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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00493298
Other study ID # IMA-06-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2007
Est. completion date November 1, 2023

Study information

Verified date April 2024
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6620
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tysabri
According to the local prescribing information

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Buenos Aires
Argentina Research Site Buenos Aires
Argentina Research Site Buenos Aires
Argentina Research Site Caba
Argentina Research Site Cordoba
Argentina Research site Santa Fe
Australia Research site Adelaide South Australia
Australia Research Site Auchenflower Queensland
Australia Research site Box Hill Victoria
Australia Research site Camperdown New South Wales
Australia Research site Fitzroy Victoria
Australia Research site Gold Coast Queensland
Australia Research site Heidelberg Victoria
Australia Research site Liverpool New South Wales
Australia Research Site Melbourne Victoria
Australia Research site Nedlands Western Australia
Australia Research site New Lambton Heights New South Wales
Australia Research Site North Adelaide South Australia
Australia Research site Parkville Victoria
Australia Research Site St. Leonards New South Wales
Belgium Research site Aalst
Belgium Research site Antwerpen
Belgium Research site Bocholt
Belgium Research site Brasschaat
Belgium Research site Brugge
Belgium Research site Brussel
Belgium Research site Brussel
Belgium Research site Brussel (Jette)
Belgium Research site Bruxelles (Anderlecht)
Belgium Research site Charleroi
Belgium Research Site Charleroi
Belgium Research site Edegem
Belgium Research site Fraiture
Belgium Research site Genk
Belgium Research site Gent
Belgium Research site Hasselt
Belgium Research site Kortrijk
Belgium Research site La Louviere
Belgium Research site Leuven
Belgium Research site Libramont
Belgium Research site Liège
Belgium Research site Malmedy
Belgium Research site Melsbroek
Belgium Research site Oostende
Belgium Research site Ottignies
Belgium Research Site Overpelt
Belgium Research site Sijsele
Belgium Research site Tournai
Belgium Research site Wilrijk
Belgium Research site Woluwe-Saint-Lambert
Brazil Research Site Belo Horizonte
Brazil Research Site Botucatu
Brazil Research Site Rio de Janeiro
Brazil Research Site Sao Paulo
Brazil Research Site Sao Paulo
Canada Research site Bracebridge Ontario
Canada Research site Burnaby British Columbia
Canada Research site Edmonton Alberta
Canada Research site Gatineau Quebec
Canada Research site Greenfield Park Quebec
Canada Research site Guelph Ontario
Canada Research site Halifax Nova Scotia
Canada Research site Hamilton Ontario
Canada Research site Hamilton Ontario
Canada Research site London Ontario
Canada Research site Milton Ontario
Canada Research site Montreal Quebec
Canada Research site Montréal Quebec
Canada Research site Regina Saskatchewan
Canada Research site Saint John New Brunswick
Canada Research site Thunder Bay Ontario
Canada Research site Toronto Ontario
Canada Research Site Vancouver British Columbia
Canada Research site Winnipeg Manitoba
Czechia Research site Brno
Czechia Research site Brno
Czechia Research site Ceské Budejovice
Czechia Research site Hradec Kralové
Czechia Research site Jihlava
Czechia Research site Olomouc
Czechia Research site Ostrava
Czechia Research site Pardubice
Czechia Research site Plzen
Czechia Research site Prague
Czechia Research site Prague 10
Czechia Research site Prague 4
Czechia Research site Praha 5
Czechia Research site Teplice
Czechia Research Site Teplice
Czechia Research site Zlín
Finland Research site Helsinki
Finland Research site Jyväskylä
Finland Research site Kuopio
Finland Research site Pori
Finland Research site Seinäjoki
Finland Research site Tampere
Finland Research site Turku
France Research site Agen Cedex 9
France Research site Aix En Provence Cedex 1
France Research site Alencon Cedex
France Research site Angouleme
France Research site ,1 Allée du Château- Dr Wagner Ars-Laquenexy
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France Research site Dunkerque cedex 1
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France Research site La Rochelle Cedex 1
France Research site Le Chesnay Cedex
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France Research site Le Mans
France Research site Lille
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France Research site Lomme Cedex
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France Research site Maubeuge Cedex
France Research site Metz Cedex 01
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France Research site Mulhouse Cedex
France Research site Nice Cedex 2
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Greece Research Site Alexandroupoli
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Netherlands Research Site Almelo
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Netherlands Research site Leeuwarden
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Netherlands Research site Roermond
Netherlands Research site Rotterdam
Netherlands Research site s Hertogenbosch
Netherlands Research site Sittard-Geleen
Netherlands Research site Tilburg
Netherlands Research site Venray
Netherlands Research site Woerden
Netherlands Research Site Zwolle
Norway Research site Bergen
Norway Research site Bodo
Norway Research site Drammen
Norway Research site Forde
Norway Research Site Fredrikstad
Norway Research site Haugesund
Norway Research site Lillehammer
Norway Research site Lørenskog
Norway Research site Molde
Norway Research site Namsos
Norway Research site Oslo
Norway Research Site Oslo
Norway Research Site Skien
Norway Research site Stavanger
Norway Research site Tønsberg
Norway Research Site Tromso
Norway Research site Trondheim
Portugal Research site Aveiro
Portugal Research site Beja
Portugal Research site Evora
Portugal Research site Funchal
Portugal Research site Lisboa
Portugal Research site Lisboa
Portugal Research site Porto
Portugal Research site Setubal
Slovakia Research Site Banská Bystrica
Slovakia Research Site Bratislava
Slovakia Research Site Bratislava
Slovakia Research site Bratislava
Slovakia Research site Kosice
Slovakia Research site Nitra
Spain Research site Avila
Spain Research site Badalona
Spain Research site Barcelona
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Spain Research site Logroño
Spain Research site Palma de Mallorca
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Spain Research site San Sebastian
Spain Research site Tarragona
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Spain Research site Vitoria
United Kingdom Research site Belfast
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United Kingdom Research site Coventry
United Kingdom Research site Edgbaston Birmingham
United Kingdom Research site Exeter
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United Kingdom Research site Newcastle Upon Tyne
United Kingdom Research site Nottingham
United Kingdom Research site Salford Manchester
United Kingdom Research site Stoke on Trent

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Finland,  France,  Germany,  Greece,  Italy,  Mexico,  Netherlands,  Norway,  Portugal,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Serious Adverse Events (SAE) Up to 15 years
Secondary Annualized Relapse Rate (ARR) A clinical relapse is defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement. New or recurrent neurological symptoms that occur less than 30 days following the onset of a protocol-defined relapse should be considered part of the same relapse. Yearly for up to 15 years
Secondary Distribution of the Total Number of Relapses Yearly for up to 15 years
Secondary Time to First Relapse Yearly for up to 15 years
Secondary Percentage of Participants with Relapse Yearly for up to 15 years
Secondary Percentage of Participants with Disability Progression Disability progression is defined as at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from Baseline that is sustained over 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Yearly for up to 15 years
Secondary Percentage of Participants that reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability The percentage of participants that reach EDSS milestones such as 4.0, 6.0, and 7.0 sustained after 6 months. The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Yearly for up to 15 years
Secondary Percentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months Yearly for up to 15 years
Secondary Evaluation of Baseline Disease Characteristics as Prognostic Indicators for Disease Activity and Disability Progression Over Time Baseline disease characteristics evaluated will include: EDSS; Disease duration at baseline; Number of relapses during 1 and 2 years before baseline; Previous use of disease modifying therapy; Age, gender. Yearly for up to 15 years
Secondary Evaluation of Short-Term (1 year) Disease Outcomes as Prognostic Indicators for Disease Activity and Disability Progression Over Time Short term outcomes evaluated will include: EDSS progression during first 12 months; Occurrence of relapses during first 12 months Yearly for up to 15 years
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Completed NCT01416155 - Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis Phase 2
Completed NCT01244139 - Safety Study of BIIB033 in Subjects With Multiple Sclerosis Phase 1
Completed NCT00559702 - Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Phase 1
Completed NCT00493116 - Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta Phase 4
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