WINDOCRE
What it found
No result yet.
What was tested
Treatment tested
- Ocrelizumab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Percentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 24 months compared to inclusion MRI
MRI lesions
Other measures (14)
Relapse defined as the onset or worsening of symptoms, in the absence of fever, responsible for an increase of at least 0.5 points in the oberall EDSS score, or of 2 points in at least one functional systems of the EDSS, excluding sphincter and mental/cerebral scores
Disability progressionRelapsesDisability progression defined as an increase of >20% in Multpile Sclerosis Functional Composite (MSFC) score between inclusion and M24. Disability progression defined by an on-study increase in EDSS score of at least 1 point from baseline if EDSS at baseline was <6, or an increase of at least 0.5 points if EDSS at baseline was equal to 6
Disability progressionPercentage of NEDA 3 patients at M24: NEDA 3 (No Evidence of disease activity) corresponds to the absence of radiological activity and clinical activity : absence of relapses and disability progression
Disability progressionRelapsesPercentage of patients with at least 3 new T2 lesions on cerebro-medullary MRI at 24 months compared to the inclusion MRI
MRI lesionsNumber of new T2 lesions on cerebral-medullary MRI at 24 months compared to inclusion MRI
MRI lesionsPercentage of patients with no new or enlarged T2 lesion >3mm on cerebro-medullary MRI at 12 months compared to inclusion MRI
MRI lesionsHypogammaglobulinemia defined as a value less than 6g/L
Evolution of the gamma globulin level in plasma protein eletrophoresis between inclusion and M24
Evolution of IgG assays between inclusion and M24.
Evolution of IgM assays between inclusion and M24.
Who could take part
Relapsing and progressive · 18 and over
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: - Clinical forms of primary progressive multiple sclerosis (PP) - Pregnant woman - 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) - Planning a pregnancy within 3 years - Contra-indication to MRI - Contra-indication to the injection of contrast products - Subjects with severe or uncontrolled symptoms of renal, hepatic, haematological, gastrointestinal, pulmonary, psychiatric or cardiac disease or any uncontrolled intercurrent disease - 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
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History
Started
Nov 2023
Finished
May 2027
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