Tysabri Observational Program (TOP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by Biogen
Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00493298
First received: June 27, 2007
Last updated: September 20, 2016
Last verified: September 2016
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Purpose
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 | Intervention |
|---|---|
|
Relapsing-Remitting Multiple Sclerosis |
Drug: natalizumab |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | TOP: Tysabri® Observational Program |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
Further study details as provided by Biogen:
Primary Outcome Measures:
- Number of participants with serious adverse events (SAE) [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Annualized Relapse Rate (ARR) [ 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 ]
- 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 ]
- 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 EDSS worsened, stabilized or improved and sustained over 6 months [ Time Frame: Yearly for up to 10 years ] [ Designated as safety issue: No ]
- 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: | December 2027 |
| Estimated Primary Completion Date: | December 2027 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
natalizumab
According to the local prescribing information
|
Drug: natalizumab
According to the local prescribing information
Other Names:
|
Detailed Description:
TOP is an epidemiological observational study of participants receiving natalizumab, 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 natalizumab 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 (Adult) |
| Genders Eligible for Study: | Both |
| 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
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
Show 376 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493298
Contacts
| Contact: Biogen | clinicaltrials@biogen.com |
Show 376 Study Locations
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT00493298 History of Changes |
| Other Study ID Numbers: | IMA-06-02 |
| Study First Received: | June 27, 2007 |
| Last Updated: | September 20, 2016 |
| 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 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 Slovakia: State Institute for Drug Control Germany: Ethics Commission Mexico: Ministry of Health European Union: European Medicines Agency Australia: Human Research Ethics Committee United Kingdom: Research Ethics Committee 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:
|
disease progression Multiple Sclerosis disease activity |
Tysabri natalizumab long-term safety |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting 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 |
ClinicalTrials.gov processed this record on September 27, 2016