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Baseline Visit (Day 1): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19.02.22 - 1 Formular, 3 Itemgruppen, 11 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Baseline Visit (Day 1)

Visit 6 (Week 24): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 19.02.22 - 1 Formular, 9 Itemgruppen, 31 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 6 (Week 24)

Visit 1 (Week 4): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 1 (Week 4)

Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 5 (Week 20)

Visit 2 (Week 8): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 2 Itemgruppen, 7 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 2 (Week 8)

Visit 17 (Week 168): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 17 (Week 168)

Visit 24 (Week 240) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 10 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 24 (Week 240)

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 18.02.22 - 1 Formular, 10 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Relapse assessment, Subject Identification, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Unsceduled relapse assessment visit

Visit 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.02.22 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 11 (Week 84)

Visit 23 (Week 228): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.02.22 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 23 (Week 228)

Visit 8 (Week 32) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.02.22 - 1 Formular, 10 Itemgruppen, 41 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Physical examination, EDSS Evaluation, Functional System Scores, EDSS, Additional and Results, Visual Function Test, Contrast Sensitivity Evaluation Binocular, Study Drug Accountability, Additional Surveys
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 8 (Week 32)

Visit 4 (Week 16): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

- 17.02.22 - 1 Formular, 3 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Subject Identification, Vital Signs, Study Drug Accountability
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Visit 4 (Week 16)

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