interruption of an Eligible Medication is allowed if the interruption in treatment lasted <180 days.
(B) Prescribed or receiving the first dose of an Eligible Medication** on the day of the Enrollment Visit.
(C) Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen ("Early RA").
Exclusion criteria
The patient must not:
Early Follow-Up Visit Criteria
To be eligible for an early CorEvitas Follow-Up Visit that is conducted <150 days since the last registry visit, the following conditions must be met:
Time frame: Data are collected on subjects for as long as they consent to remain in the study
CorEvitas
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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