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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005082-13 |
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The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by α4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Natalizumab | Experimental | 300 mg intravenously (IV) every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Biological | As specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| predose (trough) concentrations from multiple dosing (Cpredose) | Up to week 16 | |
| maximum plasma concentration (Cmax) | Up to Week 16 | |
| time to maximum plasma concentration (Tmax) | Up to Week 16 | |
| area under the plasma concentration curve from time of first dose to infinity (AUCinf) | Up to Week 16 | |
| apparent clearance (Cl/F) | Up to Week 16 | |
| volume of distribution | Up to Week 16 | |
| elimination half-life (t1/2) | Up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| the average and minimum saturation values of α4 integrin over the dosing interval | Up to Week 16 | |
| incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs | Up to Week 16 |
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Key Inclusion Criteria:
- Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load, as compared to a previous recent magnetic resonance imaging (MRI)
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cefalù | Italy | ||||
| Research Site |
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| Label | URL |
|---|---|
| EudraCT Tabulated Result | View source |
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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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| the presence of anti-natalizumab antibodies | Up to Week 16 |
| Gallarate |
| Italy |
| Research Site | Milan | Italy |
| Research Site | Padua | Italy |
| Research Site | Rome | Italy |
| 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 |