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NCT Number: 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)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Cambridge, Massachusetts, 02142, United States

About this study

The study will collect data prospectively and retrospectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

Administered as specified in the treatment arm.

Other names: Tysabri

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)

    Time frame: Up to 1.75 years

Secondary outcomes

  1. Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)

    Time frame: Up to 1.75 years

  2. Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status

    Time frame: 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.

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

    Time frame: Up to 1.75 years

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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