CORRONA Data Collection Program

IRB Number: 23017

inactive

June 30, 2006

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

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Principal Investigator

Allan Gibofsky, MD, JD, MACR, FACP, FCLM

Co-Investigators

Stephen A. Paget, MD, FACP, FACR
Joseph A. Markenson, MD
Rachel Glaser, MD
Deborah Miller, Research Assistant
Claudia Reuben, Research Assistant
Daniel Horn, Research Assistant
Janine Fernandez, Office Manager

Summary

The Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) Data Collection Program is designed to systematically collect and document use, patterns, effectiveness, and safety of medications such as: Disease Modifying Anti-Rheumatic Drugs (DMARD’s), Nonsteroidal Anti-Inflammatory Drugs (NSAID), biologics, and any other treatments currently used in the management of Rheumatoid Arthritis (RA), Osteoarthritis (OA), Psoriatic Arthritis (PsA), Osteoporosis (OP), and Osteoporosis Risk (OP Risk). It is anticipated that the study data may help improve the quality of information upon which clinical decisions are based.

CORRONA launched the Data Collection Program in an effort to create an information-gathering network for patients with rheumatic diseases in North America. This is not a treatment study; it is an observational study.
Approximately 100,000 patients from as many as 90 sites across the United States are expected to participate.

Patients currently enrolled: 263
Enrollment period: Ongoing, no determined end at this time
Duration of follow-up: Never ending; RA patients receive a follow-up questionnaire no more than once every three months, and PsA patients no more than once very 6 months.

Inclusion/Exclusion Criteria

Inclusion:

Must have documented diagnosis of Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Osteoarthritis, Psoriatic Arthritis, Osteoporosis, or Osteoporosis Risk.
Must be at least 18 years of age
Must see a physician at the Hospital for Special Surgery

Exclusion:

Patients excluded from the study include those excluded based on diagnosis (or age) alone.

Contact Information

Janine Fernandez
212-774-2189
ferrnandezj@hss.edu

Deborah Miller
212-606-1867
millerd@hss.edu