The Corrona RA Data Collection Program (CORRONA)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Massachusetts, Worcester
University of Alabama at Birmingham
Brigham and Women's Hospital
Information provided by (Responsible Party):
The Consortium of Rheumatology Researchers of North America, Inc.
ClinicalTrials.gov Identifier:
NCT01402661
First received: July 25, 2011
Last updated: June 8, 2015
Last verified: June 2015
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Corrona RA Data Collection Program

Resource links provided by NLM:


Further study details as provided by The Consortium of Rheumatology Researchers of North America, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 33312
Study Start Date: February 2002
Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis
Pts presenting to enrolling sites across the US are invited to enroll if eligible.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are enrolled in the CORRONA Data Collection Program during regularly-scheduled office visits. Selected rheumatologists are invited to participate as investigators in the CORRONA Data Collection Program. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout the country with rheumatic diseases. All potential sites are screened for clinical research experience and adherence to GCP (Good Clinical Practice) guidelines

Criteria

Inclusion Criteria:

  • Male or female patients, at least 18 years of age
  • Able and willing to provide written consent for participation
  • Meeting one of the following diagnostic criteria for RA:
  • Diagnosis of RA by 1987 ARA or 2010 ACR/EULAR criteria and on an approved biologic or small molecule medication
  • Diagnosed with RA within the last 12 months and meet 1987 ARA or 2010 ACR/EULAR RA diagnostic criteria regardless of RA treatment regimen
  • Subjects previously enrolled in Corrona Treat to Target trial, regardless of treatment regimen at the time of enrollment into the RA registry

Exclusion Criteria:

- The subject is unable or unwilling to provide informed consent to participate in the registry

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402661

Locations
United States, New York
Center for Rheumatology
Albany, New York, United States, 12206
Sponsors and Collaborators
The Consortium of Rheumatology Researchers of North America, Inc.
University of Massachusetts, Worcester
University of Alabama at Birmingham
Brigham and Women's Hospital
Investigators
Study Director: Joel Kremer, MD Center for Rheumatology
  More Information

Additional Information:
No publications provided

Responsible Party: The Consortium of Rheumatology Researchers of North America, Inc.
ClinicalTrials.gov Identifier: NCT01402661     History of Changes
Other Study ID Numbers: Corrona-RA-100
Study First Received: July 25, 2011
Last Updated: June 8, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The Consortium of Rheumatology Researchers of North America, Inc.:
rheumatoid arthritis
psoriatic arthritis
disease registry

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 30, 2015