The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.
Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.
Biogen Inc (BIIB) is the sponsoring company for this trial. BiotechSign currently grades this company D (43/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.