An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate 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-NO
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
• 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)
• Subject transitioning from either dimethyl fumarate 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 dimethyl fumarate 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
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 550
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
• Subjects at risk of developing or having reactivation of hepatitis:
positive results at screening for serological markers for hepatitis A, B, C
and E indicating acute or chronic infection
• 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
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 every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate or fingolimod;Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4 weeks in subjects with relapsing forms of MS who had breakthrough disease on dimethyl fumarate 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