An observational study in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 422 sites in 18 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by Biogen · 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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 6,620 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
According to the local prescribing information
Drug: Tysabri
According to the local prescribing information
Also known as: BG00002, natalizumab
Number of Participants with Serious Adverse Events (SAE)
Time frame: Up to 15 years
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.
Time frame: Yearly for up to 15 years
Distribution of the Total Number of Relapses
Time frame: Yearly for up to 15 years
Time to First Relapse
Time frame: Yearly for up to 15 years
Percentage of Participants with Relapse
Time frame: Yearly for up to 15 years
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.
Time frame: Yearly for up to 15 years
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.
Time frame: Yearly for up to 15 years
Percentage of Participants whose EDSS Worsened, Stabilized or Improved and Sustained over 6 Months
Time frame: Yearly for up to 15 years
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.
Time frame: Yearly for up to 15 years
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
Time frame: Yearly for up to 15 years
Showing the first 100 of 422 sites across 18 countries.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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