Relapsing-Remitting Multiple Sclerosis Clinical Trial
— TOPOfficial title:
TOP: TYSABRI Observational Program
| 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 |
| Verified date | April 2024 |
| Source | Biogen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| 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 | |
| France | Research site | Auxerre Cedex | |
| France | Research site | Avranches Cedex | |
| France | Research site | Bayonne Cedex | |
| France | Research site | Beauvais Cedex | |
| France | Research site | Belfort Cedex | |
| France | Research site | Bethune Cedex | |
| France | Research site | Beuvry | |
| France | Research site | Boulogne sur mer cedex | |
| France | Research site | Calais Cedex | |
| France | Research site | Castelnau Le Lez Cedex | |
| France | Research site | Castres Cedex | |
| France | Research site | Chambery Cedex | |
| France | Research site | Chambery cedex | |
| France | Research site | Colmar Cedex | |
| France | Research site | Compiegne Cedex | |
| France | Research site | Dieppe | |
| France | Research site | Dreux Cedex | |
| France | Research site | Dunkerque cedex 1 | |
| France | Research site | Epinal cedex | |
| France | Research site | Évreux | |
| France | Research site | Haguenau cedex | |
| France | Research site | La Rochelle Cedex 1 | |
| France | Research site | Le Chesnay Cedex | |
| France | Research site 177, rue de Versailles- Dr Servan | Le Chesnay Cedex | |
| France | Research site | Le Coudray | |
| France | Research site | Le Havre | |
| France | Research site | Le Mans | |
| France | Research site | Lille | |
| France | Research site | Lisieux Cedex | |
| France | Research site | Lomme Cedex | |
| France | Research site | Mantes La Jolie Cedex | |
| France | Research site | Maubeuge Cedex | |
| France | Research site | Metz Cedex 01 | |
| France | Research site | Metz Tessy | |
| France | Research site | Mont De Marsan Cedex | |
| France | Research site | Montauban Cedex | |
| France | Research site | Montlucon | |
| France | Research site | Montpellier | |
| France | Research site | Montpellier | |
| France | Research site | Mulhouse Cedex | |
| France | Research site | Nice Cedex 2 | |
| France | Research site | Paris | |
| France | Research site | Paris cedex 14 | |
| France | Research site | PAU | |
| France | Research site | Pau Cedex | |
| France | Research site | Quimper Cedex | |
| France | Research site | Reims | |
| France | Research site | Sarreguemines | |
| France | Research site | Saumur Cedex | |
| France | Research site | St Aubin Sur Scie | |
| France | Research site | St Malo Cedex | |
| France | Research site | Talant | |
| France | Research site | Tarbes | |
| France | Research site | Tarbes Cedex 9 | |
| France | Research site | Tourcoing Cedex | |
| France | Research site | Trappes | |
| France | Research site | Trelaze | |
| France | Research site | Trélazé | |
| France | Research site | Valenciennes Cedex | |
| France | Research site | Vesoul Cedex | |
| France | Research site | Vichy cedex | |
| Germany | Research site | Abensberg | |
| Germany | Research site | Andernach | |
| Germany | Research Site | Arnsdorf | |
| Germany | Research site | Asperg | |
| Germany | Research site | Augsburg | |
| Germany | Research site | Bad Hersfeld | |
| Germany | Research site | Bad Honnef | |
| Germany | Research Site | Bad Kissingen | |
| Germany | Research site | Bad Mergentheim | |
| Germany | Research site | Bad Reichenhall | |
| Germany | Research site | Bamberg | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin | |
| Germany | Research site | Berlin-Tegel | |
| Germany | Research site | Bielefeld | |
| Germany | Research site | Bielefeld | |
| Germany | Research site | Bochum | |
| Germany | Research site | Bogen | |
| Germany | Research site | Bonn | |
| Germany | Research site | Bruchsal | |
| Germany | Research site | Buchholz | |
| Germany | Research site | Celle | |
| Germany | Research site | Chemnitz | |
| Germany | Research site | Dillingen | |
| Germany | Research site | Dresden | |
| Germany | Research site | Duisburg | |
| Germany | Research site | Düren | |
| Germany | Research site | Düsseldorf | |
| Germany | Research site | Düsseldorf | |
| Germany | Research site | Eisenach | |
| Germany | Research site | Emden | |
| Germany | Research site | Emmendingen | |
| Germany | Research site | Erbach | |
| Germany | Research site | Erlangen | |
| Germany | Research site | Essen | |
| Germany | Research site | Essen | |
| Germany | Research site | Essen | |
| Germany | Research site | Falkenstein | |
| Germany | Research site | Frankfurt | |
| Germany | Research site | Freiburg | |
| Germany | Research site | Görlitz | |
| Germany | Research site | Göttingen | |
| Germany | Research site | Greifswald | |
| Germany | Research site | Halle | |
| Germany | Research site | Hamburg | |
| Germany | Research site | Hamburg | |
| Germany | Research site | Hamburg | |
| Germany | Research site | Heidelberg | |
| Germany | Research site | Herford | |
| Germany | Research site | Itzehoe | |
| Germany | Research site | Jena | |
| Germany | Research site | Kaiserslautern | |
| Germany | Research site | Kaltenkirchen | |
| Germany | Research site | Kandel | |
| Germany | Research site | Kassel | |
| Germany | Research site | Kastellaun | |
| Germany | Research site | Kirchberg | |
| Germany | Research site | Kirchheim unter Teck | |
| Germany | Research site | Köln | |
| Germany | Research site | Köln | |
| Germany | Research Site | Kreuzau | |
| Germany | Research site | Ladenburg | |
| Germany | Research site | Leipzig | |
| Germany | Research site | Leipzig | |
| Germany | Research site | Lengerich | |
| Germany | Research site | Lüdenscheid | |
| Germany | Research site | Lüdenscheid | |
| Germany | Research site | Ludwigshafen | |
| Germany | Research site | Lüneburg | |
| Germany | Research site | Magdeburg | |
| Germany | Research site | Mannheim | |
| Germany | Research site | Mannheim | |
| Germany | Research site | Marburg | |
| Germany | Research site | München | |
| Germany | Research site | München | |
| Germany | Research site | München | |
| Germany | Research site | München | |
| Germany | Research site | München | |
| Germany | Research site | Münster | |
| Germany | Research site | Neuburg | |
| Germany | Research site | Neukirchen-Vluyn | |
| Germany | Research site | Neuruppin | |
| Germany | Research site | Nürnberg | |
| Germany | Research site | Nürnberg | |
| Germany | Research site | Nürnberg | |
| Germany | Research site | Oldenburg | |
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| Germany | Research site | Osnabrück | |
| Germany | Research site | Paderborn | |
| Germany | Research site | Potsdam | |
| Germany | Research site | Regensburg | |
| Germany | Research site | Remscheid | |
| Germany | Research site | Rüdersdorf | |
| Germany | Research Site | Rülzheim | |
| Germany | Research site | Schlüchtern | |
| Germany | Research site | Schorndorf | |
| Germany | Research site | Schwaebisch | |
| Germany | Research site | Siegen | |
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| Germany | Research site | Stuttgart | |
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| Germany | Research site | Teupitz | |
| Germany | Research site | Trier | |
| Germany | Research site | Troisdorf | |
| Germany | Research site | Ulm | |
| Germany | Research site | Ulm | |
| Germany | Research site | Ulm | |
| Germany | Research site | Unterhaching | |
| Germany | Research site | Wasserburg | |
| Germany | Research site | Weimar | |
| Germany | Research site | Weinheim | |
| Germany | Research site | Wermsdorf | |
| Germany | Research site | Wernigerode | |
| Germany | Research site | Wiesbaden | |
| Germany | Research site | Wolfenbüttel | |
| Germany | Research site | Wolfratshausen | |
| Germany | Research site | Würzburg | |
| Germany | Research site | Zwickau | |
| Greece | Research Site | Alexandroupoli | |
| Greece | Research site | Athens | |
| Greece | Research site | Athens | |
| Greece | Research site | Athens | |
| Greece | Research site | Athens | |
| Greece | Research site | Athens | |
| Greece | Research site | Heraklion | Crete |
| Greece | Research site | Ioannina | |
| Greece | Research site | Patras | |
| Greece | Research site | Patras | |
| Greece | Research site | Thessaloniki | |
| Greece | Research site | Thessaloniki | |
| Greece | Research site | Thessaloniki | |
| Italy | Research site | Bari | |
| Italy | Research site | Bergamo | |
| Italy | Research site | Cagliari | |
| Italy | Research site | Cefalù | |
| Italy | Research site | Chieti | |
| Italy | Research site | Cuneo | |
| Italy | Research site | Fidenza | |
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| Italy | Research site | Foggia | |
| Italy | Research site | Gallarate | |
| Italy | Research site | Milano | |
| Italy | Research site | Milano | |
| Italy | Research site | Napoli | |
| Italy | Research site | Orbassano | |
| Italy | Research site | Roma | |
| Italy | Research site | Roma | |
| Italy | Research site | Roma | |
| Mexico | Research site | Aguascalientes | |
| Mexico | Research site | Estado de México | |
| Mexico | Research Site | Leon | |
| Mexico | Research site | Mexico City | |
| Mexico | Research site | Mexico City | |
| Mexico | Research site | Mexico City | |
| Mexico | Research site | Mexico City | |
| Mexico | Research site | Mexico City | |
| Mexico | Research Site | Mexico city | |
| Mexico | Research site | Monterrey | Nuevo León |
| Mexico | Research site | Monterrey | Nuevo León |
| Mexico | Research site | Puebla | |
| Mexico | Research Site | Puebla | |
| Mexico | Research Site | San Luis Potosi | |
| Mexico | Research site | Zapopan | Jalisco |
| Netherlands | Research Site | Almelo | |
| Netherlands | Research site | Blaricum | |
| Netherlands | Research site | Breda | |
| Netherlands | Research site | Den Haag | |
| Netherlands | Research site | Eindhoven | |
| Netherlands | Research site | Geldrop | |
| Netherlands | Research site | Gouda | |
| Netherlands | Research site | Heerenveen | |
| Netherlands | Research site | Heerlen | |
| Netherlands | Research site | Helmond | |
| Netherlands | Research site | Hengelo | |
| Netherlands | Research site | Hoorn | |
| Netherlands | Research site | Leeuwarden | |
| Netherlands | Research Site | Meppel | |
| Netherlands | Research site | Nieuwegein | |
| Netherlands | Research site | Nijmegen | |
| 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 | |
| Spain | Research site | Barcelona | |
| Spain | Research site | Girona | |
| Spain | Research site | Langreo | |
| Spain | Research site | Logroño | |
| Spain | Research site | Palma de Mallorca | |
| Spain | Research site | Ponferrada | |
| Spain | Research site | San Sebastian | |
| Spain | Research site | Tarragona | |
| Spain | Research site | Tarragona | |
| Spain | Research site | Vitoria | |
| United Kingdom | Research site | Belfast | |
| United Kingdom | Research site | Brighton | |
| United Kingdom | Research site | Bristol | |
| United Kingdom | Research site | Canterbury | Kent |
| United Kingdom | Research site | Coventry | |
| United Kingdom | Research site | Edgbaston | Birmingham |
| United Kingdom | Research site | Exeter | |
| United Kingdom | Research site | Hammersmith | London |
| United Kingdom | Research site | Liverpool | |
| United Kingdom | Research site | Middlesborough | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Biogen |
Argentina, Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Portugal, Slovakia, Spain, United Kingdom,
| 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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