An open-label study evaluating ofatumumab treatment effectiveness andPROs in subjects with RMS transitioning from fumarate-based RMSapproved therapies or fingolimod to ofatumumab
- Conditions
- Multiple sclerosisMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-001341-40-SK
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 555
• Diagnosis of MS according to the 2017 Revised McDonald criteria
• Relapsing MS: relapsing forms of MS (RMS) including RMS and
secondary progressive MS (SPMS) (Lublin et al 2014)
• Disability status at screening defined by Expanded Disability Status
Scale (EDSS) score of 0 to 4 (inclusive)
• MS treatment history with a maximum of 3 Disease Modifying
Therapies (DMTs), where all fumarates are considered as one DMT
• Subject transitioning from either any fumarate-based RMS approved
therapies, such as dimethyl fumarate (DMF) or diroximel fumarate
(DRF), or fingolimod which was administered for a period of at least 6
months, as their last DMT before first study drug administration
• Breakthrough disease activity while the participant was adequately
using fumarates or fingolimod prior to transitioning for a minimum of 6
months as evidenced by one or more clinically reported relapses or one
or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+
enhancement, new or enlarging T2 lesions)
• Neurologically stable within one month prior to first study drug
administration
Please see protocol for complete detailed list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Subjects with primary progressive MS (Polman et al 2011) or SPMS
without disease activity (Lublin et al 2014)
• Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al
2015)
• Disease duration of more than 10 years since diagnosis
• Pregnant or nursing(lactating) women
• Women of child-bearing potential unless they are using highly effective
forms of contraception during dosing and for at least 6 months after
stopping study medication
• Subjects with active chronic disease of the immune system other than
MS or with immunodeficiency syndrome
• Subjects with active systemic bacterial, fungal or viral infections (such
as hepatitis, HIV, COVID-19), or known to have Acquired
Immunodeficiency Syndrome (AIDS)
• Subjects with neurological symptoms consistent with Progressive
Multifocal Leukoencephalopathy (PML) or with confirmed PML
• Subjects at risk of developing or having reactivation of syphilis or
tuberculosis (e.g. subjects with known exposure to, or history of
syphilis, or active or latent tuberculosis, even if previously treated), as
confirmed by medical history or per local practice
• Subjects with active hepatitis B and C disease, assessed locally
• Have received any live or live-attenuated vaccines within 4 weeks prior
to first study drug administration
• Have been treated with medications as specified or within timeframes
specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, daclizumab, cyclophosphamide,
teriflunomide etc.)
• Subjects suspected of not being able or willing to cooperate or comply
with study protocol requirements in the opinion of the investigator
Please see protocol for complete detailed list of exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered<br>every 4 weeks in subjects with relapsing forms of MS who had<br>breakthrough disease on fumarates or fingolimod;Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4<br>weeks in subjects with relapsing forms of MS who had breakthrough<br>disease on fumarates or fingolimod;Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks;Timepoint(s) of evaluation of this end point: 96 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Proportion of subjects with adverse events, including injection related reactions<br>• Proportion of patients with laboratory or vital signs results meeting abnormal criteria<br>• The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons;Timepoint(s) of evaluation of this end point: 96 weeks