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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05925049

Enrollment

400

Registered

2023-06-29

Start date

2023-06-30

Completion date

2026-10-31

Last updated

2026-05-13

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

Conditions

Multiple Sclerosis

Brief 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.

Interventions

DRUGNatalizumab

Administered as specified in the treatment arm.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Participants who are natalizumab-naïve and other MS mAb-naive and who start on natalizumab SC. * Participants who have previously received natalizumab IV and switch from natalizumab IV to SC administration. Key

Exclusion criteria

: * For the natalizumab-naive and other MS mAb-naive cohort, participants who previously received natalizumab or other MS mAbs will be excluded. * For the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded. NOTE: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)	Up to 1.75 years

Secondary

Measure	Time frame	Description
Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)	Up to 1.75 years	—
Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status	Up to 1.75 years	SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product.
Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status	Up to 1.75 years	—

Countries

United States

Contacts

STUDY_DIRECTORMedical Director

Biogen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026