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Analysis of MS Patients Who Have Had Greater Than 60 Infusions of Natalizumab

Analysis of Multiple Sclerosis Patients Who Have Had Greater Than 60 Infusions of Natalizumab: Safety and Efficacy
Status unknownMS (type not specified)NCT04964700

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

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 reported cases of PML ( progressive multifocal leukoencephalopathy)

    While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)

  • Number of documented exacerbations

    While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)

    RelapsesQuality of life (reported by participants)

  • Change in EDSS Score

    One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

    Disability progression

  • Number of new MRI lesions

    While on Natalizumab (Dosing) to one year after natalizumab use (Termination Date)

    MRI lesions

Other measures (4)

  • Change in JCV Ab index value

    One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

  • Number of reported clinically significant changes on MRI that may indicate other opportunistic infections.

    One year prior to natalizumab use (Baseline), while on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

    MRI lesions

  • Number of clinically significant lab values as measured CMP ( Comprehensive Metabolic Panel)

    While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

    Walking and mobility

  • Number of clinically significant lab values as measured by the CBC (Complete Blood Count)

    While on Natalizumab (Dosing), to one year after natalizumab use (Termination Date)

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Multiple Sclerosis patients treated with long term use of natalizumab--60 or more infusions (5 years) Exclusion Criteria: * Patients who do not have 60 or more infusions (5 years) of Natalizumab.

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

About this trial

In the sponsor's words

The purpose of this study is to explore the safety and efficacy data in clinic patients who have been treated with Natalizumab for more than 60 continuous infusions.

Papers

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Related trials

History

    1. Started

      May 2021

    2. Main results due

      Apr 2022

    3. Finished

      Jun 2022

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