Multiple SclerosisPhase 3WINDOCRENCT05999604
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
A Phase 3 study testing Ocrelizumab Injection [Ocrevus] in people with Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab Injection [Ocrevus]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 11 sitesFrance
- Study dates
- 9 Nov 2023to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital Henri Mondor
Créteil, 94010
CH Gonesse
Gonesse, 95500
CHU de Grenoble
Grenoble, 38043
CHU de Limoges
Limoges, 87042
Hôpital Pierre Wertheimer (HCL)
Lyon, 69500
CHU de Nice
Nice, 06000
Hôpital de la Pitié-Salpêtrière
Paris, 75013
Fondation Adolphe de Rothschild
Paris, 75019
CHI Poissy-Saint-Germain en Laye
Poissy, 78300
CHU de Strasbourg
Strasbourg, 67098
Hôpital Foch
Suresnes, 92150
About this study
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. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the rate of new T2 lesions by 80% compared with interferon-β 1a.
The use of anti-CD20 agents, including ocrelizumab, is associated with an infectious risk that increases with duration of exposure, part of which is due to the development of hypo-gammaglobulinemia in relation to cumulative dose.
Read more
Several reports suggest a persistent effect of anti-CD20 drugs in MS, with no resumption of inflammatory activity after discontinuation:
- During the development of ocrelizumab, at the end of phase 2, after having received 3 or 4 semi-annual cycles of ocrelizumab, a safety period with a therapeutic window of 18 months was planned, before re-administration in the extension study. During this therapeutic window, the annualized relapse rate remained stable, and patients showed no radiological disease activity.
- Scandinavian observational studies of "off-label" use of anti-CD20 in MS provide real-life evidence of the absence of recovery of clinical and radiological activity after prolonged interruption of treatment.
After 2 years of treatment, and with disease activity under control, spacing administration intervals could reduce the risk of infection without reducing treatment efficacy. This would facilitate the decision to maintain highly active immunotherapy over the long term. In addition, this therapeutic de-escalation, by reducing the frequency of infusions and associated day hospitalizations, would help to reduce treatment management costs.
Our aim is to evaluate the non-inferiority of 12-monthly spacing of ocrelizumab infusions versus the conventional 6-monthly regimen, in a population of active MS patients over 18 years of age who have already received 4 or more semi-annual cycles of treatment for 2 years.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab Injection [Ocrevus]
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab Injection [Ocrevus]Drug
Semestrial administration
Ocrelizumab Injection [Ocrevus]Drug
Annual administration
| Study group | Role | What they receive |
|---|---|---|
| annual ocrelizumab infusions | Experimental | Not described Receives: Drug: Ocrelizumab Injection [Ocrevus] |
| semestrial ocrelizumab infusions | Other | Not described Receives: Drug: Ocrelizumab Injection [Ocrevus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of radiological disease activity at 2 years
Percentage of patients with no new or enlarged T2 lesion >3mm on cerebrospinal MRI at 24 months compared with inclusion MRI.
MRI readings at inclusion and M24 will be performed by an independent radiologist blinded to the treatment arm.
Measured: Months24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Nov 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999604
- Sponsor's protocol ID
- CBR_2022_13
- Acronym
- WINDOCRE
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05999604
- Acronym / sponsor ID
- WINDOCRE / CBR_2022_13
- Conditions
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the rate of new T2 lesions by 80% compared with interferon-β 1a.
The use of anti-CD20 agents, including ocrelizumab, is associated with an infectious risk that increases with duration of exposure, part of which is due to the development of hypo-gammaglobulinemia in relation to cumulative dose.
Several reports suggest a persistent effect of anti-CD20 drugs in MS, with no resumption of inflammatory activity after discontinuation:
- During the development of ocrelizumab, at the end of phase 2, after having received 3 or 4 semi-annual cycles of ocrelizumab, a safety period with a therapeutic window of 18 months was planned, before re-administration in the extension study. During this therapeutic window, the annualized relapse rate remained stable, and patients showed no radiological disease activity.
- Scandinavian observational studies of "off-label" use of anti-CD20 in MS provide real-life evidence of the absence of recovery of clinical and radiological activity after prolonged interruption of treatment.
After 2 years of treatment, and with disease activity under control, spacing administration intervals could reduce the risk of infection without reducing treatment efficacy. This would facilitate the decision to maintain highly active immunotherapy over the long term. In addition, this therapeutic de-escalation, by reducing the frequency of infusions and associated day hospitalizations, would help to reduce treatment management costs.
Our aim is to evaluate the non-inferiority of 12-monthly spacing of ocrelizumab infusions versus the conventional 6-monthly regimen, in a population of active MS patients over 18 years of age who have already received 4 or more semi-annual cycles of treatment for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| annual ocrelizumab infusions | Experimental | Drug: Ocrelizumab Injection [Ocrevus] |
| semestrial ocrelizumab infusions | Other | Drug: Ocrelizumab Injection [Ocrevus] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocrelizumab Injection [Ocrevus]Semestrial administration | Drug | semestrial ocrelizumab infusions |
| Ocrelizumab Injection [Ocrevus]Annual administration | Drug | annual ocrelizumab infusions |
Primary outcome
Absence of radiological disease activity at 2 years
Time frame: Months24
Percentage of patients with no new or enlarged T2 lesion >3mm on cerebrospinal MRI at 24 months compared with inclusion MRI. MRI readings at inclusion and M24 will be performed by an independent radiologist blinded to the treatment arm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ocrelizumab Injection [Ocrevus] in people with Multiple Sclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of radiological disease activity at 2 years (time frame: Months24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.