CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 236 enrolled
Drug / intervention
Ocrelizumab IV +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05232825
NCT05232825Phase 3Completed
CompareCT.gov

A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Hoffmann-La Roche·interventional·Posted Feb 10, 2022·Updated Aug 6, 2025

In Brief

A Phase 3 clinical trial evaluating Ocrelizumab IV, Ocrelizumab SC, and 4 other interventions for Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis. Completed, enrolled 236 participants across 37 sites in 8 countries.

Detailed Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis
CountriesBrazil, Czechia, Italy, New Zealand, Poland, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedFeb 10, 2022
Enrollment StartMay 3, 2022
Primary CompletionMar 10, 2023
Study CompletionJun 6, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.4 years ago

Interventions

Ocrelizumab IVdrug

IV Injection

Ocrelizumab SCdrug

SC Injection

Methylprednisolone IVdrug

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

Diphenhydramine IVdrug

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

Dexamethasone given orallydrug

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection

Desloratadine given orallydrug

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection