CLINICAL TRIAL EVALUATES NEW ARTHRITIS THERAPY

November 1, 2002

UNT Health Science Center is participating in the worldâ??s largest arthritis clinical trial, which is evaluating a new investigational drug compound. TARGET, or Therapeutic Arthritis Research and Gastrointestinal Event Trial, will evaluate more than 18,000 patients worldwide during a 12-month period.

TARGETâ??s primary objective is to examine the gastrointestinal safety of a new drug compound from Novartis Pharmaceuticals Corporation. It will compare the investigational drug to the non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen. It will also study the cardiovascular safety, tolerability and efficacy of all three drugs.

Novartisâ?? investigational drug is a new class of NSAIDs that selectively block the release of the enzyme cyclooxygenase-2 (COX-2). If left unblocked, the COX-2 enzyme triggers the release of hormone-like compounds, which cause inflammation and produces pain.

â??TARGET is the first COX-2 inhibitor gastrointestinal safety trial where cardiovascular safety will be assessed as one of the pre-specified endpoints,â? said Bernard Rubin, DO, MPH, chief of rheumatology.

In previous clinical trials, researchers found that NSAIDs and COX-2 inhibitors have varying incidence rates of severe adverse reactions, such as heart attacks and gastrointestinal bleeding. What remains unclear is whether or not there is a true difference between the newer and older drugs in overall safety, Dr. Rubin said.By examining the effects of the drug on the gastrointestinal system, researchers hope to find out if patients who use COX-2 inhibitors for their arthritis suffer from fewer peptic ulcers than those who use NSDAIDs for their pain relief. The study will also try to determine whether patients taking COX-2 inhibitors have fewer heart attacks than those taking NSAIDs.

Study participants will receive free study-related care during the year-long trial, including periodic physician office visits, study medication, lab tests and electrocardiograms. Participants must be 50 or older and experiencing symptoms of osteoarthritis for three months or longer.

TARGET will not be the largest arthritis clinical trial for long. Merck is preparing to launch an arthritis clinical trial of another new COX-2 inhibitor drug in a clinical trial of its own, enrolling approximately 25,000 patients worldwide. The health science center will be one of the sites for that trial as well.

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