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
NCT ID: NCT05999604
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
244 participants
INTERVENTIONAL
2023-11-09
2029-11-30
Brief Summary
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The use of anti-CD20 agents, including ocrelizumab, is associated with an infectious risk that increases with duration of exposure, part of which is due to the development of hypo-gammaglobulinemia in relation to cumulative dose.
Several reports suggest a persistent effect of anti-CD20 drugs in MS, with no resumption of inflammatory activity after discontinuation:
* During the development of ocrelizumab, at the end of phase 2, after having received 3 or 4 semi-annual cycles of ocrelizumab, a safety period with a therapeutic window of 18 months was planned, before re-administration in the extension study. During this therapeutic window, the annualized relapse rate remained stable, and patients showed no radiological disease activity.
* Scandinavian observational studies of "off-label" use of anti-CD20 in MS provide real-life evidence of the absence of recovery of clinical and radiological activity after prolonged interruption of treatment.
After 2 years of treatment, and with disease activity under control, spacing administration intervals could reduce the risk of infection without reducing treatment efficacy. This would facilitate the decision to maintain highly active immunotherapy over the long term. In addition, this therapeutic de-escalation, by reducing the frequency of infusions and associated day hospitalizations, would help to reduce treatment management costs.
Our aim is to evaluate the non-inferiority of 12-monthly spacing of ocrelizumab infusions versus the conventional 6-monthly regimen, in a population of active MS patients over 18 years of age who have already received 4 or more semi-annual cycles of treatment for 2 years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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annual ocrelizumab infusions
Ocrelizumab Injection [Ocrevus]
Annual administration
semestrial ocrelizumab infusions
Ocrelizumab Injection [Ocrevus]
Semestrial administration
Interventions
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Ocrelizumab Injection [Ocrevus]
Semestrial administration
Ocrelizumab Injection [Ocrevus]
Annual administration
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Hôpital Henri Mondor
Créteil, , France
CH Gonesse
Gonesse, , France
CHU de Grenoble
Grenoble, , France
CHU de Limoges
Limoges, , France
Hôpital Pierre Wertheimer (HCL)
Lyon, , France
CHU de Nice
Nice, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
Fondation Adolphe de Rothschild
Paris, , France
CHI Poissy-Saint-Germain en Laye
Poissy, , France
CHU de Strasbourg
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CBR_2022_13
Identifier Type: -
Identifier Source: org_study_id
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