RESEARCH ON NEW DRUGS

The Arthritis Center of Connecticut’s Division of Rheumatology, Osteoporosis, and Pain Management, has developed a specific team for advanced pharmaceutical research.  Under the direction of Dr. Brian Peck, the medical director of the Center, the group of experienced professionals has been participating in pharmaceutical research projects for years.  Now, with their formal designation as a Central Research Site by several CROs (central research organization), the team has reached the next level of sophistication.
            
Through CROs, organizations responsible for central coordination of facilities throughout the country, the Arthritis Center recruits patients and local medical practices for Phase II, III, and IV pharmaceutical development.  Every new medication brought to market must pass through these phases before the Food and Drug Administration (FDA) will legally approve its use.  The studies are performed to validate claims of safety and effectiveness.  This is the only way to assure safety and adequate oversight by government regulators.

The actual oversight is performed by central review boards, which are approved in advance by the FDA.  The review boards have open access to each study facility’s site and records.  Each patient must be fully informed of potential side-effects in advance.  “Without studies such as these,” said Rick Pope, research coordinator and physician assistant with over 14 years of experience in this area, “valuable new drugs could never be made available to the public.”

All participants are volunteers, and in some cases are paid.  Currently, the Arthritis Center is conducting studies in the areas of new anti-inflammatory medications for osteoarthritis, osteoporosis, chronic pain, anti-viral agents for colds, and advanced disease-modifying agents for rheumatoid arthritis.

The newest category of arthritis drugs is for rheumatoid arthritis.  The new drugs are called TNF inhibitors.  These drugs are the result of recombinant DNA research and the discovery of a class of proteins with specific biologic actions.  The proteins, called cytokines, are manufactured by our body’s cells.  One such cytokine, TNF (tumor necrosis factor) is important for the normal and natural prevention of cancer and infections.  In those with RA (rheumatoid arthritis) and in some other diseases (such as Crohn’s disease, an inflammatory condition of the bowel), TNF is over-active, resulting in inflammation and joint destruction.

The TNF inhibitors are capable of decreasing the activity of TNF, resulting in less inflammation.  Studies have shown that the TNF inhibitors are capable of halting the progression of RA, allowing patients to decrease or stop other medications and increase their level of activity, sometimes to normal.  There are three TNF inhibitors available; Remicade™, Enbrel™, and Humira™.  Remicade is administered once every eight weeks, Enbrel is administered twice a week, and Humira is administered once every two weeks.

Those who have rheumatoid arthritis and who have been unable to use standard anti-inflammatory agents due to ulcers, stomach problems, or other side effects, or who have been forced to stay on steroids for an inordinate period of time, should ask their doctors about the new drugs, or contact the Arthritis Center.