Information:
Fel:
ID
31837
Beskrivning
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
Länk
https://clinicaltrials.gov/show/NCT00545454
Nyckelord
Versioner (1)
- 2018-10-01 2018-10-01 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
1 oktober 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00545454
Eligibility Rheumatoid Arthritis NCT00545454
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00545454
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
C0332197 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])