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

Link

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

Keywords

  1. 5/27/16 5/27/16 -
  2. 5/27/16 5/27/16 -
  3. 5/27/16 5/27/16 -
  4. 5/27/16 5/27/16 -
  5. 5/30/16 5/30/16 - Julian Varghese
  6. 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 Patient Information Background Information NCT02325440

ToFingo Screening V1 Patient Information Background Information NCT02325440

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
Patient information
Description

Patient information

Alias
UMLS CUI-1
C1955348
Last name
Description

Last name

Data type

text

Alias
UMLS CUI [1]
C0421448
First name
Description

First name

Data type

text

Alias
UMLS CUI [1]
C1443235
Sex
Description

Sex

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Date of birth
Description

Date of birth

Data type

date

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

Screening failure

Data type

boolean

Alias
UMLS CUI [1]
C1512714
Specify reason
Description

Specify reason

Data type

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)

Data type

boolean

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

Date of Informed consent (Study)

Data type

date

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

Informed consent lumbal puncture (optional)

Data type

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

Data type

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

Data type

boolean

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

Exclusion criteria: Patient meets any exclusion criteria

Data type

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

Data type

text

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

Date of Diagnosis/Surgery

Data type

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

Data type

date

Alias
UMLS CUI [1]
C2316983
Comments
Description

Comments

Data type

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

Data type

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

Data type

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

Data type

boolean

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

if yes, please specify

Data type

text

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

if other, please specify

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

ToFingo Screening V1 Patient Information Background Information NCT02325440

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
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])
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])

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