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The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 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. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Biological | Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Serious Adverse Events (SAEs) | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disability progression as determined by Expanded Disability Status Scale (EDSS) | Disability progression is defined as at least a 1.0 point increase on the 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. |
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Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Patients with RRMS who are being treated with natalizumab and patients who meet the criteria defined in the indication statement for prescription in Ireland. Existing patients will be enrolled retrospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Cork | County Cork | Ireland | |||
| Research site |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Up to 3 years |
| MS disease activity as determined by 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. | Up to 3 years |
| MS disease activity as determined by distribution of the total number of relapses during the study | Up to 3 years |
| MS disease activity as determined by time to first relapse | Up to 3 years |
| MS disease activity as determined by number of participants with relapse | Up to 3 years |
| MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics | Prognostic factors for disability progression and MS disease activity will be assessed in different participant cohorts stratified according to their baseline characteristics: Participant demographics including age, gender; Disease History, including diagnosis and duration at baseline; Baseline EDSS; Number of relapses within 1 and 2 years before baseline; MRI parameters at baseline; Prior use of disease modifying therapy, anti-neoplastic, immunosuppressant or immunomodulator therapy | Up to 3 years |
| MS disease activity as determined by MRI parameters | Up to 3 years |
| Evaluation of short-term disease outcomes as assessed by EDSS progression | Up to 1 year |
| Evaluation of short-term disease outcomes as assessed by occurrence of relapses | Up to 1 year |
| Dublin |
| County Dublin |
| Ireland |
| Research site | Galway | County Galway | Ireland |
| Research site | Tralee | County Kerry | Ireland |
| Research site | Sligo | County Sligo | Ireland |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |