NCT05925049

A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)

An Observational Study Utilising Data From EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.

Detailed description

The study will collect data prospectively and retrospectively.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Natalizumab	Administered as specified in the treatment arm.

Timeline

• Start date: 2023-06-30
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-06-29
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study