ID

42315

Description

Safety Study of AMG 557 in Subjects With Lupus Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01683695

Link

https://clinicaltrials.gov/show/NCT01683695

Keywords

Versions (4)
  1. 1/17/19 1/17/19 -
  2. 5/28/21 5/28/21 -
  3. 6/11/21 6/11/21 -
  4. 6/15/21 6/15/21 -
Copyright Holder

Amgen

Uploaded on

May 28, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

English

Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of sle for at least 6 months as defined by the most recent american college of rheumatology criteria
Description

Systemic lupus erythematosus | American college of rheumatology criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0024141
UMLS CUI [1,2]
C3273740
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;
Description

Lupus-related secondary inflammatory arthritis | tender joint count | swollen joint count | SLE disease activity index

Data type

boolean

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0409703
UMLS CUI [1,3]
C0409974
UMLS CUI [2]
C0451530
UMLS CUI [3]
C0451521
UMLS CUI [4]
C0451528
other inclusion criteria may apply.
Description

Inclusion criteria other

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205394
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
Description

Vasculitis | lupus nephritis requiring therapy

Data type

boolean

Alias
UMLS CUI [1]
C0042384
UMLS CUI [2,1]
C0024143
UMLS CUI [2,2]
C0686904
UMLS CUI [2,3]
C0087111
any disorder (including psychiatric), condition, clinically significant disease, disease activity related to sle
Description

SLE-related clinically significant disease | SLE-related mental disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0024141
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C2826293
UMLS CUI [2,1]
C0024141
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0004936
positive for hiv antibodies, hepatitis b surface antigen or anti-hbc, or hepatitis c antibodies
Description

HIV antibodies | Hepatitis b surface antigen | antibody to Hepatitis B core antigen | Hepatitis c antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0019683
UMLS CUI [2]
C0019168
UMLS CUI [3]
C0312631
UMLS CUI [4]
C0166049
known residential exposure to an individual with tuberculosis or positive quantiferon test or ppd test at screening
Description

Tuberculosis exposure household | quantiferon test positive finding | tuberculin test positive finding

Data type

boolean

Alias
UMLS CUI [1,1]
C0149796
UMLS CUI [1,2]
C0020052
UMLS CUI [2,1]
C1875713
UMLS CUI [2,2]
C1514241
UMLS CUI [3,1]
C0041290
UMLS CUI [3,2]
C1514241
men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
Description

Females and males of reproductive potential, contraceptive methods unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
other exclusion criteria may apply
Description

Exclusion criteria other

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Inclusion criteria other
Item
other inclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
Exclusion criteria other
Item
other exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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