Comparing annual and biannual ocrelizumab infusions for multiple sclerosis

Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial

This study is testing whether getting ocrelizumab infusions once a year or twice a year is better for people with active multiple sclerosis in keeping their disease under control over two years.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Research network)
• Drugs / interventions: ocrelizumab, immunotherapy
• Locations: 11 sites (Créteil and 10 other locations)
• Trial ID: NCT05999604 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of annual versus biannual infusions of ocrelizumab in patients with active multiple sclerosis (MS) after two years of initial treatment. The study aims to determine which infusion schedule better maintains freedom from radiological disease activity over a two-year period. Participants must have received at least three semi-annual cycles of ocrelizumab and require follow-up MRI as part of their treatment. The trial is multicenter and randomized, focusing on the safety and efficacy of different dosing intervals of this monoclonal antibody.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with active MS who have been stable for at least 18 months and are receiving their fourth semi-annual cycle of ocrelizumab.

Not a fit: Patients with primary progressive MS or those already receiving more than nine doses of ocrelizumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could optimize treatment schedules for MS patients, potentially reducing the risk of disease activity and improving long-term outcomes.

How similar studies have performed: Previous studies have shown promising results with ocrelizumab in treating MS, indicating that this approach may build on established efficacy.

Eligibility criteria

Inclusion Criteria:

1. Patient 18 years of age or older
2. Presenting for a 4th semi-annual cycle of ocrelizumab (minimum)
3. Requires follow-up MRI as part of treatment.
4. Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form)
5. Absence of relapse for at least 18 months (a relapse being defined as the appearance of new symptoms or worsening of existing symptoms, lasting more than 24 hours and outside a period of fever or an infectious episode; notified as a validated relapse by the neurologist in the patient's file, treated or not with boluses of Solu-Medrol).
6. EDSS between 0 and 6 inclusive
7. Having received informed information about the study and having signed a consent to participate in the study
8. French language proficiency
9. Affiliated or beneficiary of a social insurance scheme

Exclusion Criteria:

1. Clinical forms of primary progressive MS
2. Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart
3. Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since previous injection, development of severe immune deficiency)
4. Planned pregnancy within 3 years
5. Contraindication to MRI
6. Contraindication to injection of contrast media
7. Subject with severe or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric or cardiac disease, or any uncontrolled intercurrent pathology.
8. Patient under legal protection
9. Patients of childbearing age who do not wish to use effective contraception
10. Pregnant or breast-feeding women

Where this trial is running

Créteil and 10 other locations

• Hôpital Henri Mondor — Créteil, France (Recruiting)
• CH Gonesse — Gonesse, France (Recruiting)
• CHU de Grenoble — Grenoble, France (Recruiting)
• CHU de Limoges — Limoges, France (Recruiting)
• Hôpital Pierre Wertheimer (HCL) — Lyon, France (Recruiting)
• CHU de Nice — Nice, France (Recruiting)
• Hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
• Fondation Adolphe de Rothschild — Paris, France (Recruiting)
• CHI Poissy-Saint-Germain en Laye — Poissy, France (Recruiting)
• CHU de Strasbourg — Strasbourg, France (Recruiting)
• Hôpital Foch — Suresnes, France (Recruiting)

Study contacts

• Study coordinator: Dr Caroline Bensa

Conditions Multiple Sclerosis