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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS48753 | Other Identifier | EU PAS register number |
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The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.
The study will collect data prospectively and retrospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Naive Participants | Per standard of care, participants with MS enrolled in selected MS registries, who are natalizumab-naïve and other MS mAb-therapy-naive will receive natalizumab 300 mg, SC injection according to decision of the treating physician. |
| |
| Cohort 2: Natalizumab Experienced | Per standard of care, participants with MS enrolled in selected MS registries, who have previously received natalizumab IV will be switched from natalizumab IV to SC administration to receive natalizumab 300 mg, SC injection according to decision of the treating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs) | Up to 1.75 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs) | Up to 1.75 years | |
| Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status |
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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 available EU MS registry participants.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cambridge | Massachusetts | 02142 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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SAE is any untoward medical occurrence 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 1.75 years |
| Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status | Up to 1.75 years |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| 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 |
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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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