At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years inclusive
- ✓Confirmed diagnosis of primary progressive MS (PPMS) or relapsing MS (RMS) per 2017 McDonald criteria
- ✓EDSS score 0–6.5 inclusive
- ✓Eligible to receive ocrelizumab per US Package Insert
- ✕History of serious infusion reaction(s) or life-threatening infusion reaction to ocrelizumab
- ✕Known presence of other neurological disorders
- ✕Active or recent severe infection (IV antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to baseline) or hospitalization for infection
- ✕History of primary or secondary immunodeficiency or recurrent/chronic infection (HIV, syphilis, TB)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple Sclerosis
In Brief
A Phase 3 clinical trial evaluating Ocrelizumab Dose 1 and Ocrelizumab Dose 2 and Dose 3 for Multiple Sclerosis. Completed, enrolled 141 participants across 5 sites.
Detailed Summary
This study is an open-label, non-randomized study to evaluate rate and severity of infusion-related reactions (IRRs) of ocrelizumab infused over a shorter time period than the approved administration rate in participants with PPMS or RMS in the United States (U.S.). Participants will be enrolled into two cohorts. Cohort 1 will examine the effect of administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. This cohort will consist of patients who have already received one or two doses of ocrelizumab according to the approved infusion protocol (i.e., per the currently U.S. label) and have reported no serious IRRs and who will then receive the next infusion of ocrelizumab at a higher rate in order to deliver 600 mg over the course of approximately 2 hours. Cohort 2 will examine the effect of administering ocrelizumab per a shorter infusion protocol for the second infusion of Dose 1. This cohort will consist of ocrelizumab naïve patients who, after receiving Infusion 1/Dose 1 of ocrelizumab at the approved rate (300 mg over approximately 2.5 hours or longer) have no reported serious IRRs, will then receive the second 300-mg shorter infusion over approximately 1.5 hours.
Study Details
Timeline
Interventions
300 mg infusion administered to ocrelizumab-naive participants per approved protocol (over approximately 2.5 hours or longer) as per standard of care followed by a second 300 mg shorter infusion over approximately 1.5 hours.
600 mg infusion of ocrelizumab administered at a shorter rate (i.e. over the course of approximately 2 hours) at Week 24 and at Week 48