For patients with active multiple sclerosis, impact of annual versus semi-annual infusions of ocrelizumab after 2 years of initial treatment on the absence of radiological disease activity at 2 years: a multicentre randomised controlled non-inferiority trial
Key facts
- Where
- Bron, Creteil Cedex, Gonesse, Grenoble Cedex 09, Limoges Cedex 1, Nice, Paris, Paris Cedex 13, Poissy, Strasbourg Cedex 2 és Suresnes, FranciaországSee the 11 sites
- Phase
- 3. fázis
Where in Franciaország
- Hospices Civils de LyonBron, FranciaországTaking people
- Assistance Publique Hopitaux De ParisCreteil Cedex, FranciaországTaking people
- Centre Hospitalier GeneralGonesse, FranciaországTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 09, FranciaországTaking people
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Hopital Fondation Adolphe de RothschildParis, FranciaországTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranciaországTaking people
- Centre Hospitalier Intercommunal De Poissy Saint GermainPoissy, FranciaországTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex 2, FranciaországTaking people
- Hospital FochSuresnes, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hopital Fondation Adolphe De Rothschild
- Trial code
- EU 2023-505420-62-00
- Record updated
- 2026. április 7.
- Original description
To compare the efficacy of a treatment plan with annual administrations of ocrelizumab versus a conventional treatment plan with semi-annual administrations, on the absence of radiological disease activity at 2 years, in patients with active MS treated for at least 2 years with ocrelizumabRead full original descriptionShow less
To compare the efficacy of a treatment plan with annual administrations of ocrelizumab versus a conventional treatment plan with semi-annual administrations, on the absence of radiological disease activity at 2 years, in patients with active MS treated for at least 2 years with ocrelizumab
Inclusion: Patient 18 years or older; Coming for a 4th semester cycle of ocrelizumab (at least); Requires follow-up cerebral-medullary MRI as part of care; Who had relapsing remitting or secondarily progressive MS at the time of initiation of anti-CD20 (ocrelizumab or rituximab) therapy : relapse or radiological activity in the year priori to initiation of high-efficacy treatment; No relapse for at least 18 months; EDSS between 0 and 6 inclusive; Having received information about the study and having signed a consent to participate in the study; Knowledge of the French language; Affiliated or beneficiary to a social security scheme.
Exclusion: Patients already receiving routine spacing ≥ 9 months of ocrelizumab doses; Contra-indication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of a malgnant disease since the previous inhection, development of a severe immune deficiency); Subjects with severe or uncontrolled symptoms of renal, hepatic, haematological, gastrointestinal, pulmonary, psychiatric or cardiac disease or any uncontrolled intercurrent disease; Clinical forms of primary progressive multiple sclerosis (PP); Pregnant woman; Planning a pregnancy within 3 years; Contra-indication to MRI; Contra-indication to the injection of contrast products; Patient under legal protection measure; Patients of childbearing potential who do not wish to use effective contraception during their participation and at least 4 months after the last dose (oral commitment of the patient recorded in the medical file by the investigator).