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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00493298




Registration number
NCT00493298
Ethics application status
Date submitted
27/06/2007
Date registered
28/06/2007
Date last updated
1/06/2020

Titles & IDs
Public title
Tysabri Observational Program
Scientific title
TOP: Tysabri® Observational Program
Secondary ID [1] 0 0
IMA-06-02
Universal Trial Number (UTN)
Trial acronym
TOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - natalizumab

natalizumab - According to the local prescribing information


Treatment: Drugs: natalizumab
According to the local prescribing information

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with serious adverse events (SAE)
Timepoint [1] 0 0
Up to 15 years
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Yearly for up to 15 years
Secondary outcome [2] 0 0
Distribution of the total number of relapses
Timepoint [2] 0 0
Yearly for up to 15 years
Secondary outcome [3] 0 0
Time to first relapse
Timepoint [3] 0 0
Yearly for up to 15 years
Secondary outcome [4] 0 0
Percentage of participants with relapse
Timepoint [4] 0 0
Yearly for up to 15 years
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Yearly for up to 15 years
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Yearly for up to 15 years
Secondary outcome [7] 0 0
Percentage of participants whose EDSS worsened, stabilized or improved and sustained over 6 months
Timepoint [7] 0 0
Yearly for up to 15 years
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Yearly for up to 15 years
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Yearly for up to 15 years

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of Progressive Multifocal Leukoencephalopathy or other opportunistic
infections, or an increased risk of opportunistic infections

- History of positive anti-natalizumab 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research site - Camperdown
Recruitment hospital [2] 0 0
Research site - Liverpool
Recruitment hospital [3] 0 0
Research site - New Lambton Heights
Recruitment hospital [4] 0 0
Research Site - St. Leonards
Recruitment hospital [5] 0 0
Research Site - Auchenflower
Recruitment hospital [6] 0 0
Research site - Gold Coast
Recruitment hospital [7] 0 0
Research site - Adelaide
Recruitment hospital [8] 0 0
Research Site - North Adelaide
Recruitment hospital [9] 0 0
Research site - Box Hill
Recruitment hospital [10] 0 0
Research site - Fitzroy
Recruitment hospital [11] 0 0
Research site - Heidelberg
Recruitment hospital [12] 0 0
Research Site - Melbourne
Recruitment hospital [13] 0 0
Research site - Parkville
Recruitment hospital [14] 0 0
Research site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
9726 - Gold Coast
Recruitment postcode(s) [7] 0 0
5042 - Adelaide
Recruitment postcode(s) [8] 0 0
5006 - North Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
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Buenos Aires
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Argentina
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CABA, Buenos Aires
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Aalst
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Brugge
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Brussel
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Charleroi
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Edegem
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Fraiture
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Genk
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Gent
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Leuven
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Liège
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Malmedy
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Melsbroek
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Ottignies
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Overpelt
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Sijsele
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Tournai
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Wilrijk
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Woluwe-Saint-Lambert
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Pardubice
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Plzen
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Czechia
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Prague 10
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Czechia
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Prague 4
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Czechia
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Prague
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Czechia
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Praha 5
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Pori
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Tampere
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Neuruppin
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Nürnberg
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Oldenburg
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Olpe
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Osnabrück
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Paderborn
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Germany
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Potsdam
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Regensburg
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Remscheid
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Rüdersdorf
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Rülzheim
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Schlüchtern
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Schorndorf
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Schwaebisch
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Siegen
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Sinsheim
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Stade
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Stadtroda
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Stuttgart
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Teupitz
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Trier
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Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to assess the long-term safety and impact on disease
activity and progression of natalizumab in participants with relapsing remitting multiple
sclerosis (RRMS) in a clinical practice setting.
Trial website
https://clinicaltrials.gov/show/NCT00493298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications