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Tysabri Observational Program (TOP)

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ClinicalTrials.gov Identifier: NCT00493298
Recruitment Status : Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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.

Condition or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis Drug: natalizumab

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 6620 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TOP: Tysabri® Observational Program
Actual Study Start Date : June 29, 2007
Estimated Primary Completion Date : December 28, 2028
Estimated Study Completion Date : December 28, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
natalizumab
According to the local prescribing information
 Drug: natalizumab
According to the local prescribing information
Other Names:
  • Tysabri
  • BG00002


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with serious adverse events (SAE) [ Time Frame: Up to 15 years ]

Secondary Outcome Measures :
  1. Annualized Relapse Rate (ARR) [ Time Frame: Yearly for up to 15 years ]
    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.

  2. Distribution of the total number of relapses [ Time Frame: Yearly for up to 15 years ]
  3. Time to first relapse [ Time Frame: Yearly for up to 15 years ]
  4. Percentage of participants with relapse [ Time Frame: Yearly for up to 15 years ]
  5. Percentage of participants with disability progression [ Time Frame: Yearly for up to 15 years ]
    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.

  6. Percentage of participants that reach Expanded Disability Status Score (EDSS) milestones indicating increasing disability [ Time Frame: Yearly for up to 15 years ]
    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.

  7. Percentage of participants whose EDSS worsened, stabilized or improved and sustained over 6 months [ Time Frame: Yearly for up to 15 years ]
  8. Evaluation of baseline disease characteristics as prognostic indicators for disease activity and disability progression over time [ Time Frame: Yearly for up to 15 years ]
    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.

  9. Evaluation of short-term (1 year) disease outcomes as prognostic indicators for disease activity and disability progression over time [ Time Frame: Yearly for up to 15 years ]
    Short term outcomes evaluated will include: EDSS progression during first 12 months; Occurrence of relapses during first 12 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with RRMS who are therapy-naïve to natalizumab and who meet the criteria defined in the indication statement for prescription in the respective country.
Criteria

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-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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493298


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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Additional Information:
TOP eDCT  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00493298     History of Changes
Other Study ID Numbers: IMA-06-02
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by Biogen:
disease progression
Multiple Sclerosis
disease activity
 Tysabri
natalizumab
long-term safety
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs