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
EU CTIS ID: 2023-505420-62-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.