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 Arthritis Center’s Medical Director, 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 organizations), the team has reached the next level of sophistication.

Through CROs, which are organizations responsible for central coordination of facilities throughout the country, the Arthritis Center recruits patients and local medical practices for pharmaceutical development studies.  Every new medication brought to market must pass through these phases before the Food and Drug Administration (FDA) will approve its use.  Such studies are performed to validate claims of safety and effectiveness and are the only way to assure 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 twenty 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 on new 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 BRMs (biologic response modifiers) [need link here]. These drugs are the result of recombinant DNA research and the discovery of a class of proteins with specific biologic actions.  These proteins, called cytokines, are manufactured by body 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.

Members of the class of BRMs called TNF inhibitors are capable of decreasing the activity of TNF.  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.  Five TNF inhibitors are currently available; Remicade™, Enbrel™, Humira™, Simponi™, and Cimzia™.  Remicade is administered once every eight weeks and the others are administered more frequently.

Other BRMs are members of different classes and target lymphocytes (Orencia™, Rituxan™) or another cytokine called IL-6 (Actemra™).

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.