drugset / Trial / NCT02980042

Safety of Switching From Rituximab to Ocrelizumab in MS Patients

NCT02980042

Phase 3 Completed 200 enrolled University of Colorado, Denver
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective between and within group observational study to determine differences in tolerability, immunogenicity and safety related outcomes for 100 multiple sclerosis (MS) patients who have been administered at least two infusions of rituximab, six months apart and are willing to be switched to ocrelizumab compared to a 100 patients who are continuing on rituximab as a comparison cohort from the clinic population treated as part of clinical care.

Timeline

Start
2017-01-01
Primary completion
2019-03-06
Completion
2019-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocrelizumab Monoclonal antibody 600 mg Intravenous
Comparator Rituximab Monoclonal antibody 500 mg Intravenous
Comparator Rituximab Monoclonal antibody 1000 mg Intravenous

Indications