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Month 24: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 24

Month 36: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 36

Month 6: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 6

Month 18: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 18

Month 30: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 30

Month 12: Evoked Potentials Multiple Sclerosis ALAIN01 NCT02419378

- 03/06/2016 - 1 Formulier, 1 Itemgroep, 33 Data-elementen, 1 Taal
Itemgroep: Evoked Potentials
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Month 12

Screening: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

- 02/06/2016 - 1 Formulier, 1 Itemgroep, 32 Data-elementen, 1 Taal
Itemgroep: Vital Signs
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Please document clinically significant findings as Adverse Events. Clinical Significance is defined as any variation in physical findings that has medical relevance and may result in an alteration in medical care. Safety Blood and Urine Examinations: Please document the results for Serum Creatinine, Platelets and TSH on CRF-Pages "Safety Laboratory Assessments". Part: Screening

Screening: Medical History Multiple Sclerosis ALAIN01 NCT02419378

- 31/05/2016 - 1 Formulier, 2 Itemgroepen, 5 Data-elementen, 1 Taal
Itemgroepen: Medical History, Medical history List
Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Part: Screening

ToFingo V5 Study relevant assessments NCT02325440 - ToFingo Screening V5 Study relevant assessments NCT02325440

- 31/05/2016 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Study administration, MRI, Blood
Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

ToFingo Screening V1 Pre-examination NCT02325440

- 31/05/2016 - 1 Formulier, 6 Itemgroepen, 33 Data-elementen, 1 Taal
Itemgroepen: Study administration, MSFC (Multiple Sclerosis Functional Composite Measure), Last natalizumab dose, Ophthalmologic examination, Virus antibody status, ECG
Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

ToFingo Screening V1 Patient Information Background Information NCT02325440

- 31/05/2016 - 1 Formulier, 6 Itemgroepen, 25 Data-elementen, 1 Taal
Itemgroepen: Study Administration, Patient information, Informed consent, Inclusion/Exclusion Criteria, Relevant medical history/current medical conditions, MS history
Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069 - End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

- 29/05/2016 - 1 Formulier, 4 Itemgroepen, 11 Data-elementen, 1 Taal
Itemgroepen: End of Study / Discontinuation, Regular end of study, Early discontinuation, Signature
Study documentation part: End of Study/Discontinuation Study short name: DIMAT MS Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.: NCT02461069.

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