Multiple SclerosisPhase 3TRIONCT05758831
RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
A Phase 3 study testing Perfusion of treatment Rituximab and Perfusion of treatment Ocrelizumab in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis, run by Rennes University Hospital at 23 sites in France.
Trial summary
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Perfusion of treatment Rituximab and Perfusion of treatment Ocrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 23 sitesFrance
- Study dates
- 1 Jun 2023to 1 May 2030
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);
- Age between 18 and 55 years
- EDSS ≤ 5
- Brain MRI within 6 months before inclusion
- For women of childbearing potential*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate <1%, for the duration of the study and until 12 months after last dose administered) * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
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- Having signed an informed consent form
- Patients covered with social insurance
- Non-Inclusion Criteria:
- Secondary or primary progressive MS;
- Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;
- Previous treatment by fingolimod or natalizumab in the last 4 weeks;
- Treatment with high dose corticosteroids during the 30 days preceding the inclusion;
- Occurrence of a relapse less than 30 days before inclusion;
- Pregnancy or breastfeeding;
- Other neurologic or systemic disease;
- Concomitant participation or Participation in another therapeutic trial in the last 6 months;
- Incapacity to understand or sign the consent form;
- Contraindication to MRI;
- Contraindication to anti-CD20 therapies:
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
- Active malignancy.
- Any ongoing infection
- Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease
- Positive test for HIV, hepatitis B or C, or tuberculosis
- Severe immune deficiency:
- Lymphopenia grade 3 (0.2 to 0.5 × 10^9/L) or higher grades
- Neutropenia grade 3 (0.5 to 1.0 × 10^9/L) or higher grades
- Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids
- AST or ALT >=3ULN
- Platelet (thrombocyte) count < 100 x 10^9/L
- Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
Who cannot join
None listed.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
France23 sites, 23 recruiting
- Not yet recruiting
CHRU de Brest - Hôpital la Cavale Blanche
Brest, 29609
Aurore JOURDAIN, MD, aurore.jourdain@chu-brest.fr
- Recruiting
Centre Hospitalier Universitaire de Caen
Caen, 14033
Gilles DEFER, MD, defer-gi@chu-caen.fr
- Not yet recruiting
Centre Hospitalier de Pontoise - GHT NOVO
Cergy-Pontoise, 95300
Philippe NICLOT, MD, philipe.niclot@ght-novo.fr
- Not yet recruiting
Hôpital Gabriel Montpieds
Clermont-Ferrand, 63003
Pierre CLAVELOU, MD, pclavelou@chu-clermont-ferrand.fr
- Not yet recruiting
Centre hospitalier de Gonnesse
Gonesse, 95503
Eric MANCHON, MD, eric.manchon@ch-gonessse.fr
- Not yet recruiting
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, 59160
Julien POUPARD, MD, poupart.julien@ghicl.net
- Not yet recruiting
Centre Hospitalier Universitaire de Limoges
Limoges, 87042
Laurent MAGY, MD, laurent.magy@chu-limoges.fr
- Not yet recruiting
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
Lyon, Bron, 69677
Sandra VUKUSIC, MD, sandra.vukusic@chu-lyon.fr
- Recruiting
AP-HM - Hôpital la Timone
Marseille, 13385
Bertrand AUDOIN, MD, bertrand.audoin@ap-hm.fr
- Recruiting
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
Pierre LABAUGE, MD, labauge@yahoo.fr
- Recruiting
Centre Hospitalier Régional de Nancy
Nancy, 54035
Guillaume MATHEY, MD, g.mathey@chrudenancy.fr
- Recruiting
CHU de Nantes -Hôpital Nord Laennec
Nantes, 44800
David LAPLAUD, MD, david.laplaud@chu-nantes.fr
- Recruiting
CHU de Nice - Hôpital Pasteur 2
Nice, 06002
Christine LEBRUN-FRENAY, MD, lebrun.frenay.c@chu-nice.fr
- Not yet recruiting
CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029
Eric THOUVENOT, MD, eric.thounevot@chu-nimes.fr
- Not yet recruiting
AP-HP Höpital la Pitié-Salpétrière
Paris, 75010
Céline LOUAPRE, MD, celine.louapre@aphp.fr
- Not yet recruiting
Groupe Hospitalier Universitaire Henri Mondor
Paris, 94000
Alain CREANGE, MD, alain.creange@aphp.fr
- Not yet recruiting
Hôpital Saint-Germain
Poissy, 78303
Olivier HEINZLEF, MD, oheinzlef@chi-poissy-st-germain.fr
- Recruiting
Centre Hospitalier de Cornouaille
Quimper, 29107
Marc COUSTANS, MD, m.coutains@ch-cornouaille.fr
- Recruiting
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, 35000
Laure MICHEL, MD
Laure MICHEL, PH-PD
- Not yet recruiting
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76038
Bertrand BOURRE, MD, bertrand.bourre@chu-rouen.fr
- Recruiting
CHRU de Strasbourg - Hôpital Hautpierre
Strasbourg, 67200
Jérôme DE SEZE, MD, jerome.de.seze@chru-strasbourg.fr
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
TCHIKVILADZE Maia, MD, m.tchikviladze@hopital-foch.com
- Not yet recruiting
CHU de Toulouse - Bâtiment Pierre Paul Riquet
Toulouse, 31059
Jonathan CIRON, MD, ciron.j@chu-toulouse.fr
About this study
Official title: A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.
During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months).
Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
Read the detailed description
Multiple sclerosis (MS) is an autoimmune inflammatory disease of the central nervous system (CNS). This disease is the leading cause of non-traumatic disability in young adults and France is characterized by a high prevalence (currently 1/1000 inhabitants) of MS.
Clinical trials with B cell depleting therapies have shown efficacy in relapsing-remitting MS (RRMS) and are increasingly perceived as an important addition to the existing panel of Disease-modifying treatments (DMTs). Rituximab, a mouse chimeric anti CD20, is approved for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, certain forms of vasculitis and Rheumatoid Arthritis with first marketing approval in 1998. Rituximab has undergone clinical testing in RRMS in 2008 in a phase II placebo-controlled trial, demonstrating the clinico-radiological efficacy in 104 patients. Despite these promising results and the absence of adverse events, its clinical development was interrupted by the manufacturer (Roche). However, for several years, rituximab has been increasingly prescribed (off-label) in Europe and USA in patients refractory to first-line therapies, with a very good safety and efficacy. Thus, rituximab is prescribed for 40% of RRMS patients treated in Sweden. Roche has then developed a humanized anti-CD20 monoclonal antibody (Ocrelizumab). Two phase III clinical trials (OPERA I and II) have demonstrated its efficacy in active RRMS. Ocrelizumab has just been authorized in France in this indication: RRMS patients with active disease (clinical or radiological). So, it can be prescribed as a first line or second line therapy in active RRMS patients.
According to literature, there are no biological arguments to think that ocrelizumab could be more effective in active RRMS compared to rituximab. Moreover, regarding safety, rituximab has been used for other indications for almost two decades and no serious concern has arisen.
The high cost of this new antibody (x6 to 10) compared to rituximab) makes it wonder about its place inside the anti-CD20 therapeutic strategy compared to rituximab for treating relapsing MS patients.
Hypothesis: Researchers hypothesize that rituximab and ocrelizumab have the same efficacy in active RRMS patients. Indeed, if the non-inferiority of rituximab on the % of patients without disease activity is confirmed by the trial, the potential medico-economic benefit from a societal perspective will be a strong argument to ask for authorization of rituximab in active RRMS.
- Being tested
- Perfusion of treatment Rituximab, Perfusion of treatment Ocrelizumab
- Keywords
- Multiple Sclerosis, Relapsing-remitting
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion of treatment RituximabDrug
Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Perfusion of treatment OcrelizumabDrug
Perfusion of treatment (Ocrevus®)
| Study group | Role | What they receive |
|---|---|---|
| Ocrelizumab | Active comparator | Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24) Receives: Drug: Perfusion of treatment Ocrelizumab |
| Rituximab | Experimental | Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24) Receives: Drug: Perfusion of treatment Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years.
Percentage of patients without disease activity at 2 years (Disease activity is defined as:
- At least one relapse between baseline and M24
- OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)
Measured: at 2 years
Secondary outcomes (16)
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate
Relapses: annualized relapse rate
Measured: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse
mean time of onset of the first relapse
Measured: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse
Percentage of patients without relapse
Measured: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression
Percentage of patients without disability progression (Expanded Disability Status Scale-EDSS) (Disability progression will be defined as an increase of 1.5 pt if baseline EDSS=0, 1pt EDSS (if baseline 1 ≤ EDSS<6), or an increase of 0.5pt if baseline EDSS is ≥ 6; confirmed at 6 months.) EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome.
Measured: at 2 years
MRI parameters : gadolinium (Gd) enhancing lesions
- Mean number of Gd enhancing lesions at M6
Measured: at 6 month
MRI parameters : gadolinium (Gd) enhancing lesions
- Percentage of patients with at least one Gd enhancing lesion(s)
Measured: at 6 month
MRI parameters : Mean Number of new T2 lesions
- Mean number of new brain T2 lesions
Measured: From Month 6 to Month 24
MRI parameters : Percentage of patients with one or more new T2 lesions
- Percentage of patients with one or more new brain T2 lesions
Measured: From Month 6 to Month 24
Patients quality of life : EQ-5D-5L
Change in the EQ-5D-5L score
The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: From baseline (Day 0) to every six month of follow up until Month 24
Patients quality of life : MusiQOL (Multiple Sclerosis International Quality of Life questionnaire)
Change in the MusiQOL score
The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1):
activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two).
Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Measured: From baseline (Day 0) to Month 12
Patients quality of life : MusiQOL
Change in the MusiQOL score
The MusiQoL is a specific questionnaire comprising 31 questions describing nine dimensions of quality of life (Appendix 1):
activities of daily living (eight items); psychological well-being (four); relationships with friends (four); symptoms (three); relationships with family (three); relationships with the health care system (three); emotional and sexual life (two); coping (two); rejection (two).
Each item is scored from 1 (never/not at all) to 5 (always/very much). Before calculating the score of the dimensions, the scores of negatively written items are reversed. The score of a dimension is obtained by averaging the scores of its constituent items. The dimension scores are then transformed linearly into scores ranging from 0 to 100 (100 being the maximum quality of life level). A global quality of life score is also available.
Measured: From baseline (Day 0) to Month 24
Patients experience : Musicare
Change in the Musicare score
Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3).
Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Measured: From baseline (Day 0) to Month 12
Patients experience : Musicare
Change in the Musicare score
Musicare is a questionnaire to assess the experience of both patients and caregivers of quality of care in MS, in accordance with psychometric standards. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3).
Each item is scored from 1 (Strongly agree) to 5 (Don't know).
Measured: From baseline (Day 0) to Month 24
Medico-economic impact: cost-utility ratio, QALY
Incremental Cost-Effectiveness Ratio (ICER) defined as the cost for QALY gained in "ocrelizumab group" versus "rituximab group" at 24 months.
Measured: At 2 years
Safety: Number of each adverse event
Number of each adverse event will be compared between the two groups
Measured: At 2 years
Safety: Number of each severe adverse events
Number of each severe adverse events will be compared between the two groups
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jun 2023
- Primary completion31 Mar 2030 (estimated)
- Study completion1 May 2030 (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 Rennes University HospitalThe 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
- Model description
- multicenter, prospective, comparative (non inferiority), randomized, double blinded phase III/IV study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758831
- Sponsor's protocol ID
- 35RC20_9812_TRIO
- Acronym
- TRIO
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2023
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05758831
- Acronym / sponsor ID
- TRIO / 35RC20_9812_TRIO
- Keywords
- Multiple Sclerosis, Relapsing-remitting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 7 Mar 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.
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.
During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months).
Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
Detailed description
Multiple sclerosis (MS) is an autoimmune inflammatory disease of the central nervous system (CNS). This disease is the leading cause of non-traumatic disability in young adults and France is characterized by a high prevalence (currently 1/1000 inhabitants) of MS.
Clinical trials with B cell depleting therapies have shown efficacy in relapsing-remitting MS (RRMS) and are increasingly perceived as an important addition to the existing panel of Disease-modifying treatments (DMTs). Rituximab, a mouse chimeric anti CD20, is approved for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, certain forms of vasculitis and Rheumatoid Arthritis with first marketing approval in 1998. Rituximab has undergone clinical testing in RRMS in 2008 in a phase II placebo-controlled trial, demonstrating the clinico-radiological efficacy in 104 patients. Despite these promising results and the absence of adverse events, its clinical development was interrupted by the manufacturer (Roche). However, for several years, rituximab has been increasingly prescribed (off-label) in Europe and USA in patients refractory to first-line therapies, with a very good safety and efficacy. Thus, rituximab is prescribed for 40% of RRMS patients treated in Sweden. Roche has then developed a humanized anti-CD20 monoclonal antibody (Ocrelizumab). Two phase III clinical trials (OPERA I and II) have demonstrated its efficacy in active RRMS. Ocrelizumab has just been authorized in France in this indication: RRMS patients with active disease (clinical or radiological). So, it can be prescribed as a first line or second line therapy in active RRMS patients.
According to literature, there are no biological arguments to think that ocrelizumab could be more effective in active RRMS compared to rituximab. Moreover, regarding safety, rituximab has been used for other indications for almost two decades and no serious concern has arisen.
The high cost of this new antibody (x6 to 10) compared to rituximab) makes it wonder about its place inside the anti-CD20 therapeutic strategy compared to rituximab for treating relapsing MS patients.
Hypothesis: Researchers hypothesize that rituximab and ocrelizumab have the same efficacy in active RRMS patients. Indeed, if the non-inferiority of rituximab on the % of patients without disease activity is confirmed by the trial, the potential medico-economic benefit from a societal perspective will be a strong argument to ask for authorization of rituximab in active RRMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, prospective, comparative (non inferiority), randomized, double blinded phase III/IV study
| Arm | Type | Receives |
|---|---|---|
| Ocrelizumab | Active comparator | Drug: Perfusion of treatment OcrelizumabDay 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24) |
| Rituximab | Experimental | Drug: Perfusion of treatment RituximabDay 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);
- Age between 18 and 55 years
- EDSS ≤ 5
- Brain MRI within 6 months before inclusion
- For women of childbearing potential*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate <1%, for the duration of the study and until 12 months after last dose administered) * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Perfusion of treatment RituximabPerfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®) | Drug | Rituximab |
| Perfusion of treatment OcrelizumabPerfusion of treatment (Ocrevus®) | Drug | Ocrelizumab |
Primary outcome
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years.
Time frame: at 2 years
Percentage of patients without disease activity at 2 years (Disease activity is defined as: * At least one relapse between baseline and M24 * OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)
16 secondary outcomes
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate
Time frame: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse
Time frame: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse
Time frame: at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression
Time frame: at 2 years
MRI parameters : gadolinium (Gd) enhancing lesions
Time frame: at 6 month
MRI parameters : gadolinium (Gd) enhancing lesions
Time frame: at 6 month
MRI parameters : Mean Number of new T2 lesions
Time frame: From Month 6 to Month 24
MRI parameters : Percentage of patients with one or more new T2 lesions
Time frame: From Month 6 to Month 24
Patients quality of life : EQ-5D-5L
Time frame: From baseline (Day 0) to every six month of follow up until Month 24
Patients quality of life : MusiQOL (Multiple Sclerosis International Quality of Life questionnaire)
Time frame: From baseline (Day 0) to Month 12
Patients quality of life : MusiQOL
Time frame: From baseline (Day 0) to Month 24
Patients experience : Musicare
Time frame: From baseline (Day 0) to Month 12
Patients experience : Musicare
Time frame: From baseline (Day 0) to Month 24
Medico-economic impact: cost-utility ratio, QALY
Time frame: At 2 years
Safety: Number of each adverse event
Time frame: At 2 years
Safety: Number of each severe adverse events
Time frame: At 2 years
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 2 Feb 2026.
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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.
23 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 Perfusion of treatment Rituximab and Perfusion of treatment Ocrelizumab in people with Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis, run by Rennes University Hospital at 23 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 32 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Contact Laure MICHEL, MD (0299286774, laure.michel@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years. (time frame: at 2 years). 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 2 Feb 2026.