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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR TECFIDERA

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Clinical Trials for Tecfidera

Trial ID Title Status Sponsor Phase Summary
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study Recruiting Sheffield Teaching Hospitals NHS Foundation Trust Phase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study Recruiting University of Sao Paulo Phase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study Recruiting Uppsala University Phase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study Recruiting Northwestern University Phase 3 Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rATG versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tecfidera

Condition Name

Condition Name for Tecfidera
Intervention Trials
Multiple Sclerosis 23
Relapsing-Remitting Multiple Sclerosis 13
Multiple Sclerosis, Relapsing-Remitting 8
Relapsing Remitting Multiple Sclerosis 4
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Condition MeSH

Condition MeSH for Tecfidera
Intervention Trials
Multiple Sclerosis 47
Sclerosis 40
Multiple Sclerosis, Relapsing-Remitting 25
Multiple Sclerosis, Chronic Progressive 3
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Clinical Trial Locations for Tecfidera

Trials by Country

Trials by Country for Tecfidera
Location Trials
United States 289
France 34
United Kingdom 23
Canada 22
Germany 16
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Trials by US State

Trials by US State for Tecfidera
Location Trials
Texas 15
New York 13
California 13
Florida 12
Colorado 12
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Clinical Trial Progress for Tecfidera

Clinical Trial Phase

Clinical Trial Phase for Tecfidera
Clinical Trial Phase Trials
Phase 4 19
Phase 3 10
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Tecfidera
Clinical Trial Phase Trials
Recruiting 18
Completed 12
Active, not recruiting 7
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Clinical Trial Sponsors for Tecfidera

Sponsor Name

Sponsor Name for Tecfidera
Sponsor Trials
Biogen 35
EMD Serono 3
Sheffield Teaching Hospitals NHS Foundation Trust 2
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Sponsor Type

Sponsor Type for Tecfidera
Sponsor Trials
Industry 44
Other 31
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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Farmers Insurance
Federal Trade Commission
Express Scripts
Deloitte
Cantor Fitzgerald
Merck
Chinese Patent Office
McKinsey

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