Immunotherapy register for more drug safety in MS therapy
REGIMS is an immunotherapy register in which patients are documented according to frequency, type, characteristics and consequences of side effects due to MS drugs. In addition, blood samples will be taken from these patients to search for indications as to why certain side effects developed. With these blood samples biomarkers will be identified with which therapy response or side effects can be predicted. The study will thus serve to improve drug safety in MS therapy.
The aim is to include more than 3,000 patients from 60 participating centers. At the begin of the study both the physician treating the patient as well as the patients themselves, independently of each other, will complete a questionnaire which will serve as a basic survey. Every 6 months follow-up examinations will take place during which further sociodemographic and disease-specific data as well as potential side effects will be registered. Since the patients themselves will participate in this documentation, factors such as effects on the quality of life will be included.
If severe side effects occur, the study coordinators will directly involve both the pharmaceutical manufacturer and the health authorities. The health authorities will include the Federal Institut for Drugs and Medical Devices (BfArM) as well as the Paul Ehrlich Institute (PEI).
This study will be coordinated by Prof. Dr. Klaus Berger (University of Münster).