Rheumatoid Arthritis (RA) is a chronic disease characterized by inflammation, or swelling, in the lining of the joints that can lead to joint pain and stiffness, muscle pain, weakness and flu-like symptoms. While the exact cause of RA is unknown, it is known to be connected to the body’s immune system and is considered an autoimmune disease because people with RA have an abnormal immune system response. While the immune system normally fights infection, the immune system of someone with RA may be overactive, mistaking healthy tissue for a threat and attacking it as if it were a virus or bacteria.
The investigational drug in the ORAL trials is called CP-690,550 and is being developed as a non-biologic potential DMARD (Disease Modifying Anti-Rheumatic Drug). CP-690,550 is a pill taken by mouth, unlike many current RA treatments which are injected under the skin or infused.
Over 1,000 RA patients have been treated with CP-690,550 to date and it has been generally well-tolerated. The most frequently reported adverse events include headaches, infections and gastrointestinal symptoms such as nausea, vomiting and diarrhea: most were mild to moderate in severity and were manageable with routine medical care. These and additional potential risks are explained in detail in the informed consent document that you will receive from your physician.
CP-690,550 is not yet approved by the US Food and Drug Administration (FDA) or by any other responsible regulatory agency around the world. Regulatory agencies, including the FDA, require that before an investigational study drug can be made available to the public, it must undergo rigorous studies in a specific number of patients approved by them to determine safety, tolerability and effectiveness. The responsible regulatory agency, including the FDA in the US, has approved the procedures and processes to be followed in this study, as has the Institutional Review Board and/or Ethics Committee of the study site.