Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China (NCT05199571) | Clinical Trial Compass
CompletedPhase 4
Study of Efficacy and Safety of Ofatumumab in Relapsing Multiple Sclerosis (RMS) Patients in China
China99 participantsStarted 2022-07-22
Plain-language summary
The purpose of this study was to evaluate the efficacy and safety of ofatumumab s.c. in adult participants with relapsing multiple sclerosis (RMS) in China.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female Chinese aged 18-55 years (inclusive) at their enrollment of the study (signing the study consent form).
* Clinical definite diagnosis of RMS according to the 2017 Revised McDonald criteria (Thompson et al 2018, and the documentation prior to their enrollment to the study (signing the study consent form) of:
* Two documented relapses during the past 2 years, or
* One documented relapse during the last year, or
* A positive Gd-enhancing MRI scan during the year prior to Screening. Note: Screening MRI scan may be used if no positive Gd-enhancing scan exists from prior year.
* Disability status with an EDSS score of 0 - 5.5 (inclusive) at Screening.
* Neurologically stable within 1 month prior to both Screening and Baseline (including no MS relapse in this period).
Exclusion Criteria:
* Participants with primary progressive MS (PPMS) or secondary progressive MS (SPMS) without disease activity
* Participants meeting criteria for neuromyelitis optica spectrum disorder (NMOSD)
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless using effective methods of contraception while taking study treatment and for at least 6 months after stopping medication
* Participants with an active chronic disease of the immune system other than MS
* Participants with neurological findings consistent with PML or confirmed PML
* Participants with active hepatitis B disease
* Participants with active systemic infections (including…
What they're measuring
1
Adjusted Annualized Relapse Rate (ARR) Based on Confirmed Relapses