OCT has been granted with pregnancy registry study in patients with multiple sclerosis. This will be a multi-national study. OCT will be responsible for management of 2 centers in Ukraine.
Pregnancy registry is one of the methods to monitor product safety in pregnancy. Clinical trials exclude pregnant women; thus, little is known about the human teratogenic effect of a product at the time it first enters marketing. Multiple Sclerosis is more prevalent in women of childbearing age than in any other group. That’s why MS therapy manufacturers are more and more often required to make post-marketing commitments to conduct studies of the effects of products when used during pregnancy. The drug pregnancy registries are observational studies conducted by pharmaceutical companies to track the effects of certain prescription drugs on pregnancy outcomes when mothers have been exposed to drugs. Data collected on babies born to women taking a particular medicine are compared with babies of women not taking the medicine. These studies provide important information the effect medicines have on fetal development.
The purpose of this Multi-National pregnancy exposure registry in multiple sclerosis is to monitor, evaluate, and assess major and minor teratogenic effects in women exposed to a particular drug during pregnancy in routine clinical practice. The enrollment period for this pregnancy registry is 6 years. During this time we will obtain prospectively and systematically collected data on the potential pregnancy outcome and fetal effects associated with exposure to drugs during pregnancy.
Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. It is caused by damage to the myelin, which forms the protective covering around nerve cells. When this covering is damaged, nerve impulses are slowed down or stopped. No one knows what causes MS. Globally, the median estimated incidence of MS is 2.5 per 100,000. Over 2 million people around the world have MS, including about 200000 Russians and about 20000 Ukrainians.