CompletedRelapsing MSNCT00493298

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 with Serious Adverse Events (SAE)

    Up to 15 years

    Safety

Other measures (9)

  • Annualized Relapse Rate (ARR)

    Yearly for up to 15 years

    Relapses
  • Distribution of the Total Number of Relapses

    Yearly for up to 15 years

    Relapses
  • Time to First Relapse

    Yearly for up to 15 years

    Relapses
  • Percentage of Participants with Relapse

    Yearly for up to 15 years

    Relapses
  • Percentage of Participants with Disability Progression

    Yearly for up to 15 years

    Disability progression
  • Percentage of Participants that reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability

    Yearly for up to 15 years

    Disability progression
  • Percentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months

    Yearly for up to 15 years

    Disability progression
  • Evaluation of Baseline Disease Characteristics as Prognostic Indicators for Disease Activity and Disability Progression Over Time

    Yearly for up to 15 years

    Disability progressionRelapses
  • Evaluation of Short-Term (1 year) Disease Outcomes as Prognostic Indicators for Disease Activity and Disability Progression Over Time

    Yearly for up to 15 years

    Disability progressionRelapses

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Documented diagnosis of Relapsing Remitting Multiple Sclerosis * The decision to treat with Tysabri must precede enrollment * Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment * Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri Key Exclusion Criteria: * History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections * History of positive anti-Tysabri antibodies * Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri * Patient immunocompromised at the time of enrollment * Known active malignancy * Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile) 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 assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

Papers

Loading reviews and guidelines…

Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Jun 2007

    2. Main results due

      Nov 2023

    3. Finished

      Nov 2023

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error