ID

15419

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)
  1. 27/05/2016 27/05/2016 -
  2. 27/05/2016 27/05/2016 -
  3. 27/05/2016 27/05/2016 -
  4. 27/05/2016 27/05/2016 -
  5. 30/05/2016 30/05/2016 - Julian Varghese
  6. 31/05/2016 31/05/2016 -
Téléchargé le

31 mai 2016

DOI

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Licence

Creative Commons BY 4.0
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ToFingo Screening V1 Patient Information Background Information NCT02325440

Anglais

ToFingo Screening V1 Patient Information Background Information NCT02325440

1 Formulaires  
Study Administration
Description

Study Administration

Data entry for this CRF completed
Description

Data entry for this CRF completed

Type de données

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Description

Assessment date

Type de données

date

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

Current patient (ID)

Type de données

text

Alias
UMLS CUI [1]
C2348585
Patient information
Description

Patient information

Alias
UMLS CUI-1
C1955348
Last name
Description

Last name

Type de données

text

Alias
UMLS CUI [1]
C0421448
First name
Description

First name

Type de données

text

Alias
UMLS CUI [1]
C1443235
Sex
Description

Sex

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Type de données

text

Alias
UMLS CUI [1]
C0034510
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Screening failure (Patient signed Informed Consent, but failed eligibility-criteria)
Description

Screening failure

Type de données

boolean

Alias
UMLS CUI [1]
C1512714
Specify reason
Description

Specify reason

Type de données

text

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0566251
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
Informed consent (Study)
Description

Informed consent (Study)

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Date of Informed consent (Study)
Description

Date of Informed consent (Study)

Type de données

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Informed consent lumbal puncture (optional)
Description

Informed consent lumbal puncture (optional)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0037943
Date of Informed Consent lumbar puncture
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
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Inclusion criteria: Patient meets all inclusion criteria
Description

Inclusion criteria: Patient meets all inclusion criteria

Type de données

boolean

Alias
UMLS CUI [1]
C1302261
Exclusion criteria: Patient meets any exclusion criteria
Description

Exclusion criteria: Patient meets any exclusion criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
Relevant medical history/current medical conditions
Description

Relevant medical history/current medical conditions

Alias
UMLS CUI-1
C0262926
Diagnosis/Surgery
Description

Diagnosis/Surgery

Type de données

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0543467
Date of Diagnosis/Surgery
Description

Date of Diagnosis/Surgery

Type de données

date

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0011008
Active at start of study
Description

Active at start of study

Type de données

date

Alias
UMLS CUI [1]
C2316983
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611
MS history
Description

MS history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0026769
Date of confirmed MS diagnosis
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
Date of first MS symptoms
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
Previous MS therapies received
Description

Previous MS therapies received

Type de données

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C3539076
if yes, please specify
Description

if yes, please specify

Type de données

text

Alias
UMLS CUI [1]
C4020596
if other, please specify
Description

if other, please specify

Type de données

text

Alias
UMLS CUI [1]
C0947611
Retour au début de la page

Similar models

ToFingo Screening V1 Patient Information Background Information NCT02325440

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Patient information
C1955348 (UMLS CUI-1)
Last name
Item
Last name
text
C0421448 (UMLS CUI [1])
First name
Item
First name
text
C1443235 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
male (1)
CL Item
female (2)
Race
Item
Race
text
C0034510 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Screening failure
Item
Screening failure (Patient signed Informed Consent, but failed eligibility-criteria)
boolean
C1512714 (UMLS CUI [1])
Specify reason
Item
Specify reason
text
C1512714 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed consent (Study)
Item
Informed consent (Study)
boolean
C0021430 (UMLS CUI [1])
Date of Informed consent (Study)
Item
Date of Informed consent (Study)
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Informed consent lumbal puncture (optional)
Item
Informed consent lumbal puncture (optional)
boolean
C0021430 (UMLS CUI [1,1])
C0037943 (UMLS CUI [1,2])
Date of Informed Consent lumbar puncture
Item
Date of Informed Consent lumbar puncture
date
C0021430 (UMLS CUI [1,1])
C0037943 (UMLS CUI [1,2])
C0001108 (UMLS CUI [1,3])
Item Group
Inclusion/Exclusion Criteria
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
Inclusion criteria: Patient meets all inclusion criteria
Item
Inclusion criteria: Patient meets all inclusion criteria
boolean
C1302261 (UMLS CUI [1])
Exclusion criteria: Patient meets any exclusion criteria
Item
Exclusion criteria: Patient meets any exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Item Group
Relevant medical history/current medical conditions
C0262926 (UMLS CUI-1)
Diagnosis/Surgery
Item
Diagnosis/Surgery
text
C0011900 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
Date of Diagnosis/Surgery
Item
Date of Diagnosis/Surgery
date
C0011900 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Active at start of study
Item
Active at start of study
date
C2316983 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
MS history
C0262926 (UMLS CUI-1)
C0026769 (UMLS CUI-2)
Date of confirmed MS diagnosis
Item
Date of confirmed MS diagnosis
date
C0026769 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of first MS symptoms
Item
Date of first MS symptoms
date
C0026769 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Previous MS therapies received
Item
Previous MS therapies received
boolean
C0026769 (UMLS CUI [1,1])
C3539076 (UMLS CUI [1,2])
if yes, please specify
Item
if yes, please specify
text
C4020596 (UMLS CUI [1])
if other, please specify
Item
if other, please specify
text
C0947611 (UMLS CUI [1])
Retour au début de la page 

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