An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS T… (NCT04353492) | Clinical Trial Compass
CompletedPhase 3
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
United States562 participantsStarted 2020-07-14
Plain-language summary
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Diagnosis of MS according to the 2017 Revised McDonald criteria
* Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)
* 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
Exclusion Criteria:
* Subjects with primary progressive MS or SPMS without disease activity
* Subjects meeting criteria for neuromyelitis optica
* 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 medica…