This is a clinical trial comparing the effects of celecoxib, ibuprofen, and naproxen on people with rheumatoid arthritis (RA) and/or osteoarthritis (OA) who also have, or are at risk for, cardiovascular problems. All of these medications have been approved by the FDA and are commonly used to treat arthritis pain. The trial is sponsored by the Cleveland Clinic and Pfizer, Inc.

There have been questions raised recently as to the safety of both cox-2 inhibitors (celecoxib) and other NSAIDs (non-steroidal anti-inflammatory drugs) like naproxen and ibuprofen, in people who have or are at high risk for heart disease. This study will help answer these questions and assist doctors in learning more about the long term safety of these medications on the heart.

First you will come for a screening visit where it will be determined if you are eligible to participate in the study. You will be examined by the study doctor who will ask you about your health, medications, and arthritis symptoms. Your blood pressure and pulse will be checked and you will have a blood test.

If you qualify and want to continue, you will come for a second visit where you will have an ECG (heart test), answer some questionnaires, and have some blood tests done. You will be given one of the three drugs listed above to take regularly at home. Which one you receive will be determined at random, like the flip of a coin. Neither you nor the study staff will know which one you have been given.

You will return for study visits every 4 to 12 weeks for the first year, after which visits will be every 6 months. You will be asked about any problems or illnesses you have had between visits and be given a new supply of the same drug you were assigned originally. Blood tests will be performed and you will complete questionnaires about your health. You will be asked to call the study staff in between visits if you have any serious problems.

The study will last for as long as five years, or until each subject enrolled has completed at least 18 months on study drugs. The study may be stopped for other reasons which will be explained to you by study staff if you decide to participate.

You will receive monetary compensation for your time during the study.

Approximately 34 study visits are required during the screening, treatment, and follow-up periods of this study over the course of about 1 year. The visits will last approximately 2 hours for the screening visit, 6-8 hours on the days you receive the study drug and 1-2 hours for all other visits.

Since the use of NSAIDs is very widespread for reducing the symptoms of RA and OA, this study is extremely important to help doctors decide if these drugs are safe for their patients to take on a regular basis. You can help us answer this question.

The results of your exam, blood tests and ECG will be available to you and can be shared with your regular doctor if you wish.

You may experience some relief from your arthritis symptoms, but this cannot be guaranteed. You will receive all the study medicines at no cost to you.

Principal Investigator: Dr. Mary Anne Dooley
Lupus Clinical Trials Coordinator: Brenda Meier, RN (919-843-6619)