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The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Czech Republic | Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic |
| |
| Belgium | Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| natalizumab | Drug | Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change over time in the number of participants free of new or enlarging FLAIR lesions | Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm). | Treatment years 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF] | Post long term treatment with natalizumab (>2 years) through Year 4 | |
| Annualized brain volume change rate as assessed by percent brain volume change [PBVC] |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants who have been receiving treatment with natalizumab for ≥24 months.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Brussels | Belgium | ||||
| Research Site 2 |
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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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| Post long term treatment with natalizumab (>2 years) through Year 4 |
| Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy) | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Cumulative number of new ≥6-month confirmed T1-hypointense lesions | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Annualized T1-hypointense and FLAIR lesion volume change | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Cumulative percent change in T1-hypointense and FLAIR lesion volume | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions | No relapse and no ≥6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Number of total participants and 4-year completers with NEDA as measured by clinical measures | No relapse and no ≥6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Number of total participants and 4-year completers with NEDA as measured by radiological measures | No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Number of participants with brain volume loss ≤0.2% and ≤0.4% | Post long term treatment with natalizumab (>2 years) through Year 4 |
| Brussels |
| Belgium |
| Research Site | Overpelt | Belgium |
| Research Site | Prague | Czechia |
| 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 |