Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry
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|ClinicalTrials.gov Identifier: NCT01402661|
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2011
Last Update Posted : February 12, 2020
|Condition or disease|
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 Corrona related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
|Study Type :||Observational|
|Actual Enrollment :||33312 participants|
|Official Title:||Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry|
|Study Start Date :||February 2002|
|Estimated Primary Completion Date :||December 2100|
Pts presenting to enrolling sites across the US are invited to enroll if eligible.
- Patterns, effectiveness, and safety of DMARDs, biologic agents and any other treatments currently used in the management of RA [ Time Frame: Data are collected on subjects for as long as they consent to remain in the study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402661
|United States, New York|
|Center for Rheumatology|
|Albany, New York, United States, 12206|
|Study Director:||Joel Kremer, MD||Center for Rheumatology|