2023-505420-62-00RecruitingPhase 3
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 244 (estimated)
- First submitted
- 25 Apr 2023
- Start date
- 9 Nov 2023
- Lead sponsor
- Hopital Fondation Adolphe De Rothschild
- Diseases
- Multiple sclerosis
- EU CT number
- 2023-505420-62-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 244
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active multiple sclerosis who have had at least 2 years of ocrelizumab. It compares one infusion a year with one infusion every 6 months.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Relapsing remitting or secondarily progressive MS when anti-CD20 treatment began, with a relapse or MRI activity in the year before. No relapse for at least 18 months. EDSS between 0 and 6 inclusive.
- Earlier treatment
- Coming for at least a 4th semester cycle of ocrelizumab. Started ocrelizumab or rituximab (anti-CD20) treatment earlier.
Main reasons for not taking part
- Primary progressive MS
- Pregnant, or planning a pregnancy within 3 years
- Already receiving ocrelizumab doses spaced 9 months or more apart
- Cannot continue ocrelizumab (for example hypersensitivity, active infection, cancer, severe immune deficiency)
- Cannot have an MRI or contrast injection
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Subjects with severe or uncontrolled symptoms of renal, hepatic, haematological, gastrointestinal, pulmonary, psychiatric or cardiac disease or any uncontrolled intercurrent disease
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospices Civils de Lyon | Bron | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Creteil Cedex | France | Recruiting |
| Centre Hospitalier General | Gonesse | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 09 | France | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges | Limoges Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Hopital Fondation Adolphe de Rothschild | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain | Poissy | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex 2 | France | Recruiting |
| Hospital Foch | Suresnes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.