NCT05999604 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 244 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 244 participants in total. It began in 2023-11-09 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and the leading cause of severe non-traumatic disability in young people, affecting 110,000 people in France. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the rate of new T2 lesions by 80% compared with interferon-β 1a. 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05999604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05999604 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 244 participants.
Is NCT05999604 currently recruiting?
Yes, NCT05999604 is actively recruiting participants. Contact the research team at cbensa@for.paris for enrollment information.
Where is the NCT05999604 trial being conducted?
This trial is being conducted at Créteil, France, Gonesse, France, Grenoble, France, Limoges, France and 7 additional locations.
Who is sponsoring the NCT05999604 clinical trial?
NCT05999604 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 244 participants.
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