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Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patients
EU CTIS ID: 2023-507431-37-00
What this study is testing
To evaluate the efficacy of ofatumumab vs first line physician’s choice DMTs for self administration in newly diagnosed/ treatment naïve RMS patient population at Month 15
- 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
- Written informed consent obtained before any assessment
- Neurologically stable within 1 month prior to first study drug administration
- Male/female patients, 18 through 55 (inclusive) years of age.
- Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al. 2018).
- Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.
- Treatment Naïve patients, ≤ 5 years since first MS symptom.
You likely can't join if
- Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
- Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
- Positive results at Screening for serological markers for hepatitis B and C
- Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
- Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures
- Conditions or treatments that may impact the safety of the patient
See the full eligibility criteria
Who can join
- Written informed consent obtained before any assessment
- Neurologically stable within 1 month prior to first study drug administration
- Male/female patients, 18 through 55 (inclusive) years of age.
- Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al. 2018).
- Relapsing MS: relapsing-course (RMS), as defined by Lublin et al 2014.
- Treatment Naïve patients, ≤ 5 years since first MS symptom.
- EDSS score: 0–4.0 (inclusive).
- Patient must be suitable to be treated with one of first line self-administered DMT physician’s choice (glatiramer acetate, IFNs, teriflunomide or DMF, according to EMA SmPC) or ofatumumab depending on randomization and physician’s choice.
- At least 1 relapse or 1 Gd+ enhanced lesion on T1 in 1 year prior to Screening.
- Able to obtain MRI assessment.
What rules you out
- Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
- Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
- Positive results at Screening for serological markers for hepatitis B and C
- Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration
- Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate or comply with the study procedures
- Conditions or treatments that may impact the safety of the patient
- Abnormal laboratory values as confirmed by the central laboratory prior to first study drug administration
- Progressive MS phenotypes
- Use of other experimental or investigational drugs
- History of hypersensitivity to the study drug or any of the excipients or to drugs of similar chemical classes
- Relapse between Screening and Baseline visits
- Pregnancy or breastfeeding
- Patients suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
- Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while receiving ofatumumab and for 6 months after the last administration. The requirements for contraception for the comparators should also be taken into consideration according to their SmPC.
- Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
- Patients with an active infection until the infection is resolved. Where local regulation requires it, SARS-Cov-19 must be ruled out by the PCR test.
- Patients with severe hypoproteinemia e.g. in nephrotic syndrome
- Patients with neurologic/psychiatric disorders prior to first study drug administration • Score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (CSSRS) if this ideation occurred in the past 6 months OR • “yes” on any item of the Suicidal Behavior section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior section) if this behavior occurred in the past 2 years.
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.