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| Name | Class |
|---|---|
| ReMuS Registry | UNKNOWN |
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The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all participants taking natalizumab. The secondary objectives of the study are to estimate the incidence of SAEs, to estimate the incidence of SAEs among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and John Cunningham Virus (JCV) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab Cohort | The cohort will include participants with MS who are newly treated with natalizumab (administered as a standard of care/routine clinical practice) from 1st January 2019 including those participants who terminate or discontinue the treatment during the observational period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab | Up to 6 years | |
| Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Serious OI means such OI which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a birth defect in offspring. | Up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With SAEs | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. | Up to 6 years |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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The study will include participants with MS who are treated with natalizumab from the 1st of January 2019 and participating in the Czech National MS registry (ReMuS).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultní nemocnice Brno | Brno | Czechia | ||||
| Fakultní nemocnice u sv. Anny v Brně |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Demographic and clinical factors involve age, gender, duration of treatment, pregnancy, breastfeeding. | Up to 6 years |
| Number of Participants With Malignancies who are Taking Natalizumab | Up to 6 years |
| Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab | Up to 6 years |
| Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab | Up to 6 years |
| Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab | Up to 6 years |
| Brno |
| Czechia |
| Nemocnice České Budějovice | České Budějovice | Czechia |
| Fakultní nemocnice Hradec Králové | Hradec Králové | Czechia |
| Nemocnice Jihlava | Jihlava | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | Czechia |
| Fakultní nemocnice v Ostravě | Ostrava | Czechia |
| Nemocnice Pardubického kraje | Pardubice | Czechia |
| Fakultní nemocnice v Plzni | Pilsen | Czechia |
| Fakultní nemocnice Královské Vinohrady v Praze | Prague | Czechia |
| Fakultní nemocniceMotol v Praze | Prague | Czechia |
| Fakultní Thomayerova nemocnice v Praze v Krči | Prague | Czechia |
| Všeobecná fakultní nemocnice v Praze | Prague | Czechia |
| Nemocnice Teplice | Teplice | Czechia |
| Krajská nemocnice T. Bati ve Zlíně | Zlín | Czechia |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D007968 | Leukoencephalopathy, Progressive Multifocal |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D014777 | Virus Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D012897 | Slow Virus Diseases |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D056784 | Leukoencephalopathies |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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