ID
15335
Description
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
Lien
https://clinicaltrials.gov/ct2/show/NCT02325440
Mots-clés
Versions (6)
- 27/05/2016 27/05/2016 -
- 27/05/2016 27/05/2016 -
- 27/05/2016 27/05/2016 -
- 27/05/2016 27/05/2016 -
- 30/05/2016 30/05/2016 - Julian Varghese
- 31/05/2016 31/05/2016 -
Téléchargé le
27 mai 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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ToFingo Screening V1 Patient Information Background Information NCT02325440
ToFingo Screening V1 Patient Information Background Information NCT02325440
Description
Informed consent
Alias
- UMLS CUI-1
- C0021430
Description
Informed consent (Study)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Date of Informed consent (Study)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
Informed consent lumbal puncture (optional)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
Description
Date of Informed Consent lumbar puncture
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
- UMLS CUI [1,3]
- C0001108
Description
Relevant medical history/current medical conditions
Alias
- UMLS CUI-1
- C0262926
Description
Diagnosis/Surgery
Type de données
text
Alias
- UMLS CUI [1]
- C0011900|C0543467
Description
Date of Diagnosis/Surgery
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011900|C0543467
- UMLS CUI [1,2]
- C0011008
Description
Active at start of study
Type de données
boolean
Description
Comments
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
MS history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026769
Description
Date of confirmed MS diagnosis
Type de données
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0011008
Description
Date of first MS symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Description
Previous MS therapies received
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C3539076
Description
if yes, please specify
Type de données
text
Alias
- UMLS CUI [1]
- C4020596
Description
if other, please specify
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
ToFingo Screening V1 Patient Information Background Information NCT02325440
C0566251 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0037943 (UMLS CUI [1,2])
C0037943 (UMLS CUI [1,2])
C0001108 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3539076 (UMLS CUI [1,2])