Relapsing-Remitting Multiple Sclerosis (RRMS)Phase 3DESIRE MSNCT07189325
A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
A Phase 3 study testing Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) and Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab) in people with Relapsing-Remitting Multiple Sclerosis (RRMS) and Anti-CD20 Therapy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis (RRMS), Anti-CD20 Therapy
- What is being tested?
- Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) and Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to Jun 2031
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥40 years at inclusion
- Patients with relapsing remitting multiple sclerosis at inclusion (according to 2017 McDonald criteria) treated with anti-CD20 for at least the last 3 years. For patients treated with IV ocrelizumab or rituximab at extended interval dosing, a maximum interval of 12 months between perfusions during the year before inclusion visit is required.
- No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion)
- Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization
- Non-inclusion criteria :
- Secondary or primary progressive MS at inclusion
Show all 25Show fewer
- Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine
- Treatment with high dose corticosteroids during the 30 days preceding inclusion
- Contraindication to MRI
- Severely immunocompromised state
- Current severe active infection
- Known active malignancy
- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Severe hepatic impairment (Child-Pugh class C)
- Significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia
- Severe renal impairment undergoing dialysis
- Severe hypoproteinaemia, e.g. in nephrotic syndrome
- Current severe depression and/or suicidal ideation
- Suspected or confirmed progressive multifocal leukoencephalopathy (PML)
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
- Participation in another therapeutic trial in the last 6 months
- Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)
- All women of childbearing age not using effective contraception during the study
- Subjects not covered by public health insurance
- Failure to obtain written informed consent after a reflection period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Neurology Department, Hospital Gui de Chauliac
Montpellier, 34295
Xavier Ayrignac, Medical Doctor, +33 4 67 33 74 13, x-ayrignac@chu-montpellier.fr
Xavier Ayrignac, Medical Doctor
About this study
Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
Read more
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.
- Being tested
- Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons), Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)
- Keywords
- Multiple Sclerosis, High efficacy therapies, de-escalation, adverse events, relapses, escalation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)Drug
Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36 described below.
Patients will receive appropriate information and recommendation for the initiation of the chosen platform treatment as mention in the SmPC by treating neurologist or a member of the investigating team. If therapies are not tolerated, a therapeutic switch to other platform therapies will be possible. Any switch to a disease modifying therapy not listed as platform therapy will be considered as a major protocol deviation (see statistics).
Patients are allowed to switch from any platform DMT to another platform DMT.
Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)Drug
Patients randomized in the control group will be treated every 6 months (or at previous extended interval dosing) for patients with anti-CD20 (Ocrelizumab, Rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (Ofatumumab) from the day of randomization to M36. If therapies are not tolerated, a therapeutic switch to other anti-CD20 therapy will be possible. Any switch to a disease modifying therapy not listed as anti-CD20 therapy will be considered as major protocol deviation (see statistics).
Patients are allowed to switch from any anti-CD20 to another anti-CD20.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36. Receives: Drug: Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) |
| Control Group | Active comparator | Patients randomized in the control group will be treated every 6 months (or, up to one year, at the same interval dosing) for patients with anti-CD20 (ocrelizumab, rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (ofatumumab) from the day of randomization to M36. Receives: Drug: Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS.
Measured: From Day 0 to Month 36
New/enlarged MRI lesions
New/enlarged T2/FLAIR lesion on MRI scans to assess MRI disease activity .
Measured: From Day 0 to Month 36
Secondary outcomes (7)
Relapse
Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS
Measured: From Day 0 to Month 36
Expanded Disability Status Scale (EDSS)
EDSS to compare disability between both groups. This score is expressed from 0 (no disability) to 10 (multiple sclerosis-related death) and incorporates evaluation of the following neurological systems (pyramidal, sensory, cerebellar, sphincter, cognitive, and cranial pairs)
Measured: From Day 0 to Month 36
Brain MRI (T2/FLAIR Lesions)
MRI scans to compare new/enlarged T2/FLAIR lesions between both groups.
Measured: From Day 0 to Month 36
Number of adverse events and severe adverse events
To compare adverse events and severe adverse events between both groups.
Measured: From Day 0 to Month 36
Number of infections and serious infections
To compare infections and serious infections between both groups.
Measured: From Day 0 to Month 36
B-cell count (CD19/CD20 B cells)
B-cell count (CD19/CD20 B cells) to compare C• B-cells repopulation (CD19/CD20+ B-cells) between both groups.
Measured: From Day 0 to Month 36
Serum immunoglobulin (IgG, IgA, IgM) levels
Serum immunoglobulin (IgG, IgA, IgM) levels to compare • Immunoglobulin (IgG, A, M) levels changes between both groups.
Measured: From Day 0 to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Jun 2026
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-Remitting Multiple Sclerosis (RRMS)Studies of the same condition, open and under way.
- 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
- Multi-center, prospective, comparative, randomized into two parallel (1:1) arms, open to treatment with blinded endpoint (PROBE) non-inferiority trial comparing, over 3 years, the maintenance of anti-CD20 therapies and a de-escalation strategy: * Experimental group: Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36. * Control group: Patients randomized in the control group will be treated every 6 months (or, up to one year, at the same interval dosing) for patients with anti-CD20 (ocrelizumab, rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (ofatumumab) from the day of randomization to M36. In both groups, each patient will have a treating neurologist and a blinded examinator who will perform blinded EDSS evaluations and assessment of suspected relapses.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189325
- Sponsor's protocol ID
- RECHMPL23_0397
- Other IDs
- 2024-513292-40-00
- Acronym
- DESIRE MS
- Status last verified
- Jun 2026
- First submitted
- 23 Jul 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07189325
- Acronym / sponsor ID
- DESIRE MS / RECHMPL23_0397
- Keywords
- Multiple Sclerosis, High efficacy therapies, de-escalation, adverse events, relapses, escalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 23 Sep 2025 (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), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, prospective, comparative, randomized into two parallel (1:1) arms, open to treatment with blinded endpoint (PROBE) non-inferiority trial comparing, over 3 years, the maintenance of anti-CD20 therapies and a de-escalation strategy: * Experimental group: Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36. * Control group: Patients randomized in the control group will be treated every 6 months (or, up to one year, at the same interval dosing) for patients with anti-CD20 (ocrelizumab, rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (ofatumumab) from the day of randomization to M36. In both groups, each patient will have a treating neurologist and a blinded examinator who will perform blinded EDSS evaluations and assessment of suspected relapses.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36. |
| Control Group | Active comparator | Drug: Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)Patients randomized in the control group will be treated every 6 months (or, up to one year, at the same interval dosing) for patients with anti-CD20 (ocrelizumab, rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (ofatumumab) from the day of randomization to M36. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients ≥40 years at inclusion
- Patients with relapsing remitting multiple sclerosis at inclusion (according to 2017 McDonald criteria) treated with anti-CD20 for at least the last 3 years. For patients treated with IV ocrelizumab or rituximab at extended interval dosing, a maximum interval of 12 months between perfusions during the year before inclusion visit is required.
- No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion)
- Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization
- Secondary or primary progressive MS at inclusion
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 |
|---|---|---|
| Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) according to treatments' authorization from the day of randomization to M36 described below. Patients will receive appropriate information and recommendation for the initiation of the chosen platform treatment as mention in the SmPC by treating neurologist or a member of the investigating team. If therapies are not tolerated, a therapeutic switch to other platform therapies will be possible. Any switch to a disease modifying therapy not listed as platform therapy will be considered as a major protocol deviation (see statistics). Patients are allowed to switch from any platform DMT to another platform DMT. | Drug | Experimental Group |
| Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)Patients randomized in the control group will be treated every 6 months (or at previous extended interval dosing) for patients with anti-CD20 (Ocrelizumab, Rituximab) or every 4 weeks for patients with subcutaneous anti-CD20 (Ofatumumab) from the day of randomization to M36. If therapies are not tolerated, a therapeutic switch to other anti-CD20 therapy will be possible. Any switch to a disease modifying therapy not listed as anti-CD20 therapy will be considered as major protocol deviation (see statistics). Patients are allowed to switch from any anti-CD20 to another anti-CD20. | Drug | Control Group |
Primary outcome
Relapse
Time frame: From Day 0 to Month 36
Presence of at least one clinical relapse defined as new or worsening symptoms related to MS resulting in objective signs on neurological examination in the absence of any potential trigger not related to MS.
New/enlarged MRI lesions
Time frame: From Day 0 to Month 36
New/enlarged T2/FLAIR lesion on MRI scans to assess MRI disease activity .
7 secondary outcomes
Relapse
Time frame: From Day 0 to Month 36
Expanded Disability Status Scale (EDSS)
Time frame: From Day 0 to Month 36
Brain MRI (T2/FLAIR Lesions)
Time frame: From Day 0 to Month 36
Number of adverse events and severe adverse events
Time frame: From Day 0 to Month 36
Number of infections and serious infections
Time frame: From Day 0 to Month 36
B-cell count (CD19/CD20 B cells)
Time frame: From Day 0 to Month 36
Serum immunoglobulin (IgG, IgA, IgM) levels
Time frame: From Day 0 to Month 36
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 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) and Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab) in people with Relapsing-Remitting Multiple Sclerosis (RRMS) and Anti-CD20 Therapy, run by University Hospital, Montpellier at 1 site 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 25 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xavier AYRIGNAC, Medical Doctor (+33 4 67 33 74 13, x-ayrignac@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: From Day 0 to Month 36). The study lists 2 primary outcomes in all. 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 23 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.