The Corrona RA Data Collection Program (CORRONA)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Corrona RA Data Collection Program|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2002|
|Estimated Primary Completion Date:||December 2100 (Final data collection date for primary outcome measure)|
Pts presenting to enrolling sites across the US are invited to enroll if eligible.
The Corrona Data Collection Program represents a novel advance by collecting, analyzing, and reporting real-time data trends on these issues. Information gathered through the Corrona Data Collection Program is maintained in a comprehensive database (the Corrona Database). The Corrona Organization provides participating sites with access to technology that enables them to interact with and manipulate data maintained in the Corrona Database on their own patient populations. The Corrona Organization uses the Corrona Database for purposes related to clinical, marketing, and outcomes research. Significantly, the Corrona Organization intends to conduct its own novel clinical trials in rheumatology. In addition, the Corrona Organization provides reports regarding information contained in the Corrona Database for a fee to select industry subscribers who are not allowed direct access to the Corrona Database. Rather, they are permitted to submit research queries to the Corrona Organization which are executed by the Corrona biostatisticians who generate appropriate responses to queries.
Physicians and subjects complete Corrona Data Collection Program Questionnaires (see Appendix B) approximately every four months (RA) or six months (PsA and UA). During the course of a regularly-scheduled office visit, the physician performs assessments as mandated on the Corrona Data Collection Program Physician Questionnaires with recording of pertinent data. Results from certain laboratory tests are included, but not mandated, on these Questionnaires. Subjects are asked to complete Data Collection Program Questionnaires designed to capture information ranging from their general demographics and experience with prescription drug use to an overall global assessment of their disease. During their regularly-scheduled physician office visits, it is anticipated that they will spend approximately five to ten minutes completing the Questionnaires. Neither the Questionnaires completed by physicians nor the Questionnaires completed by subjects contain subject's names, addresses, telephone numbers, email addresses, or social security numbers.
Patients are enrolled in the Corrona Data Collection Program during regularly-scheduled office visits. Upon enrollment, physicians complete a set of Enrollment Questionnaires, including a 28 joint count (see Appendix C) and the New Biologic Start (NBS) Questionnaire when appropriate. Subjects also complete a Corrona Data Collection Program Enrollment Questionnaire along with Health Assessment and EQ5D
In the event of a biologic new start or biologic switch in a RA patient, the physician will complete the NBS Questionnaire, Appendix A. Appendix B is to be completed by the physician and subject cooperatively at the very next Corrona visit. If the Appendix B of this Questionnaire is completed at a visit other than the next subsequent visit, the set of Appendices will be null and void. In the event a subject initiates A NEW BIOLOGIC and discontinues a biologic at the same visit, then both Appendices A (FOR THE NEW BIOLOGIC) and B (FOR THE BIOLOGIC BEING DISCONTINUED) will be completed at the same visit.
Data are collected on subjects for as long as they consent to remain in the study.
Any adverse events that are spontaneously volunteered by the subject or discovered as a result of general questioning by the investigator should be recorded on the Provider Follow-up Questionnaire for that visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402661
|United States, New York|
|Center for Rheumatology|
|Albany, New York, United States, 12206|
|Study Director:||Joel Kremer, MD||Center for Rheumatology|