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TOP: IMA-06-02 Tysabri® Observational Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Biogen Idec
Sponsor:
Collaborator:
Biogen Idec Australia
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00493298
First received: June 27, 2007
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri® (natalizumab) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.


Condition
Relapsing-Remitting Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TOP: Tysabri® Observational Program

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    An SAE is any untoward medical occurrence that at any dose: • results in death; • in the view of the Investigator, places the patient at immediate risk of death (a life-threatening event); • requires inpatient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; or • results in a congenital anomaly/medically significant birth defect. MS relapses fulfilling the criteria of a SAE are not be considered SAEs for the purpose of the study.


Secondary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Distribution of the total number of relapses [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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 to first relapse [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
  • Percentage of participants with relapse [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants with Disability Progression [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants that Reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Whose Expanded Disability Status Score (EDSS) Worsened, Stabilized or Improved and Sustained over 6 Months [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • Evaluation of baseline disease characteristics as prognostic indicators for disease activity and disability progression over time [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
    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.

  • 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 10 years ] [ Designated as safety issue: No ]
    Short term outcomes evaluated will include: • EDSS progression during first 12 months • Occurrence of relapses during first 12 months


Estimated Enrollment: 6000
Study Start Date: June 2007
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Detailed Description:

TOP is an epidemiological observational study of participants receiving Tysabri®, with each participant to be followed for up to 10 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493298

Contacts
Contact: Biogen Idec clinicaltrials@biogenidec.com

  Show 311 Study Locations
Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia
Investigators
Study Director: Medical Director Biogen Idec
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00493298     History of Changes
Other Study ID Numbers: IMA-06-02
Study First Received: June 27, 2007
Last Updated: October 27, 2014
Health Authority: Canada: Ethics Review Committee
Belgium: Federal Agency for Medicinal Products and Health Products
France: Ministry of Health
Italy: Ethics Committee
Norway: Ethics Committee
Spain: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Argentina: Human Research Bioethics Committee
Portugal: Ethics Committee for Clinical Research
France: Institutional Ethical Committee
Greece: Ministry of Health and Welfare
Italy: Ministry of Health
Slovenia: Ethics Committee
Norway: Norwegian Medicines Agency
Argentina: Ministry of Health
Spain: Ethics Committee
Finland: Ethics Committee
Czech Republic: State Institute for Drug Control
Australia: National Health and Medical Research Council
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Mexico: Ethics Committee
Belgium: Institutional Review Board
Germany: Ethics Commission
Mexico: Ministry of Health
European Union: European Medicines Agency
Australia: Human Research Ethics Committee
United Kingdom: Research Ethics Committee
Slovenia: Ministry of Health
Canada: Health Canada
Netherlands: Ministry of Health, Welfare and Sport
Finland: Finnish Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Portugal: Health Ethic Committee
United Kingdom: National Institute for Health Research

Keywords provided by Biogen Idec:
disease progression
Multiple Sclerosis
disease activity
natalizumab
long-term safety
Tysabri®

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014