Running, not recruitingRelapsing MSNCT05925049

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Natalizumab

    Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor

What it measured

Main measures

  • 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

Other measures (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

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

    Up to 1.75 years

    Relapses

Who could take part

Relapsing MS · 18 to 64

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jun 2023

      2. Main results due

        Oct 2026

      3. Finished

        Oct 2026

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