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Monoclonal Antibodies

Subcutaneous vs Intravenous Ocrelizumab for Multiple Sclerosis (Ocarina II Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PPMS or RMS according to the revised McDonald 2017 criteria (Thompson et al. 2018)
Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 and 24
Awards & highlights

Ocarina II Trial Summary

This trial will compare the effects of two ways of administering a drug to treat MS. One group will get the drug via IV infusion, and the other group will get it via subcutaneous injection. The trial will evaluate safety, efficacy, and how the body processes the drug.

Who is the study for?
This trial is for adults with relapsing or primary progressive multiple sclerosis, as defined by the McDonald 2017 criteria. Participants should have had stable neurological conditions for at least 30 days and a disease duration of less than 15 years if their disability score is low. Women must be post-menopausal, surgically sterile, or agree to use contraception. Exclusions include recent serious infections, cancer history within ten years, immunodeficiency states, certain medication histories, pregnancy/breastfeeding intentions during the study period.Check my eligibility
What is being tested?
The trial compares subcutaneous (under the skin) injections of Ocrelizumab versus its intravenous (into a vein) infusion in patients with multiple sclerosis. It aims to assess how the body processes each method and their effects on MS symptoms and progression through blood tests, MRI scans and clinical evaluations.See study design
What are the potential side effects?
Ocrelizumab may cause side effects such as infusion reactions (like rash or fever), infections due to weakened immune response, potential liver issues indicated by blood tests changes. Other medications used like Diphenhydramine can cause drowsiness while Dexamethasone might increase appetite or cause mood swings.

Ocarina II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PPMS or RMS based on the McDonald 2017 criteria.
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My MS symptoms started less than 15 years ago and I have little to no disability.
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I can walk, with or without assistance, but not completely bedridden.

Ocarina II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum ocrelizumab area under the concentration-time curve (AUCW1-12)
Secondary outcome measures
Incidence of treatment-emergent antibodies to rHuPH20
Incidence of treatment-emergent antidrug antibodies to ocrelizumab after SC or IV administration
Maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
+4 more

Ocarina II Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ocrelizumab: Subcutaneous (SC) formulationExperimental Treatment3 Interventions
Participants will receive the first dose of ocrelizumab SC as one SC injection at a dose which is expected to result in non-inferior exposure to ocrelizumab IV. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between the first and second SC doses, and between subsequent SC doses. Participants will undergo 96 weeks of study treatment.
Group II: Ocrelizumab: Intravenous (IV) formulationActive Control3 Interventions
Participants will receive the first dose of ocrelizumab IV as two IV infusions given 14 days apart. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between SC doses. Participants will undergo 96 weeks of study treatment.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,818 Total Patients Enrolled
34 Trials studying Multiple Sclerosis
24,793 Patients Enrolled for Multiple Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,266 Total Patients Enrolled
35 Trials studying Multiple Sclerosis
18,120 Patients Enrolled for Multiple Sclerosis

Media Library

Multiple Sclerosis Clinical Trial 2023: Ocrelizumab Highlights & Side Effects. Trial Name: NCT05232825 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it risky to take Ocrelizumab SC?

"Ocrelizumab SC is a Phase 3 trial drug, which means that efficacy has been supported by some data and there are multiple rounds of safety data. Therefore, our team at Power estimates the safety to be a 3 on a scale from 1 to 3."

Answered by AI

Are new participants being accepted into this experiment?

"The clinical trial is actively recruiting participants, as data on clinicaltrials.gov indicates. The study was first posted on 5/2/2022 and was most recently updated on 10/26/2022. Currently, the study is looking for 232 patients to fill 9 available locations."

Answered by AI

How many people can join this research project?

"A total of 232 patients are required to enroll in this study, with recruitment happening across multiple sites including CIUSSS de l'Estrie-CHUS/Hopital de Granby in Granby, Quebec and The NeuroMedical Clinic of Central Louisiana in Alexandria, Louisiana."

Answered by AI

Does this research study have an age limit?

"To be eligible for this study, potential participants must 18 years old or older but not yet 65."

Answered by AI

In how many different geographical areas is this trial being conducted?

"This trial is enrolling patients at 10 different locations, including CIUSSS de l'Estrie-CHUS/Hopital de Granby in Granby, Quebec, The NeuroMedical Clinic of Central Louisiana in Alexandria, Louisiana, and Memorial Healthcare Institute for Neurosciences and Multiple sclerosis in Owosso, Michigan."

Answered by AI

Could I be a test subject for this experiment?

"The primary progressive subtype of multiple sclerosis within the age range of 18 to 65 is one of the inclusion criteria for this clinical trial which will be testing a new medication. A total of 232 patients are needed for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
2022. "A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05232825.
~76 spots leftby Apr 2025
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