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
Versions (6)
- 5/27/16 5/27/16 -
- 5/27/16 5/27/16 -
- 5/27/16 5/27/16 -
- 5/27/16 5/27/16 -
- 5/30/16 5/30/16 - Julian Varghese
- 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
Description
Patient information
Alias
- UMLS CUI-1
- C1955348
Description
Last name
Data type
text
Alias
- UMLS CUI [1]
- C0421448
Description
First name
Data type
text
Alias
- UMLS CUI [1]
- C1443235
Description
Sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Screening failure
Data type
boolean
Alias
- UMLS CUI [1]
- C1512714
Description
Specify reason
Data type
text
Alias
- UMLS CUI [1,1]
- C1512714
- UMLS CUI [1,2]
- C0566251
Description
Informed consent
Alias
- UMLS CUI-1
- C0021430
Description
Informed consent (Study)
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Date of Informed consent (Study)
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
Informed consent lumbal puncture (optional)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
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
Description
Inclusion/Exclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C0680251
Description
Inclusion criteria: Patient meets all inclusion criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C1302261
Description
Exclusion criteria: Patient meets any exclusion criteria
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
Relevant medical history/current medical conditions
Alias
- UMLS CUI-1
- C0262926
Description
Diagnosis/Surgery
Data type
text
Alias
- UMLS CUI [1]
- C0011900
- UMLS CUI [2]
- C0543467
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
Description
Active at start of study
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
Comments
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
MS history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026769
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
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
Description
Previous MS therapies received
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C3539076
Description
if yes, please specify
Data type
text
Alias
- UMLS CUI [1]
- C4020596
Description
if other, please specify
Data type
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])