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)

NCT05925049 | Active Not Recruiting FDA Drug

• 2 other identifiers: 101MS412EUPAS48753
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status

  Up to 1.75 years

Study Arms (2)

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

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

Interventions

Natalizumab DRUG

Administered as specified in the treatment arm.

Also known as: Tysabri

Cohort 1: Naive Participants; Cohort 2: Natalizumab Experienced

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include available EU MS registry participants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: June 30, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)