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Compares treatment options for Multiple Sclerosis
Official title RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
ClinicalTrials.gov ID: NCT05758831
What this study is testing
What is Perfusion of treatment Rituximab?
Perfusion of treatment Rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
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
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 18 to 55
You may be able to join if
- Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least...
- 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...
See the full eligibility criteria
- 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...
- 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...
- Having signed an informed consent form
- Patients covered with social insurance Non-
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, Bron, France
- Brest, France
- Caen, France
- Cergy-Pontoise, France
- Clermont-Ferrand, France
- Gonesse, France
- Lille, France
- Limoges, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nantes, France
- Nice, France
- Nîmes, France
- Paris, France
- Poissy, France
- Quimper, France
- Rennes, France
- Rouen, France
- Strasbourg, France
+ 2 more site(s).
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, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, Bron, France; Brest, France; Caen, France; Cergy-Pontoise, France; Clermont-Ferrand, France; Gonesse, France and 16 more location(s). 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.