A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes (PRO) in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507493-41-00

Acronym

COMB157G23101

Enrollment

293

Registered

2024-07-08

Start date

2020-08-04

Completion date

2024-09-27

Last updated

2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsing multiple sclerosis (RMS)

Brief summary

Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks

Detailed description

Proportion of subjects with adverse events, including injection related reactions, Proportion of patients with laboratory or vital signs results meeting abnormal criteria, The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons

Interventions

DRUGKesimpta 20 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks	—

Secondary

Measure	Time frame
Proportion of subjects with adverse events, including injection related reactions, Proportion of patients with laboratory or vital signs results meeting abnormal criteria, The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons	—

Countries

Bulgaria, Germany, Latvia, Poland, Portugal, Slovakia, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026