ID

15301

Descrizione

Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses; ODM derived from: https://clinicaltrials.gov/show/NCT01487096

collegamento

https://clinicaltrials.gov/show/NCT01487096

Keywords

  1. 25/05/16 25/05/16 -
Caricato su

25 maggio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT01487096

Eligibility Multiple Sclerosis NCT01487096

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically confirmed multiple sclerosis [ms];
Descrizione

MS

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0026769
expanded disability status scale [edss] score less or equal to 6;
Descrizione

edss

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0451246
two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
Descrizione

two documented relapses

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0277556
screening magnetic resonance imaging [mri] scan fulfilling the criteria for a diagnosis of ms.
Descrizione

MRI

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0024485
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
Descrizione

comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or nursing woman;
Descrizione

pregnant or nursing woman

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
Descrizione

contraceptive use

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1999124
prior treatment with interferon [ifn], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
Descrizione

pharmaceutical preparations

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279030
UMLS CUI [2]
C0860681
UMLS CUI [3]
C0289884
UMLS CUI [4]
C1963758
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
Descrizione

immunosuppressant agents

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021081
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
Descrizione

comorbidity limiting compliance behavior

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1321605
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrizione

not intended to contain all considerations

Tipo di dati

boolean

Similar models

Eligibility Multiple Sclerosis NCT01487096

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
MS
Item
clinically confirmed multiple sclerosis [ms];
boolean
C0026769 (UMLS CUI [1])
edss
Item
expanded disability status scale [edss] score less or equal to 6;
boolean
C0451246 (UMLS CUI [1])
two documented relapses
Item
two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
boolean
C0277556 (UMLS CUI [1])
MRI
Item
screening magnetic resonance imaging [mri] scan fulfilling the criteria for a diagnosis of ms.
boolean
C0024485 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
boolean
C0009488 (UMLS CUI [1])
pregnant or nursing woman
Item
pregnant or nursing woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraceptive use
Item
wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
boolean
C1999124 (UMLS CUI [1])
pharmaceutical preparations
Item
prior treatment with interferon [ifn], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
boolean
C0279030 (UMLS CUI [1])
C0860681 (UMLS CUI [2])
C0289884 (UMLS CUI [3])
C1963758 (UMLS CUI [4])
immunosuppressant agents
Item
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
boolean
C0021081 (UMLS CUI [1])
comorbidity limiting compliance behavior
Item
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
not intended to contain all considerations
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean

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