The CORRONA Data Collection Program

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: April 20, 2012
Last verified: April 2012
  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
Psoriatic Arthritis
Other Rheumatic Conditions

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

Resource links provided by NLM:


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

Enrollment: 33312
Study Start Date: February 2002
Groups/Cohorts
Rheumatology
Pts presenting to enrolling sites across the US are invited to enroll if eligible.

  Show Detailed Description

  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

Patients eligible for the study will be both male and female adult (at least 18 years of age) patients who have a documented diagnosis of RA, PsA, or Undifferentiated Arthritis (UA). Patients excluded from the study include those excluded based on diagnosis (or age) alone. Participating physicians will recruit subjects from their own general patient populations. This study may involve vulnerable subject populations, as many elderly patients with a diagnosis of RA, PsA, or UA will be offered the opportunity to participate in the CORRONA Data Collection Program.

  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: Jeffery Greenberg, MD, MPH NYU College of Medicine
  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: NEIRB 02-021
Study First Received: July 25, 2011
Last Updated: April 20, 2012
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
Arthritis, Psoriatic
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014