ID

31837

Descripción

Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00545454

Link

https://clinicaltrials.gov/show/NCT00545454

Palabras clave

Versiones (1)
  1. 1/10/18 1/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00545454

Inglés

Eligibility Rheumatoid Arthritis NCT00545454

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
either treatment-naïve patients, or those who have discontinued their rheumatoid arthritis-directed medication due to intolerability or insufficient efficacy
Descripción

Therapy naive | Rheumatoid Arthritis Pharmaceutical Preparations Discontinued | Etiology Intolerance to substance | Etiology Drug efficacy Insufficient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1744706
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0598333
UMLS CUI [4,3]
C0231180
at least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
Descripción

Tender joint count | Swollen joint count | Morning stiffness Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2]
C0451521
UMLS CUI [3,1]
C0457086
UMLS CUI [3,2]
C0449238
c-reactive protein >=1.8 mg/dl confirmed during screening period
Descripción

C-reactive protein measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201657
non-poor cytochrome p2d6 metabolizer status
Descripción

CYP2D6 poor metaboliser status Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3888904
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
functional rheumatoid arthritis class iv
Descripción

Rheumatoid Arthritis Functional Status Class

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
fever
Descripción

Fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
infections with hepatitis b, or c, or hiv
Descripción

Hepatitis B | Hepatitis C | HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
presence or history (<5 years) of cancer
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
manifest or latent tuberculosis
Descripción

Tuberculosis Manifest | Latent Tuberculosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0205319
UMLS CUI [2]
C1609538
functional abnormalities (including laboratory values) judged as clinically relevant
Descripción

Abnormality Functional | Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205245
UMLS CUI [2]
C0438215
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descripción

Study Subject Participation Status | Consideration Additional

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT00545454

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive | Rheumatoid Arthritis Pharmaceutical Preparations Discontinued | Etiology Intolerance to substance | Etiology Drug efficacy Insufficient
Item
either treatment-naïve patients, or those who have discontinued their rheumatoid arthritis-directed medication due to intolerability or insufficient efficacy
boolean
C0919936 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C1744706 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0598333 (UMLS CUI [4,2])
C0231180 (UMLS CUI [4,3])
Tender joint count | Swollen joint count | Morning stiffness Duration
Item
at least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
boolean
C0451530 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0457086 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C-reactive protein measurement
Item
c-reactive protein >=1.8 mg/dl confirmed during screening period
boolean
C0201657 (UMLS CUI [1])
CYP2D6 poor metaboliser status Absent
Item
non-poor cytochrome p2d6 metabolizer status
boolean
C3888904 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Rheumatoid Arthritis Functional Status Class
Item
functional rheumatoid arthritis class iv
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Fever
Item
fever
boolean
C0015967 (UMLS CUI [1])
Hepatitis B | Hepatitis C | HIV Infection
Item
infections with hepatitis b, or c, or hiv
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Malignant Neoplasms
Item
presence or history (<5 years) of cancer
boolean
C0006826 (UMLS CUI [1])
Tuberculosis Manifest | Latent Tuberculosis
Item
manifest or latent tuberculosis
boolean
C0041296 (UMLS CUI [1,1])
C0205319 (UMLS CUI [1,2])
C1609538 (UMLS CUI [2])
Abnormality Functional | Laboratory test result abnormal
Item
functional abnormalities (including laboratory values) judged as clinically relevant
boolean
C1704258 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Study Subject Participation Status | Consideration Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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