The TOPIC Study is a clinical research study testing the safety and effectiveness of Teriflunomide, an oral investigational medication for those at high risk of developing multiple sclerosis (MS). This study, which is sponsored by Sanofi-Aventis, will also determine whether early treatment can reduce the severity of symptoms associated with MS.>).

Teriflunomide (Terr-eh-floo-no-mide) is derived from Leflunomide (Leh-floo-no-mide), also known as Arava®.

Arava® is already approved in many countries for the treatment of rheumatoid arthritis. Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. Teriflunomide may decrease the risk of infections compared to chemotherapy-like drugs because of its more-limited effects on the immune system (http://en.wikipedia.org/wiki/Teriflunomide)

Criteria for Participating in this Clinical Research Study
Participation requires that each person meet specific eligibility requirements of the study.

Each study participant must:
-Be in generally good health.
-Be between the ages of 18-55 years old.
-Have experienced a neurological event consistent with a diagnosis of multiple
sclerosis.
-Have experienced this possible MS symptom(s) within the last two months

These symptoms may include a clinically isolated syndrome (CIS, a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and brain magnetic resonance imaging findings suggestive of MS.

Approximately 780 patients will participate in this clinical study at 150 research centers throughout the world. For those who pass the screening process, participation requires attending regular study visits over a period of approximately 2½ years.

For a list of participating sites nationwide and to learn more about this study, please visit www.thetopicstudy.com.

This entry was posted on Thursday, June 18th, 2009 at 10:17 am and is filed under All Articles, Clinical Trials. You can follow any responses to this entry through the RSS 2.0 feed.