A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)

Launched by HOFFMANN-LA ROCHE · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a treatment called ocrelizumab works for people with Multiple Sclerosis (MS) and how satisfied participants are with the treatment after a year. The study will specifically measure levels of a protein called neurofilament light chain (NfL), which can indicate nerve damage and help researchers understand the treatment's effects. Participants will complete a survey about their satisfaction with the way the treatment is given, which is through an injection under the skin.

To be eligible for the trial, participants need to have a diagnosis of MS, either relapsing forms (RMS) or primary progressive MS (PPMS), and this must be their first time receiving ocrelizumab. People who have participated in other MS treatment studies or have received certain other medications before, as well as those with severe mental health issues or who are pregnant or breastfeeding, cannot join. If you decide to participate, you will receive ocrelizumab and share your experience over the course of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of MS
• • RMS and PPMS participants diagnosed according to the McDonald criteria of 2017
• • First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab
• Exclusion Criteria:
• • Participation in interventional studies investigating DMTs for MS
• • Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site
• • Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)
• • Severe psychiatric disability
• • Pregnant and/or breastfeeding women