Clinical trial NCT00493298: Tysabri Observational Program
Official title: TOP: TYSABRI Observational Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: disease progression
Multiple Sclerosis
disease activity
Tysabri
natalizumab
long-term safety
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-06-28
Enrollment: 6620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with RRMS who are therapy-naïve to Tysabri and who meet the criteria defined in the indication statement for prescription in the respective country.

Brief summary: 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.

Detailed description: TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Serious Adverse Events (SAE)
timeFrame: Up to 15 years
Secondary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Yearly for up to 15 years
measure: Distribution of the Total Number of Relapses
timeFrame: Yearly for up to 15 years
measure: Time to First Relapse
timeFrame: Yearly for up to 15 years
measure: Percentage of Participants with Relapse
timeFrame: Yearly for up to 15 years
measure: Percentage of Participants with Disability Progression
timeFrame: Yearly for up to 15 years
measure: Percentage of Participants that reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability
timeFrame: Yearly for up to 15 years
measure: Percentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months
timeFrame: Yearly for up to 15 years
measure: Evaluation of Baseline Disease Characteristics as Prognostic Indicators for Disease Activity and Disability Progression Over Time
timeFrame: Yearly for up to 15 years
measure: Evaluation of Short-Term (1 year) Disease Outcomes as Prognostic Indicators for Disease Activity and Disability Progression Over Time
timeFrame: Yearly for up to 15 years
Other outcomes:
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country: Netherlands
facility: Research site
city: Zwolle
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research site
city: Bodo
country: Norway
facility: Research site
city: Drammen
country: Norway
facility: Research site
city: Forde
country: Norway
facility: Research site
city: Fredrikstad
country: Norway
facility: Research Site
city: Haugesund
country: Norway
facility: Research site
city: Lillehammer
country: Norway
facility: Research site
city: Lørenskog
country: Norway
facility: Research site
city: Molde
country: Norway
facility: Research site
city: Namsos
country: Norway
facility: Research site
city: Oslo
country: Norway
facility: Research site
city: Oslo
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research site
city: Tromso
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research site
city: Tønsberg
country: Norway
facility: Research site
city: Aveiro
country: Portugal
facility: Research site
city: Beja
country: Portugal
facility: Research site
city: Evora
country: Portugal
facility: Research site
city: Funchal
country: Portugal
facility: Research site
city: Lisboa
country: Portugal
facility: Research site
city: Lisboa
country: Portugal
facility: Research site
city: Porto
country: Portugal
facility: Research site
city: Setubal
country: Portugal
facility: Research site
city: Banská Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research site
city: Kosice
country: Slovakia
facility: Research site
city: Nitra
country: Slovakia
facility: Research site
city: Avila
country: Spain
facility: Research site
city: Badalona
country: Spain
facility: Research site
city: Barcelona
country: Spain
facility: Research site
city: Barcelona
country: Spain
facility: Research site
city: Girona
country: Spain
facility: Research site
city: Langreo
country: Spain
facility: Research site
city: Logroño
country: Spain
facility: Research site
city: Palma de Mallorca
country: Spain
facility: Research site
city: Ponferrada
country: Spain
facility: Research site
city: San Sebastian
country: Spain
facility: Research site
city: Tarragona
country: Spain
facility: Research site
city: Tarragona
country: Spain
facility: Research site
city: Vitoria
country: Spain
facility: Research site
city: Edgbaston
country: United Kingdom
facility: Research site
state: Birmingham
city: Canterbury
country: United Kingdom
facility: Research site
state: Kent
city: Hammersmith
country: United Kingdom
facility: Research site
state: London
city: Salford
country: United Kingdom
facility: Research site
state: Manchester
city: Belfast
country: United Kingdom
facility: Research site
city: Brighton
country: United Kingdom
facility: Research site
city: Bristol
country: United Kingdom
facility: Research site
city: Coventry
country: United Kingdom
facility: Research site
city: Exeter
country: United Kingdom
facility: Research site
city: Liverpool
country: United Kingdom
facility: Research site
city: Middlesborough
country: United Kingdom
facility: Research site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research site
city: Nottingham
country: United Kingdom
facility: Research site
city: Stoke on Trent
country: United Kingdom
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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. eCollection 2021.
citation: 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-2019-322326. Epub 2020 Mar 31.
citation: 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.