ID
15419
Descripción
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
Link
https://clinicaltrials.gov/ct2/show/NCT02325440
Palabras clave
Versiones (6)
- 27/5/16 27/5/16 -
- 27/5/16 27/5/16 -
- 27/5/16 27/5/16 -
- 27/5/16 27/5/16 -
- 30/5/16 30/5/16 - Julian Varghese
- 31/5/16 31/5/16 -
Subido en
31 de mayo de 2016
DOI
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Licencia
Creative Commons BY 4.0
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ToFingo Screening V1 Patient Information Background Information NCT02325440
ToFingo Screening V1 Patient Information Background Information NCT02325440
Descripción
Patient information
Alias
- UMLS CUI-1
- C1955348
Descripción
Last name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0421448
Descripción
First name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1443235
Descripción
Sex
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Screening failure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1512714
Descripción
Specify reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1512714
- UMLS CUI [1,2]
- C0566251
Descripción
Informed consent
Alias
- UMLS CUI-1
- C0021430
Descripción
Informed consent (Study)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Date of Informed consent (Study)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Descripción
Informed consent lumbal puncture (optional)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
Descripción
Date of Informed Consent lumbar puncture
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
- UMLS CUI [1,3]
- C0001108
Descripción
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Descripción
Inclusion criteria: Patient meets all inclusion criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1302261
Descripción
Exclusion criteria: Patient meets any exclusion criteria
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0680251
Descripción
Relevant medical history/current medical conditions
Alias
- UMLS CUI-1
- C0262926
Descripción
Diagnosis/Surgery
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0543467
Descripción
Date of Diagnosis/Surgery
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0011008
Descripción
Active at start of study
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2316983
Descripción
Comments
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0947611
Descripción
MS history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026769
Descripción
Date of confirmed MS diagnosis
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0011008
Descripción
Date of first MS symptoms
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Descripción
Previous MS therapies received
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C3539076
Descripción
if yes, please specify
Tipo de datos
text
Alias
- UMLS CUI [1]
- C4020596
Descripción
if other, please specify
Tipo de datos
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])
C0680251 (UMLS CUI-2)
C0543467 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
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])