The Corrona RA Data Collection Program
Status: | Enrolling by invitation |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/16/2018 |
Start Date: | February 2002 |
The Corrona Data Collection Program study is designed 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 Rheumatoid
Arthritis (RA), Undifferentiated Arthritis (UA), Psoriatic Arthritis (PsA), and other
rheumatic diseases. Data collected through the Corrona Data Collection Program will be
maintained in a comprehensive database (the Corrona Database), which will be used for
purposes related to clinical, outcomes, and market research. Participating physicians will
have access to information about their own participating patients, and may use this
information for purposes such as research and in providing patient care. It is anticipated
that the study data may help improve the quality of information upon which clinical decisions
are based.
use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs),
biologic agents and any other treatments currently used in the management of Rheumatoid
Arthritis (RA), Undifferentiated Arthritis (UA), Psoriatic Arthritis (PsA), and other
rheumatic diseases. Data collected through the Corrona Data Collection Program will be
maintained in a comprehensive database (the Corrona Database), which will be used for
purposes related to clinical, outcomes, and market research. Participating physicians will
have access to information about their own participating patients, and may use this
information for purposes such as research and in providing patient care. It is anticipated
that the study data may help improve the quality of information upon which clinical decisions
are based.
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.
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.
Inclusion Criteria:
1. Be at least 18 years of age or older.
2. Be able and willing to provide written consent for participation in the RA Registry,
including the collection of Protected Health Information (PHI). At a minimum, Full
Name and Date of Birth (or Social Security number) are required.
3. Have been diagnosed with rheumatoid arthritis by a rheumatologist according to the
1987 ARA or 2010 ACR/EULAR RA Classification Criteria.
4. Meet one or more of the following criteria:
1. Currently receiving or initiating an FDA-approved biologic (originator or
biosimilar),targeted synthetic DMARD (i.e. JAK inhibitor), and / or conventional
DMARD for the treatment of RA; or
2. Diagnosed within the last 12 months regardless of treatment regimen; or
3. Previously enrolled in Corrona CERTAIN or Treat to Target studies, regardless of
treatment regimen.
Exclusion Criteria:
The patient must not:
1. Have a diagnosis of Juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA),
Spondyloarthritis (SpA), Ankylosing spondylitis (AS), Systemic lupus erythematosus
(SLE), or any other form of autoimmune inflammatory arthritis.
2. Patients participating in or planning to participate in a clinical drug trial (phase
I-III) or a postmarketing study or registry (phase IV) are not eligible for
enrollment.
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