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Compares treatment options for Relapsing-Remitting Multiple Sclerosis (RRMS)
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
What this study is testing
What is Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)?
Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsing-remitting multiple sclerosis (rrms).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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-
- Secondary or primary progressive MS at inclusion
See the full eligibility criteria
- 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...
- 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-
- Secondary or primary progressive MS at inclusion
- 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
- people not covered by public health insurance
- Failure to obtain written informed consent after a reflection period
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, 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 - 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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, 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 - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.