Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked… (NCT05084638) | Clinical Trial Compass
CompletedPhase 4
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
United States180 participantsStarted 2022-01-25
Plain-language summary
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study also assesses changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
Who can participate
Age range18 Years – 35 Years
SexALL
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Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study
✓. Age 18-35 years
✓. Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device
✓. Able to provide blood sample (no CSF will be collected in HC)
✓. Diagnosis of RRMS per McDonald Criteria (2010/2017)
✓. Within 6 months of diagnosis of clinically definite MS (CDMS)
✓. EDSS 0-3.0 (Inclusive)
✓. Treatment-naïve to MS DMT
Exclusion criteria
✕. Confounding medical condition as determined by the investigator
✕. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
✕
What they're measuring
1
Percentage of Participants Achieving NEDA-3 (No Evidence of Disease Activity-3)