CompletedRelapsing MSNCT05304520

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Natalizumab

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

What it measured

Main measures

  • Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6

    Month 6

    Safety
  • Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12

    Month 12

    Safety

Other measures (5)

  • Number of Participants Positive for Anti-Natalizumab-Antibody

    Baseline, Month 6 and 12

  • Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody

    Baseline, Month 6 and 12

  • Annual Relapse Rate

    Baseline, Months 3, 6, 9, and 12

    Relapses
  • Time to Relapse

    Baseline, Months 3, 6, 9, and 12

    Relapses
  • Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab

    Baseline, Months 3, 6, 9, and 12

    Disability progression

Who could take part

Relapsing MS · 18 and over

Key Inclusion Criteria: * Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC) * In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC Key Exclusion Criteria: * Progressive forms of MS * Contraindication to natalizumab treatment according to natalizumab SmPC * Concomitant treatment with other drugs for treating RRMS * Participation in any interventional clinical trial 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 collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

Papers

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Related trials

History

    1. Started

      Oct 2021

    2. Main results due

      Apr 2024

    3. Finished

      Apr 2024

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