Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776

1 moduli

StudyEvent: Eligibility
1. Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02427776