BridgeMD
Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease (OVERLORD-MS)
EU CTIS ID: 2024-510716-71-00
What this study is testing
This is a multicenter non-inferiority study, designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years.
- Therapeutic confirmatory (Phase III)
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
- A diagnosis of RRMS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months.
- REDUCE: Stable disease, defined as no relapse3 or new MRI lesion4 during the last 24 months before enrollment
- REDUCE: Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration ofmonths after last dose administered to comply with CTFG Contraception guidance Version 1.1 (CTFG 21/09/2020).
- REDUCE: Absence of comorbidity or drug abuse that preclude study participation
- REDUCE: Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)
- REDUCE: . Able to understand written and spoken Norwegian or Swedish
You likely can't join if
- A diagnosis of progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)
- Previous MS therapy
- Comorbidity that is not compatible with B cell depletion therapy
- Blood screening results (i.e. hematology, chemistry, infection) that is not compatible with B cell depletion therapy
- Comorbidity that otherwise preclude study participation
- Pregnancy or lactating female patients
See the full eligibility criteria
- A diagnosis of RRMS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months.
- REDUCE: Stable disease, defined as no relapse3 or new MRI lesion4 during the last 24 months before enrollment
- REDUCE: Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration ofmonths after last dose administered to comply with CTFG Contraception guidance Version 1.1 (CTFG 21/09/2020).
- REDUCE: Absence of comorbidity or drug abuse that preclude study participation
- REDUCE: Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)
- REDUCE: . Able to understand written and spoken Norwegian or Swedish
- REDUCE: Capable of giving signed informed consent as described in Appendix 1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Treatment naïve patients aged between 18 and 60 years included
- Disease activity defined as ≥ 1 relapse1 or ≥ 1 new MRI lesion2 during the last 12 months
- EDSS score ≤ 4.0
- Absence of comorbidity that preclude study participation
- Written informed consent for study participation
- Able to understand written and spoken Norwegian or Swedish
- Able to complete treatment or follow-ups in the study (e.g. no contraindications for MRI, plans of moving)
- REDUCE: Previously enrolled in and completed the OVERLORD-MS trial and OVERLORD-SWITCH study
- A diagnosis of progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)
- Previous MS therapy
- Comorbidity that is not compatible with B cell depletion therapy
- Blood screening results (i.e. hematology, chemistry, infection) that is not compatible with B cell depletion therapy
- Comorbidity that otherwise preclude study participation
- Pregnancy or lactating female patients
- REDUCE: Any disease that is a contraindication to treatment with rituximab (as described in the SMPC)
- REDUCE: Not longer treated with rituximab (e.g. switched to another treatment for MS or stopped MStreatme
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.