The decision for ofatumumab as routine medical treatment must have been taken independently of and prior to the study start. During the observation phase of the study, data was collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).
The prospective observational period per patient was up to approx. one year from the time of consent (1 year ± 2 months visit window + potentially 6 months follow-up to confirm disability worsening in patients who showed increase in EDSS within 6 months prior to EOS). The observational period was not dictated by the protocol. The follow-up documentation took place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures were only those ordinarily applied to the therapeutic strategy and to routine clinical care, could be performed as telemedicine visits and took place as per investigator's discretion.
