ID

15599

Beskrivning

A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02427776

Länk

https://clinicaltrials.gov/show/NCT02427776

Nyckelord

Versioner (1)
  1. 2016-06-04 2016-06-04 -
Uppladdad den

4 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776

Engelsk

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females 18 to 50 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
Beskrivning

Episode of Disease | Relapse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0035020
multiple sclerosis that meets the 2010 revised mcdonald criteria
Beskrivning

Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
Beskrivning

Multiple Sclerosis, Relapsing-Remitting | Clinically isolated syndrome | Diagnostic Imaging | Lesion of brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C2921627
UMLS CUI [3]
C0011923
UMLS CUI [4]
C0221505
disease onset, defined as date of first symptom suggestive for multiple sclerosis, not older than 10 years
Beskrivning

Onset of illness | Multiple Sclerosis Symptom First

Datatyp

boolean

Alias
UMLS CUI [1]
C0277793
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0205435
radiologically active disease defined by at least one gadolinium-enhancing lesion on a t1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
Beskrivning

Active disease diagnosis Radiologic examination | Gadolinium-Enhancing Lesion | magnetic resonance imaging of head: T1-weighted MRI brain procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2707252
UMLS CUI [1,2]
C0043299
UMLS CUI [2]
C1333400
UMLS CUI [3,1]
C2029669
UMLS CUI [3,2]
C0412675
disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (note: other disease modifying drugs might be added at a later date, depending on the results of current investigations)
Beskrivning

Biological Response Modifier Therapy | beta-1 Interferon | glatiramer acetate | dimethyl fumarate

Datatyp

boolean

Alias
UMLS CUI [1]
C0005527
UMLS CUI [2]
C0005148
UMLS CUI [3]
C0289884
UMLS CUI [4]
C0058218
edss score <= 5.5
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
positive for the hla drb1*1501 allele
Beskrivning

HLA-DRB1*1501 antigen Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1506200
UMLS CUI [1,2]
C1446409
positive predictive test in vitro for patient's cd4+ cell reactivity to immunogenic peptide
Beskrivning

Positive Predictive Value of Diagnostic Test in vitro | Cell positive for CD4 antigen Reactivity Peptide immunogenic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514243
UMLS CUI [1,2]
C1533691
UMLS CUI [2,1]
C3251824
UMLS CUI [2,2]
C0443286
UMLS CUI [2,3]
C0030956
UMLS CUI [2,4]
C0872192
women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
Beskrivning

Childbearing Potential Age | Pregnancy test negative | Contraceptive methods | Leukapheresis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0427780
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0023416
fully informed written consent obtained
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
Beskrivning

Relapse | Intravenous steroid injection | Oral steroid therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0035020
UMLS CUI [2]
C0563322
UMLS CUI [3]
C0574135
therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
Beskrivning

Therapeutic procedure Complex Anticipated | Biological Response Modifier Therapy Change | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439855
UMLS CUI [1,3]
C3840775
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C0392747
UMLS CUI [3]
C0021083
significant coexisting systemic disease including renal insufficiency
Beskrivning

Co-morbid condition | Systemic disease | Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C1275743
UMLS CUI [2]
C0442893
UMLS CUI [3]
C1565489
positive serology for hepatitis b and c, aids and syphilis
Beskrivning

Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive AIDS | Serology positive Syphilis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242089
UMLS CUI [1,2]
C0019163
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019196
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0001175
UMLS CUI [4,1]
C0242089
UMLS CUI [4,2]
C0039128
participation in another interventional clinical study, currently or during the past three months
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males and females 18 to 50 years of age
boolean
C0001779 (UMLS CUI [1])
Episode of Disease | Relapse
Item
patients closely followed up for at least one year prior to inclusion (i.e. prior to the start of the baseline phase) if the diagnosis of the disease was made more than one year ago, to ensure that all possible episodes of clinical relapses which occurred during this interval of time were recorded and documented
boolean
C0332189 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2])
Multiple Sclerosis
Item
multiple sclerosis that meets the 2010 revised mcdonald criteria
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting | Clinically isolated syndrome | Diagnostic Imaging | Lesion of brain
Item
relapsing/remitting type of multiple sclerosis (which includes clinically isolated syndromes if imaging shows brain lesions disseminated in space and time)
boolean
C0751967 (UMLS CUI [1])
C2921627 (UMLS CUI [2])
C0011923 (UMLS CUI [3])
C0221505 (UMLS CUI [4])
Onset of illness | Multiple Sclerosis Symptom First
Item
disease onset, defined as date of first symptom suggestive for multiple sclerosis, not older than 10 years
boolean
C0277793 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Active disease diagnosis Radiologic examination | Gadolinium-Enhancing Lesion | magnetic resonance imaging of head: T1-weighted MRI brain procedure
Item
radiologically active disease defined by at least one gadolinium-enhancing lesion on a t1-weighted magnetic resonance imaging brain scan performed recently (i.e. within 3 months prior to inclusion)
boolean
C2707252 (UMLS CUI [1,1])
C0043299 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2])
C2029669 (UMLS CUI [3,1])
C0412675 (UMLS CUI [3,2])
Biological Response Modifier Therapy | beta-1 Interferon | glatiramer acetate | dimethyl fumarate
Item
disease-modifying drug naïve patients or patients with stable and adequately taken disease-modifying therapy (interferon β-1, glatiramer acetate, or dimethyl fumarate) for at least six months before inclusion (note: other disease modifying drugs might be added at a later date, depending on the results of current investigations)
boolean
C0005527 (UMLS CUI [1])
C0005148 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C0058218 (UMLS CUI [4])
Kurtzke multiple sclerosis rating scale
Item
edss score <= 5.5
boolean
C0451246 (UMLS CUI [1])
HLA-DRB1*1501 antigen Positive
Item
positive for the hla drb1*1501 allele
boolean
C1506200 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Positive Predictive Value of Diagnostic Test in vitro | Cell positive for CD4 antigen Reactivity Peptide immunogenic
Item
positive predictive test in vitro for patient's cd4+ cell reactivity to immunogenic peptide
boolean
C1514243 (UMLS CUI [1,1])
C1533691 (UMLS CUI [1,2])
C3251824 (UMLS CUI [2,1])
C0443286 (UMLS CUI [2,2])
C0030956 (UMLS CUI [2,3])
C0872192 (UMLS CUI [2,4])
Childbearing Potential Age | Pregnancy test negative | Contraceptive methods | Leukapheresis
Item
women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment and follow-up phase of the study (three pregnancy tests will be required prior to and during the study: (1) during the screening phase, (2) about one week prior to leukapheresis, and (3) about one week prior to re-infusion of autologous cells)
boolean
C3831118 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0427780 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0023416 (UMLS CUI [4])
Informed consent
Item
fully informed written consent obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Relapse | Intravenous steroid injection | Oral steroid therapy
Item
evidence of clinical relapse and use of intravenous or oral corticosteroids within 30 days prior to inclusion
boolean
C0035020 (UMLS CUI [1])
C0563322 (UMLS CUI [2])
C0574135 (UMLS CUI [3])
Therapeutic procedure Complex Anticipated | Biological Response Modifier Therapy Change | Immunotherapy
Item
therapeutic escalation anticipated (including change of disease modifying drug), other than the cell-based immunotherapy of this study, within the next six months
boolean
C0087111 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C3840775 (UMLS CUI [1,3])
C0005527 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3])
Co-morbid condition | Systemic disease | Renal Insufficiency
Item
significant coexisting systemic disease including renal insufficiency
boolean
C1275743 (UMLS CUI [1])
C0442893 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive AIDS | Serology positive Syphilis
Item
positive serology for hepatitis b and c, aids and syphilis
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0001175 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0039128 (UMLS CUI [4,2])
Study Subject Participation Status
Item
participation in another interventional clinical study, currently or during the past three months
boolean
C2348568 (UMLS CUI [1])
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