Trial design
ADVERSE EVENT, RECRUITMENT
This was an open‐label, single‐arm, nonrandomized study to evaluate the safety and patient experience of ocrelizumab infusion over a 2‐h period via home‐based infusion (NCT04650321). The similarly designed Phase IIIb, open‐label SaROD study of accelerated ocrelizumab infusions was used as a historical control.Eligible patients were contacted by study research coordinators and screened for potential study recruitment, then provided preliminary electronic consent through a telehealth visit (Fig. Study design. AE, adverse event; CBC, complete blood count; CMP, comprehensive metabolic panel; Ig, immunoglobulin; IRR, infusion‐related reaction; PRO, patient‐reported outcome; UCH, University of Colorado Health. Patient vitals, IRRs and any AEs were documented throughout the infusion process. Following the home infusion, research coordinators called the participants within 24 h to follow‐up on any additional AEs that they may have experienced. Electronic PRO forms similar to those completed prior to home infusion were sent a week later to assess the patient's experience with the home infusion and to reassess their general health. A final telehealth study visit was conducted with a research coordinator 2 weeks after the home infusion to collect any additional ocrelizumab‐related AEs and to close the study.This study was conducted in accordance with the current US Food and Drug Administration Good Clinical Practices and local ethical and legal requirements. All study participants provided informed consent via electronic signature prior to participation in the study.