Precision Trial

A Randomized, Double-Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patient With or at High Risk for Cardiovascular Disease Comparing Celecoxib with Naproxen and Ibuprofen.

Study Phase IV

Purpose

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDS) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk o developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

The study population will include those who meet the following inclusion/exclusion criteria, some of which are:

Inclusion criteria

1. Demographics: > 18 years of age.
   
2. Signed & dated, written informed consent to participate in this study.
   
3. Subjects with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis signs and symptoms.
   

Exclusion criteria

1. Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization.
   
2. Subjects with medical or laboratory abnormality that would make this the subject inappropriate for entry into this trial
   
3. Subjects require treatment with aspirin > 325 mg/day
   
4. Subjects with known hypersensitivity celecoxib, ibuprofen, naproxen, aspirin or esomeproazole, etc.

To inquire if you are eligible for this study to hear more about it, please contact:

Lori Brazee
Clinical Research Coordinator
Office#: 781-505-8710
Email: lbrazee@pchi.partners.org