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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Natalizumab

Detailed Description

The study will collect data prospectively and retrospectively.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include available EU MS registry participants.

Description

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/Exclusion criteria may apply.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Naive Participants; Per standard of care, participants with MS enrolled in selected MS registries, who are natalizumab-naïve and other MS mAb-therapy-naive will receive natalizumab 300 mg, SC injection according to decision of the treating physician.	Drug: Natalizumab; Administered as specified in the treatment arm.; Other Names: Tysabri
Cohort 2: Natalizumab Experienced; Per standard of care, participants with MS enrolled in selected MS registries, who have previously received natalizumab IV will be switched from natalizumab IV to SC administration to receive natalizumab 300 mg, SC injection according to decision of the treating physician.	Drug: Natalizumab; Administered as specified in the treatment arm.; Other Names: Tysabri

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Up to 1.75 years
Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status		Up to 1.75 years

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Natalizumab
• Other Study ID Numbers: 101MS412; EUPAS48753 (Other Identifier: EU PAS register number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No