An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to Ofatumumab

A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

LBCTR

Registry ID

LBCTR2021034775

Enrollment

Registered

2025-02-11

Start date

2021-08-10

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Relapsing Multiple Sclerosis MS

Interventions

Biological: Ofatumumab Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml c

Informed Consent form , IMP administration , Visit assessment and schedule

ICF, IMP

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Diagnosis of multiple sclerosis (MS) Relapsing MS (RRMS or SPMS) course Subject transitioning from either fingolimod or dimethyl fumarate, following min 6 months treatment with either drug Breakthrough disease as evidence by clinical relapses or MRI EDSS score of 0 to 4

Exclusion criteria

Exclusion criteria: Primary progressive MS or SPMS without disease activity Disease duration of more than 10 years since diagnosis Patients with an active chronic disease of the immune system other than MS Patients at risk of developing or having reactivation of hepatitis Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Name: Annual Relapse Rate;Timepoints: 96 weeks;Measure: number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient	—

Secondary

Measure	Time frame
Name: Safety evaluation;Timepoints: 96 weeks;Measure: Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs as well as proportion of patients discontinuing treatment due to insufficient effectiveness or safety	—

Countries

Australia, Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Lebanon, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Switzerland, Turkey, United States of America

Contacts

Public ContactTaghrid El Hajj

Rafik Hariri University Hospital

taghridelhajj@gmail.com9613494008

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026