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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00493298
Registration number
NCT00493298
Ethics application status
Date submitted
27/06/2007
Date registered
28/06/2007
Date last updated
8/04/2024
Titles & IDs
Public title
Tysabri Observational Program
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Scientific title
TOP: TYSABRI Observational Program
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Secondary ID [1]
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IMA-06-02
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Universal Trial Number (UTN)
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Trial acronym
TOP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Tysabri
Tysabri - According to the local prescribing information
Treatment: Drugs: Tysabri
According to the local prescribing information
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Serious Adverse Events (SAE)
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Assessment method [1]
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Timepoint [1]
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Up to 15 years
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Secondary outcome [1]
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Annualized Relapse Rate (ARR)
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Assessment method [1]
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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.
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Timepoint [1]
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Yearly for up to 15 years
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Secondary outcome [2]
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Distribution of the Total Number of Relapses
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Assessment method [2]
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0
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Timepoint [2]
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Yearly for up to 15 years
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Secondary outcome [3]
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0
Time to First Relapse
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Assessment method [3]
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0
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Timepoint [3]
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Yearly for up to 15 years
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Secondary outcome [4]
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Percentage of Participants with Relapse
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Assessment method [4]
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0
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Timepoint [4]
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Yearly for up to 15 years
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Secondary outcome [5]
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Percentage of Participants with Disability Progression
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Assessment method [5]
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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.
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Timepoint [5]
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Yearly for up to 15 years
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Secondary outcome [6]
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Percentage of Participants that reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability
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Assessment method [6]
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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.
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Timepoint [6]
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Yearly for up to 15 years
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Secondary outcome [7]
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Percentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months
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Assessment method [7]
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0
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Timepoint [7]
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Yearly for up to 15 years
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Secondary outcome [8]
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Evaluation of Baseline Disease Characteristics as Prognostic Indicators for Disease Activity and Disability Progression Over Time
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Assessment method [8]
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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.
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Timepoint [8]
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Yearly for up to 15 years
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Secondary outcome [9]
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Evaluation of Short-Term (1 year) Disease Outcomes as Prognostic Indicators for Disease Activity and Disability Progression Over Time
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Assessment method [9]
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Short term outcomes evaluated will include: EDSS progression during first 12 months; Occurrence of relapses during first 12 months
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Timepoint [9]
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Yearly for up to 15 years
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2023
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Sample size
Target
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Accrual to date
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Final
6620
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research site - Camperdown
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Research site - Liverpool
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Recruitment postcode(s) [1]
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2050 - Camperdown
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2170 - Liverpool
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2305 - New Lambton Heights
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2065 - St. Leonards
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4066 - Auchenflower
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9726 - Gold Coast
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5042 - Adelaide
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5006 - North Adelaide
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3128 - Box Hill
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3065 - Fitzroy
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3084 - Heidelberg
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3004 - Melbourne
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3050 - Parkville
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Recruitment postcode(s) [14]
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6009 - Nedlands
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Recruitment outside Australia
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Argentina
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Buenos Aires
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State/province [116]
0
0
Saumur Cedex
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
St Aubin Sur Scie
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
St Malo Cedex
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Talant
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Tarbes Cedex 9
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Tarbes
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Tourcoing Cedex
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Trappes
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Trelaze
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Trélazé
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Valenciennes Cedex
Query!
Country [127]
0
0
France
Query!
State/province [127]
0
0
Vesoul Cedex
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Vichy cedex
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Évreux
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Abensberg
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Andernach
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Arnsdorf
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Asperg
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Augsburg
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Bad Hersfeld
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Bad Honnef
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Bad Kissingen
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Bad Mergentheim
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Bad Reichenhall
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Bamberg
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Berlin-Tegel
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Berlin
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Bielefeld
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Bochum
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Bogen
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Bonn
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Bruchsal
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Buchholz
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Celle
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Chemnitz
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Dillingen
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Dresden
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Duisburg
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Düren
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Düsseldorf
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Eisenach
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Emden
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Emmendingen
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Erbach
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Erlangen
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Essen
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Falkenstein
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Frankfurt
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Freiburg
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Greifswald
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Görlitz
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Göttingen
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Halle
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Hamburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Heidelberg
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Herford
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Itzehoe
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Jena
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Kaiserslautern
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Kaltenkirchen
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Kandel
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Kassel
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Kastellaun
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Kirchberg
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Kirchheim unter Teck
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Kreuzau
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Köln
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Ladenburg
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Leipzig
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Lengerich
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Ludwigshafen
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Lüdenscheid
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Lüneburg
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Magdeburg
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Mannheim
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Marburg
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
München
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Münster
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Neuburg
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Neukirchen-Vluyn
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Neuruppin
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Nürnberg
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Oldenburg
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Olpe
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Osnabrück
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Paderborn
Query!
Country [202]
0
0
Germany
Query!
State/province [202]
0
0
Potsdam
Query!
Country [203]
0
0
Germany
Query!
State/province [203]
0
0
Regensburg
Query!
Country [204]
0
0
Germany
Query!
State/province [204]
0
0
Remscheid
Query!
Country [205]
0
0
Germany
Query!
State/province [205]
0
0
Rüdersdorf
Query!
Country [206]
0
0
Germany
Query!
State/province [206]
0
0
Rülzheim
Query!
Country [207]
0
0
Germany
Query!
State/province [207]
0
0
Schlüchtern
Query!
Country [208]
0
0
Germany
Query!
State/province [208]
0
0
Schorndorf
Query!
Country [209]
0
0
Germany
Query!
State/province [209]
0
0
Schwaebisch
Query!
Country [210]
0
0
Germany
Query!
State/province [210]
0
0
Siegen
Query!
Country [211]
0
0
Germany
Query!
State/province [211]
0
0
Sinsheim
Query!
Country [212]
0
0
Germany
Query!
State/province [212]
0
0
Stade
Query!
Country [213]
0
0
Germany
Query!
State/province [213]
0
0
Stadtroda
Query!
Country [214]
0
0
Germany
Query!
State/province [214]
0
0
Stuttgart
Query!
Country [215]
0
0
Germany
Query!
State/province [215]
0
0
Teupitz
Query!
Country [216]
0
0
Germany
Query!
State/province [216]
0
0
Trier
Query!
Country [217]
0
0
Germany
Query!
State/province [217]
0
0
Troisdorf
Query!
Country [218]
0
0
Germany
Query!
State/province [218]
0
0
Ulm
Query!
Country [219]
0
0
Germany
Query!
State/province [219]
0
0
Unterhaching
Query!
Country [220]
0
0
Germany
Query!
State/province [220]
0
0
Wasserburg
Query!
Country [221]
0
0
Germany
Query!
State/province [221]
0
0
Weimar
Query!
Country [222]
0
0
Germany
Query!
State/province [222]
0
0
Weinheim
Query!
Country [223]
0
0
Germany
Query!
State/province [223]
0
0
Wermsdorf
Query!
Country [224]
0
0
Germany
Query!
State/province [224]
0
0
Wernigerode
Query!
Country [225]
0
0
Germany
Query!
State/province [225]
0
0
Wiesbaden
Query!
Country [226]
0
0
Germany
Query!
State/province [226]
0
0
Wolfenbüttel
Query!
Country [227]
0
0
Germany
Query!
State/province [227]
0
0
Wolfratshausen
Query!
Country [228]
0
0
Germany
Query!
State/province [228]
0
0
Würzburg
Query!
Country [229]
0
0
Germany
Query!
State/province [229]
0
0
Zwickau
Query!
Country [230]
0
0
Greece
Query!
State/province [230]
0
0
Crete
Query!
Country [231]
0
0
Greece
Query!
State/province [231]
0
0
Alexandroupoli
Query!
Country [232]
0
0
Greece
Query!
State/province [232]
0
0
Athens
Query!
Country [233]
0
0
Greece
Query!
State/province [233]
0
0
Ioannina
Query!
Country [234]
0
0
Greece
Query!
State/province [234]
0
0
Patras
Query!
Country [235]
0
0
Greece
Query!
State/province [235]
0
0
Thessaloniki
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Bari
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Bergamo
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Cagliari
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Cefalù
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Chieti
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Cuneo
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
Fidenza
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Firenze
Query!
Country [244]
0
0
Italy
Query!
State/province [244]
0
0
Foggia
Query!
Country [245]
0
0
Italy
Query!
State/province [245]
0
0
Gallarate
Query!
Country [246]
0
0
Italy
Query!
State/province [246]
0
0
Milano
Query!
Country [247]
0
0
Italy
Query!
State/province [247]
0
0
Napoli
Query!
Country [248]
0
0
Italy
Query!
State/province [248]
0
0
Orbassano
Query!
Country [249]
0
0
Italy
Query!
State/province [249]
0
0
Roma
Query!
Country [250]
0
0
Mexico
Query!
State/province [250]
0
0
Jalisco
Query!
Country [251]
0
0
Mexico
Query!
State/province [251]
0
0
Nuevo León
Query!
Country [252]
0
0
Mexico
Query!
State/province [252]
0
0
Aguascalientes
Query!
Country [253]
0
0
Mexico
Query!
State/province [253]
0
0
Estado de México
Query!
Country [254]
0
0
Mexico
Query!
State/province [254]
0
0
Leon
Query!
Country [255]
0
0
Mexico
Query!
State/province [255]
0
0
Mexico City
Query!
Country [256]
0
0
Mexico
Query!
State/province [256]
0
0
Mexico city
Query!
Country [257]
0
0
Mexico
Query!
State/province [257]
0
0
Puebla
Query!
Country [258]
0
0
Mexico
Query!
State/province [258]
0
0
San Luis Potosi
Query!
Country [259]
0
0
Netherlands
Query!
State/province [259]
0
0
Almelo
Query!
Country [260]
0
0
Netherlands
Query!
State/province [260]
0
0
Blaricum
Query!
Country [261]
0
0
Netherlands
Query!
State/province [261]
0
0
Breda
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Den Haag
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Eindhoven
Query!
Country [264]
0
0
Netherlands
Query!
State/province [264]
0
0
Geldrop
Query!
Country [265]
0
0
Netherlands
Query!
State/province [265]
0
0
Gouda
Query!
Country [266]
0
0
Netherlands
Query!
State/province [266]
0
0
Heerenveen
Query!
Country [267]
0
0
Netherlands
Query!
State/province [267]
0
0
Heerlen
Query!
Country [268]
0
0
Netherlands
Query!
State/province [268]
0
0
Helmond
Query!
Country [269]
0
0
Netherlands
Query!
State/province [269]
0
0
Hengelo
Query!
Country [270]
0
0
Netherlands
Query!
State/province [270]
0
0
Hoorn
Query!
Country [271]
0
0
Netherlands
Query!
State/province [271]
0
0
Leeuwarden
Query!
Country [272]
0
0
Netherlands
Query!
State/province [272]
0
0
Meppel
Query!
Country [273]
0
0
Netherlands
Query!
State/province [273]
0
0
Nieuwegein
Query!
Country [274]
0
0
Netherlands
Query!
State/province [274]
0
0
Nijmegen
Query!
Country [275]
0
0
Netherlands
Query!
State/province [275]
0
0
Roermond
Query!
Country [276]
0
0
Netherlands
Query!
State/province [276]
0
0
Rotterdam
Query!
Country [277]
0
0
Netherlands
Query!
State/province [277]
0
0
s Hertogenbosch
Query!
Country [278]
0
0
Netherlands
Query!
State/province [278]
0
0
Sittard-Geleen
Query!
Country [279]
0
0
Netherlands
Query!
State/province [279]
0
0
Tilburg
Query!
Country [280]
0
0
Netherlands
Query!
State/province [280]
0
0
Venray
Query!
Country [281]
0
0
Netherlands
Query!
State/province [281]
0
0
Woerden
Query!
Country [282]
0
0
Netherlands
Query!
State/province [282]
0
0
Zwolle
Query!
Country [283]
0
0
Norway
Query!
State/province [283]
0
0
Bergen
Query!
Country [284]
0
0
Norway
Query!
State/province [284]
0
0
Bodo
Query!
Country [285]
0
0
Norway
Query!
State/province [285]
0
0
Drammen
Query!
Country [286]
0
0
Norway
Query!
State/province [286]
0
0
Forde
Query!
Country [287]
0
0
Norway
Query!
State/province [287]
0
0
Fredrikstad
Query!
Country [288]
0
0
Norway
Query!
State/province [288]
0
0
Haugesund
Query!
Country [289]
0
0
Norway
Query!
State/province [289]
0
0
Lillehammer
Query!
Country [290]
0
0
Norway
Query!
State/province [290]
0
0
Lørenskog
Query!
Country [291]
0
0
Norway
Query!
State/province [291]
0
0
Molde
Query!
Country [292]
0
0
Norway
Query!
State/province [292]
0
0
Namsos
Query!
Country [293]
0
0
Norway
Query!
State/province [293]
0
0
Oslo
Query!
Country [294]
0
0
Norway
Query!
State/province [294]
0
0
Skien
Query!
Country [295]
0
0
Norway
Query!
State/province [295]
0
0
Stavanger
Query!
Country [296]
0
0
Norway
Query!
State/province [296]
0
0
Tromso
Query!
Country [297]
0
0
Norway
Query!
State/province [297]
0
0
Trondheim
Query!
Country [298]
0
0
Norway
Query!
State/province [298]
0
0
Tønsberg
Query!
Country [299]
0
0
Portugal
Query!
State/province [299]
0
0
Aveiro
Query!
Country [300]
0
0
Portugal
Query!
State/province [300]
0
0
Beja
Query!
Country [301]
0
0
Portugal
Query!
State/province [301]
0
0
Evora
Query!
Country [302]
0
0
Portugal
Query!
State/province [302]
0
0
Funchal
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Biogen
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00493298
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Trial related presentations / publications
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. 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. 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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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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https://clinicaltrials.gov/study/NCT00493298
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