ID

21993

Descripción

Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b; ODM derived from: https://clinicaltrials.gov/show/NCT00942591

Link

https://clinicaltrials.gov/show/NCT00942591

Palabras clave

Versiones (1)
  1. 13/5/17 13/5/17 -
Subido en

13 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00942591

Inglés

Eligibility Multiple Sclerosis NCT00942591

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with relapsing-remitting forms of multiple sclerosis (according to mcdonald's criteria)
Descripción

Relapsing-Remitting Multiple Sclerosis Subtypes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0872379
at least 1 relapse in the past two year
Descripción

Relapse Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
> 3 lesions on spinal or brain-mri
Descripción

Lesion Quantity MRI of Spinal Cord | Lesion Quantity MRI brain procedure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C2454646
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0412675
edss score between 0 and 3.5, inclusive
Descripción

Kurtzke multiple sclerosis rating scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451246
age between 18 and 55 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
negative pregnancy test results (all women)
Descripción

Gender Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
Descripción

Disease Explanation Signs and Symptoms | Multiple Sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C0037088
UMLS CUI [2]
C0026769
primary progressive ms
Descripción

Multiple Sclerosis, Primary Progressive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751964
secondary progressive ms
Descripción

Multiple Sclerosis, Secondary Progressive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751965
uncontrolled severe medical disorder
Descripción

Disease Severe Uncontrolled

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
a history of drug abuse in the 6 months prior to screening
Descripción

Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
previous therapy with monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (except steroids)
Descripción

Monoclonal Antibody Therapy | Mitoxantrone | Cytotoxic therapy | Therapeutic immunosuppression | Steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279694
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0677881
UMLS CUI [4]
C0021079
UMLS CUI [5]
C0038317
participation in any other studies
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Multiple Sclerosis NCT00942591

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Relapsing-Remitting Multiple Sclerosis Subtypes
Item
patients with relapsing-remitting forms of multiple sclerosis (according to mcdonald's criteria)
boolean
C0751967 (UMLS CUI [1,1])
C0872379 (UMLS CUI [1,2])
Relapse Quantity
Item
at least 1 relapse in the past two year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Lesion Quantity MRI of Spinal Cord | Lesion Quantity MRI brain procedure
Item
> 3 lesions on spinal or brain-mri
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2454646 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0412675 (UMLS CUI [2,3])
Kurtzke multiple sclerosis rating scale
Item
edss score between 0 and 3.5, inclusive
boolean
C0451246 (UMLS CUI [1])
Age
Item
age between 18 and 55 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Gender Pregnancy test negative
Item
negative pregnancy test results (all women)
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Explanation Signs and Symptoms | Multiple Sclerosis
Item
any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
boolean
C0012634 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0026769 (UMLS CUI [2])
Multiple Sclerosis, Primary Progressive
Item
primary progressive ms
boolean
C0751964 (UMLS CUI [1])
Multiple Sclerosis, Secondary Progressive
Item
secondary progressive ms
boolean
C0751965 (UMLS CUI [1])
Disease Severe Uncontrolled
Item
uncontrolled severe medical disorder
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Drug abuse
Item
a history of drug abuse in the 6 months prior to screening
boolean
C0013146 (UMLS CUI [1])
Monoclonal Antibody Therapy | Mitoxantrone | Cytotoxic therapy | Therapeutic immunosuppression | Steroids
Item
previous therapy with monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (except steroids)
boolean
C0279694 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C0038317 (UMLS CUI [5])
Study Subject Participation Status
Item
participation in any other studies
boolean
C2348568 (UMLS CUI [1])
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