An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224590

Enrollment

2010

Registered

2019-03-13

Start date

2019-04-09

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Relapsing Multiple Sclerosis

Interventions

Ofatumumab 20 mg sc injections once every 4 (q4) weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria: - Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject - Subjects with neurological findings consistent with PML or confirmed PML - Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS) - Subjects taking medications prohibited by the protocol - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Evaluate the long-term safety and tolerability of ofatumumab 20 mg subcutaneous(sc) once every 4 (q4) weeks in subjects with RMS from the first dose of ofatumumab	—

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Slovakia(Slovak Republic), South Africa, Spain, United Kingdom, United States

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026