Informationen:
Fehler:
ID
42332
Beschreibung
Safety Study of AMG 557 in Subjects With Lupus Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01683695
Link
https://clinicaltrials.gov/show/NCT01683695
Stichworte
Versionen (4)
- 17.01.19 17.01.19 -
- 28.05.21 28.05.21 -
- 11.06.21 11.06.21 -
- 15.06.21 15.06.21 -
Rechteinhaber
Amgen
Hochgeladen am
15. Juni 2021
DOI
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Lizenz
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
Ähnliche Modelle
Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Systemic lupus erythematosus, American college of rheumatology criteria, duration
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])
C0449238 (UMLS CUI [1,3])
C3273740 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Lupus erythematosus secondary inflammatory arthritis | quantity joint tenderness | quantity joint swelling | 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
C0409974 (UMLS CUI [1,1])
C0409703 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C0240094 (UMLS CUI [2,2])
C1265611 (UMLS CUI [3,1])
C0152031 (UMLS CUI [3,2])
C0451528 (UMLS CUI [4])
C0409703 (UMLS CUI [1,2])
C1265611 (UMLS CUI [2,1])
C0240094 (UMLS CUI [2,2])
C1265611 (UMLS CUI [3,1])
C0152031 (UMLS CUI [3,2])
C0451528 (UMLS CUI [4])
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])
C0012634 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0024141 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
C0012634 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0024141 (UMLS CUI [2,1])
C0004936 (UMLS CUI [2,2])
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])
Contraceptive methods unwilling during clinical trial period
Item
men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0558080 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])