TOP
What it found
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
RelapsesDistribution of the Total Number of Relapses
Yearly for up to 15 years
RelapsesTime to First Relapse
Yearly for up to 15 years
RelapsesPercentage of Participants with Relapse
Yearly for up to 15 years
RelapsesPercentage of Participants with Disability Progression
Yearly for up to 15 years
Disability progressionPercentage of Participants that reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability
Yearly for up to 15 years
Disability progressionPercentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months
Yearly for up to 15 years
Disability progressionEvaluation of Baseline Disease Characteristics as Prognostic Indicators for Disease Activity and Disability Progression Over Time
Yearly for up to 15 years
Disability progressionRelapsesEvaluation 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
Results
Epoch Analysis of On-Treatment Disability Progression Events over Time in the Tysabri Observational Program (TOP).PLoS One · 2016
Results
Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Greco A, Sun Z, Lasky T; TOP Investigators. Tysabri Observational Program (TOP): long-term safety and effectiveness of natalizumab treatment in relapsing-remitting multiple sclerosis over 15 years. J Neurol Neurosurg Psychiatry. 2026 Jun 12;97(7):591-599. doi: 10.1136/jnnp-2025-337367.Results
Butzkueven H, Kappos L, Spelman T, Trojano M, Wiendl H, Su R, Liao S, Hyde R, Licata S, Ho PR, Campbell N. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord. 2021 Sep 27;14:17562864211042458. doi: 10.1177/17562864211042458.Results
Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho PR, Licata S; Tysabri Observational Program (TOP) Investigators. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):660-668. doi: 10.1136/jnnp-2019Results
Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1190-7. doi: 10.1136/jnnp-2013-306936. Epub 2014 Feb 14.
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Linked trials
Referred to by
Safety and Efficacy in Pediatric MS Patients Prescribed T…Completed
Links found where a registry record names another trial's registry number.
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History
Started
Jun 2007
Main results due
Nov 2023
Finished
Nov 2023
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