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TRIO: A prospective randomized Trial of non-inferiority comparing RItuximab versus Ocrelizumab in relapsing-remitting multiple sclerosis.
EU CTIS ID: 2022-501027-25-01
What this study is testing
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 III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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)
- - Having signed an informed consent form
You likely can't join if
- - Secondary or primary progressive MS;
- - Incapacity to understand or sign the consent form;
- - Contraindication to MRI
- - Previous treatment by fingolimod or natalizumab in the last 4 weeks
- - 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
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 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)
- - Having signed an informed consent form
- - Patients covered with social insurance
- - Secondary or primary progressive MS;
- - Incapacity to understand or sign the consent form;
- - Contraindication to MRI
- - Previous treatment by fingolimod or natalizumab in the last 4 weeks
- - 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
- - Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;
- - 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;
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.