ID
15422
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 (3)
- 27/05/2016 27/05/2016 -
- 31/05/2016 31/05/2016 -
- 31/05/2016 31/05/2016 -
Téléchargé le
31 mai 2016
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
ToFingo Screening V1 Pre-examination NCT02325440
ToFingo Screening V1 Pre-examination NCT02325440
- StudyEvent: ODM
Description
MSFC (Multiple Sclerosis Functional Composite Measure)
Alias
- UMLS CUI-1
- C0026769
- UMLS CUI-2
- C0449820
Description
Last natalizumab dose
Alias
- UMLS CUI-1
- C1762893
- UMLS CUI-2
- C1172734
Description
Ophthalmologic examination
Alias
- UMLS CUI-1
- C0200149
Description
Opthalmologic examination: Result
Type de données
text
Alias
- UMLS CUI [1]
- C0200149
Description
Opthalmologic examination: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200149
- UMLS CUI [1,2]
- C0947611
Description
History of uveitis or diabetes melitus: Result
Type de données
text
Alias
- UMLS CUI [1]
- C0042164
- UMLS CUI [2]
- C0011849
Description
History of uveitis or diabetes mellitus: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042164
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [2,1]
- C0011849
- UMLS CUI [2,2]
- C0947611
Description
Abnormalities: Result
Type de données
text
Alias
- UMLS CUI [1]
- C1704258
Description
Abnormalities: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0947611
Description
Virus antibody status
Alias
- UMLS CUI-1
- C0201278
Description
Anti-JCV-IgG: Result
Type de données
float
Alias
- UMLS CUI [1]
- C3511565
Description
Anti-JCV-IgG: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C3511565
- UMLS CUI [1,2]
- C0047611
Description
Anti-VZV-IgG: Result
Type de données
float
Unités de mesure
- mU/ml
Alias
- UMLS CUI [1]
- C0443710
Description
Anti-VZV-IgG: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0443710
- UMLS CUI [1,2]
- C0947611
Description
Anti-HIV 1+2: Result
Type de données
float
Alias
- UMLS CUI [1]
- C0019683
Description
Anti-HIV 1+2: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019683
- UMLS CUI [1,2]
- C0947611
Description
HBsAg (Hepatitis B Surface Antigen): Result
Type de données
float
Alias
- UMLS CUI [1]
- C0201477
Description
HBsAg (Hepatitis B Surface Antigen): Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0201477
- UMLS CUI [1,2]
- C0947611
Description
Anti-HCV: Result
Type de données
float
Alias
- UMLS CUI [1,1]
- C0166049
- UMLS CUI [1,2]
- C0242485
Description
Anti-HCV: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0201485
- UMLS CUI [1,2]
- C0947611
Description
Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
Type de données
float
Alias
- UMLS CUI [1]
- C0919754
Description
Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0919754
- UMLS CUI [1,2]
- C0947611
Description
Anti-Rubeola-IgG (Measles virus): Result
Type de données
float
Alias
- UMLS CUI [1]
- C0523315
Description
Anti-Rubeola-IgG (Measles virus): Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0523315
- UMLS CUI [1,2]
- C0947611
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
AV-Block 2nd degree, Type II: Result
Type de données
boolean
Alias
- UMLS CUI [1]
- C0155700
Description
AV-Block 2nd degree, Type II: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0155700
- UMLS CUI [1,2]
- C0947611
Description
AV-Block 3rd degree: Result
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151517
Description
AV-Block 3rd degree: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0151517
- UMLS CUI [1,2]
- C0947611
Description
QTc intervall: Result
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0489625
Description
QTc intervall: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0947611
Description
Abnormalities: Result
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C1623258
Description
Abnormalities: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C1623258
- UMLS CUI [1,3]
- C0947611
Similar models
ToFingo Screening V1 Pre-examination NCT02325440
- StudyEvent: ODM
C0449820 (UMLS CUI-2)
C0449820 (UMLS CUI [1,2])
C1172734 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0947611 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0947611 (UMLS CUI [1,2])
C0047611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])