A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab
Johns Hopkins University
Summary
The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a "wearing off" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with relapsing forms of MS. * Age between 18 and 65 years old (inclusive). * On treatment with standard interval ocrelizumab for at least one year. * Eligible and willing to continue treatment with ocrelizumab or ublituximab. * The presence of wearing off phenomena, defined as either worsening in any Neuro-QoL sleep disturbance, fatigue, depression, upper and lower extremity scores (moving from a lower category of symptom severity to a higher category, based on previously defined cutoff scores), a worsening of Neuro-QoL score of 10 points (which equals 1 SD) or…
Interventions
- DrugUblituximab
Ublituzimab will be administered via IV infusion as specified throughout the study period.
- DrugOcrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Location
- Johns Hopkins UniversityBaltimore, Maryland