Status:
RECRUITING
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
Lead Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. Ocre...
Eligibility Criteria
Inclusion
- Patient 18 years of age or older
- Presenting for a 4th semi-annual cycle of ocrelizumab (minimum)
- Requires follow-up MRI as part of treatment.
- Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form)
- 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).
- EDSS between 0 and 6 inclusive
- Having received informed information about the study and having signed a consent to participate in the study
- French language proficiency
- Affiliated or beneficiary of a social insurance scheme
Exclusion
- Clinical forms of primary progressive MS
- Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart
- Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since previous injection, development of severe immune deficiency)
- Planned pregnancy within 3 years
- Contraindication to MRI
- Contraindication to injection of contrast media
- Subject with severe or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric or cardiac disease, or any uncontrolled intercurrent pathology.
- Patient under legal protection
- Patients of childbearing age who do not wish to use effective contraception
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT05999604
Start Date
November 9 2023
End Date
November 1 2027
Last Update
September 29 2025
Active Locations (1)
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1
Fondation Adolphe de Rothschild
Paris, France, 75019