At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 34 enrolled
Drug / intervention
Ofatumumabdrug
Likely dose
Ofatumumab 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)
In Brief
A Phase 4 clinical trial evaluating Ofatumumab for Relapsing Multiple Sclerosis. Completed, enrolled 34 participants across 6 sites.
Detailed Summary
This study aimed to understand whether patients with relapsing multiple sclerosis (RMS) can mount an immune response to SARS-CoV-2 mRNA vaccines (initial vaccinations or booster vaccines) when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
20222023202420252026
First PostedMay 2021
Enrollment StartMay 2021
Primary CompletionMay 2022
Study CompletionJun 2023
TodayJul 2026
First PostedMay 3, 2021
Enrollment StartMay 27, 2021
Primary CompletionMay 10, 2022
Study CompletionJun 13, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.2 years ago
Interventions
Ofatumumabdrug
Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter