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Information:
Fel:
ID
42315
Beskrivning
Safety Study of AMG 557 in Subjects With Lupus Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01683695
Länk
https://clinicaltrials.gov/show/NCT01683695
Nyckelord
Versioner (4)
- 2019-01-17 2019-01-17 -
- 2021-05-28 2021-05-28 -
- 2021-06-11 2021-06-11 -
- 2021-06-15 2021-06-15 -
Rättsinnehavare
Amgen
Uppladdad den
28 maj 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695
Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695
- StudyEvent: Eligibility
Similar models
Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Systemic lupus erythematosus | American college of rheumatology criteria
Item
diagnosis of sle for at least 6 months as defined by the most recent american college of rheumatology criteria
boolean
C0024141 (UMLS CUI [1,1])
C3273740 (UMLS CUI [1,2])
C3273740 (UMLS CUI [1,2])
Lupus-related secondary inflammatory arthritis | tender joint count | swollen joint count | SLE disease activity index
Item
presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and systemic lupus erythematosus disease activity index (sledai) ≥ 6 at screening;
boolean
C0439849 (UMLS CUI [1,1])
C0409703 (UMLS CUI [1,2])
C0409974 (UMLS CUI [1,3])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C0451528 (UMLS CUI [4])
C0409703 (UMLS CUI [1,2])
C0409974 (UMLS CUI [1,3])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C0451528 (UMLS CUI [4])
Inclusion criteria other
Item
other inclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Vasculitis | lupus nephritis requiring therapy
Item
presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
boolean
C0042384 (UMLS CUI [1])
C0024143 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0024143 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
SLE-related clinically significant disease | SLE-related mental disorder
Item
any disorder (including psychiatric), condition, clinically significant disease, disease activity related to sle
boolean
C0024141 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0024141 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
C0439849 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0024141 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0004936 (UMLS CUI [2,3])
HIV antibodies | Hepatitis b surface antigen | antibody to Hepatitis B core antigen | Hepatitis c antibodies
Item
positive for hiv antibodies, hepatitis b surface antigen or anti-hbc, or hepatitis c antibodies
boolean
C0019683 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0312631 (UMLS CUI [3])
C0166049 (UMLS CUI [4])
C0019168 (UMLS CUI [2])
C0312631 (UMLS CUI [3])
C0166049 (UMLS CUI [4])
Tuberculosis exposure household | quantiferon test positive finding | tuberculin test positive finding
Item
known residential exposure to an individual with tuberculosis or positive quantiferon test or ppd test at screening
boolean
C0149796 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C1875713 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0041290 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0020052 (UMLS CUI [1,2])
C1875713 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0041290 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Females and males of reproductive potential, contraceptive methods unwilling
Item
men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Exclusion criteria other
Item
other exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])