Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tysabri Observational Program (TOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 27, 2007
First Posted Date June 28, 2007
Last Update Posted Date September 6, 2019
Actual Study Start Date June 29, 2007
Estimated Primary Completion Date December 28, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2019)
Number of participants with serious adverse events (SAE) [ Time Frame: Up to 15 years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00493298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 2, 2019)
  • 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.
  • 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 [ 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.
  • 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.
  • 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 [ 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.
  • 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tysabri Observational Program
Official Title TOP: Tysabri® Observational Program
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Relapsing-Remitting Multiple Sclerosis
Intervention Drug: natalizumab
According to the local prescribing information
Other Names:
  • Tysabri
  • BG00002
Study Groups/Cohorts natalizumab
According to the local prescribing information
Intervention: Drug: natalizumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 5, 2019)
6620
Original Estimated Enrollment
 (submitted: June 27, 2007)
5000
Estimated Study Completion Date December 28, 2028
Estimated Primary Completion Date December 28, 2028   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   Finland,   France,   Germany,   Greece,   Italy,   Mexico,   Netherlands,   Norway,   Portugal,   Slovakia,   Spain,   United Kingdom
Removed Location Countries Czech Republic,   Denmark,   Switzerland
 
Administrative Information
NCT Number NCT00493298
Other Study ID Numbers IMA-06-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date September 2019