ID

15424

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

Link

https://clinicaltrials.gov/ct2/show/NCT02325440

Keywords

Versions (3)
  1. 5/27/16 5/27/16 -
  2. 5/31/16 5/31/16 -
  3. 5/31/16 5/31/16 -
Uploaded on

May 31, 2016

DOI

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License

Creative Commons BY 4.0
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ToFingo Screening V1 Pre-examination NCT02325440

English

ToFingo Screening V1 Pre-examination NCT02325440

1 forms  
Study administration
Description

Study administration

Data entry for this CRF completed
Description

Data entry for this CRF completed

Data type

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Current patient (ID)
Description

Current patient (ID)

Data type

text

Alias
UMLS CUI [1]
C2348585
MSFC (Multiple Sclerosis Functional Composite Measure)
Description

MSFC (Multiple Sclerosis Functional Composite Measure)

Alias
UMLS CUI-1
C0026769
UMLS CUI-2
C0449820
Endscore
Description

Endscore

Data type

integer

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0450973
UMLS CUI [1,3]
C0449820
Last natalizumab dose
Description

Last natalizumab dose

Alias
UMLS CUI-1
C1762893
UMLS CUI-2
C1172734
Last natalizumab dose taken (300mg)
Description

Last natalizumab dose taken (300mg)

Data type

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1172734
Ophthalmologic examination
Description

Ophthalmologic examination

Alias
UMLS CUI-1
C0200149
Opthalmologic examination: Result
Description

Opthalmologic examination: Result

Data type

text

Alias
UMLS CUI [1]
C0200149
Opthalmologic examination: Comment
Description

Opthalmologic examination: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0947611
History of uveitis or diabetes mellitus: Result
Description

History of uveitis or diabetes melitus: Result

Data type

text

Alias
UMLS CUI [1]
C0042164
UMLS CUI [2]
C0011849
History of uveitis or diabetes mellitus: Comment
Description

History of uveitis or diabetes mellitus: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0042164
UMLS CUI [1,2]
C0947611
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0947611
Abnormalities: Result
Description

Abnormalities: Result

Data type

text

Alias
UMLS CUI [1]
C1704258
Abnormalities: Comment
Description

Abnormalities: Comment

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0947611
Virus antibody status
Description

Virus antibody status

Alias
UMLS CUI-1
C0201278
Anti-JCV-IgG: Result
Description

Anti-JCV-IgG: Result

Data type

float

Alias
UMLS CUI [1]
C3511565
Anti-JCV-IgG: Comment
Description

Anti-JCV-IgG: Comment

Data type

text

Alias
UMLS CUI [1,1]
C3511565
UMLS CUI [1,2]
C0047611
Anti-VZV-IgG: Result
Description

Anti-VZV-IgG: Result

Data type

float

Measurement units
  • mU/ml
Alias
UMLS CUI [1]
C0443710
mU/ml
Anti-VZV-IgG: Comment
Description

Anti-VZV-IgG: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0443710
UMLS CUI [1,2]
C0947611
Anti-HIV 1+2: Result
Description

Anti-HIV 1+2: Result

Data type

float

Alias
UMLS CUI [1]
C0019683
Anti-HIV 1+2: Comment
Description

Anti-HIV 1+2: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0019683
UMLS CUI [1,2]
C0947611
HBsAg (Hepatitis B Surface Antigen): Result
Description

HBsAg (Hepatitis B Surface Antigen): Result

Data type

float

Alias
UMLS CUI [1]
C0201477
HBsAg (Hepatitis B Surface Antigen): Comment
Description

HBsAg (Hepatitis B Surface Antigen): Comment

Data type

text

Alias
UMLS CUI [1,1]
C0201477
UMLS CUI [1,2]
C0947611
Anti-HCV: Result
Description

Anti-HCV: Result

Data type

float

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C0242485
Anti-HCV: Comment
Description

Anti-HCV: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0201485
UMLS CUI [1,2]
C0947611
Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
Description

Anti-HSV 1/2-IgG (Herpes Simplex virus): Result

Data type

float

Alias
UMLS CUI [1]
C0919754
Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
Description

Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment

Data type

text

Alias
UMLS CUI [1,1]
C0919754
UMLS CUI [1,2]
C0947611
Anti-Rubeola-IgG (Measles virus): Result
Description

Anti-Rubeola-IgG (Measles virus): Result

Data type

float

Alias
UMLS CUI [1]
C0523315
Anti-Rubeola-IgG (Measles virus): Comment
Description

Anti-Rubeola-IgG (Measles virus): Comment

Data type

text

Alias
UMLS CUI [1,1]
C0523315
UMLS CUI [1,2]
C0947611
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
AV-Block 2nd degree, Type II: Result
Description

AV-Block 2nd degree, Type II: Result

Data type

boolean

Alias
UMLS CUI [1]
C0155700
AV-Block 2nd degree, Type II: Comment
Description

AV-Block 2nd degree, Type II: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0155700
UMLS CUI [1,2]
C0947611
AV-Block 3rd degree: Result
Description

AV-Block 3rd degree: Result

Data type

boolean

Alias
UMLS CUI [1]
C0151517
AV-Block 3rd degree: Comment
Description

AV-Block 3rd degree: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0151517
UMLS CUI [1,2]
C0947611
QTc intervall: Result
Description

QTc intervall: Result

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489625
msec
QTc intervall: Comment
Description

QTc intervall: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0947611
Abnormalities: Result
Description

Abnormalities: Result

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1623258
Abnormalities: Comment
Description

Abnormalities: Comment

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1623258
UMLS CUI [1,3]
C0947611
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Similar models

ToFingo Screening V1 Pre-examination NCT02325440

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Data entry for this CRF completed
Item
Data entry for this CRF completed
boolean
C3899518 (UMLS CUI [1])
Assessment Date
Item
Assessment date
date
C0011008 (UMLS CUI [1])
Current patient (ID)
Item
Current patient (ID)
text
C2348585 (UMLS CUI [1])
Item Group
MSFC (Multiple Sclerosis Functional Composite Measure)
C0026769 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
Endscore
Item
Endscore
integer
C0026769 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item Group
Last natalizumab dose
C1762893 (UMLS CUI-1)
C1172734 (UMLS CUI-2)
Last natalizumab dose taken (300mg)
Item
Last natalizumab dose taken (300mg)
date
C1762893 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Item Group
Ophthalmologic examination
C0200149 (UMLS CUI-1)
Opthalmologic examination: Result
Item
Opthalmologic examination: Result
text
C0200149 (UMLS CUI [1])
Opthalmologic examination: Comment
Item
Opthalmologic examination: Comment
text
C0200149 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
History of uveitis or diabetes melitus: Result
Item
History of uveitis or diabetes mellitus: Result
text
C0042164 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
History of uveitis or diabetes mellitus: Comment
Item
History of uveitis or diabetes mellitus: Comment
text
C0042164 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Abnormalities: Result
Item
Abnormalities: Result
text
C1704258 (UMLS CUI [1])
Abnormalities: Comment
Item
Abnormalities: Comment
text
C1704258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Virus antibody status
C0201278 (UMLS CUI-1)
Anti-JCV-IgG: Result
Item
Anti-JCV-IgG: Result
float
C3511565 (UMLS CUI [1])
Anti-JCV-IgG: Comment
Item
Anti-JCV-IgG: Comment
text
C3511565 (UMLS CUI [1,1])
C0047611 (UMLS CUI [1,2])
Anti-VZV-IgG: Result
Item
Anti-VZV-IgG: Result
float
C0443710 (UMLS CUI [1])
Anti-VZV-IgG: Comment
Item
Anti-VZV-IgG: Comment
text
C0443710 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Anti-HIV 1+2: Result
Item
Anti-HIV 1+2: Result
float
C0019683 (UMLS CUI [1])
Anti-HIV 1+2: Comment
Item
Anti-HIV 1+2: Comment
text
C0019683 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
HBsAg (Hepatitis B Surface Antigen): Result
Item
HBsAg (Hepatitis B Surface Antigen): Result
float
C0201477 (UMLS CUI [1])
HBsAg (Hepatitis B Surface Antigen): Comment
Item
HBsAg (Hepatitis B Surface Antigen): Comment
text
C0201477 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Anti-HCV: Result
Item
Anti-HCV: Result
float
C0166049 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Anti-HCV: Comment
Item
Anti-HCV: Comment
text
C0201485 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
Item
Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
float
C0919754 (UMLS CUI [1])
Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
Item
Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
text
C0919754 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Anti-Rubeola-IgG (Measles virus): Result
Item
Anti-Rubeola-IgG (Measles virus): Result
float
C0523315 (UMLS CUI [1])
Anti-Rubeola-IgG (Measles virus): Comment
Item
Anti-Rubeola-IgG (Measles virus): Comment
text
C0523315 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
ECG
C1623258 (UMLS CUI-1)
AV-Block 2nd degree, Type II: Result
Item
AV-Block 2nd degree, Type II: Result
boolean
C0155700 (UMLS CUI [1])
AV-Block 2nd degree, Type II: Comment
Item
AV-Block 2nd degree, Type II: Comment
text
C0155700 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
AV-Block 3rd degree: Result
Item
AV-Block 3rd degree: Result
boolean
C0151517 (UMLS CUI [1])
AV-Block 3rd degree: Comment
Item
AV-Block 3rd degree: Comment
text
C0151517 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
QTc intervall: Result
Item
QTc intervall: Result
float
C0489625 (UMLS CUI [1])
QTc intervall: Comment
Item
QTc intervall: Comment
text
C0489625 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Abnormalities: Result
Item
Abnormalities: Result
boolean
C1704258 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Abnormalities: Comment
Item
Abnormalities: Comment
text
C1704258 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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