ID

34391

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

  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

see on clinicaltrials.gov

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY 4.0

Model comments :

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Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

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

ID.1

Data type

boolean

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

ID.2

Data type

boolean

other inclusion criteria may apply.
Description

ID.3

Data type

boolean

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

ID.4

Data type

boolean

any disorder (including psychiatric), condition, clinically significant disease, disease activity related to sle
Description

ID.5

Data type

boolean

positive for hiv antibodies, hepatitis b surface antigen or anti-hbc, or hepatitis c antibodies
Description

ID.6

Data type

boolean

known residential exposure to an individual with tuberculosis or positive quantiferon test or ppd test at screening
Description

ID.7

Data type

boolean

men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
Description

ID.8

Data type

boolean

other exclusion criteria may apply
Description

ID.9

Data type

boolean

Similar models

Eligibility Lupus Arthritis, Systemic Lupus Erythematosus NCT01683695

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of sle for at least 6 months as defined by the most recent american college of rheumatology criteria
boolean
ID.2
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
ID.3
Item
other inclusion criteria may apply.
boolean
Item Group
C0680251 (UMLS CUI)
ID.4
Item
presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
boolean
ID.5
Item
any disorder (including psychiatric), condition, clinically significant disease, disease activity related to sle
boolean
ID.6
Item
positive for hiv antibodies, hepatitis b surface antigen or anti-hbc, or hepatitis c antibodies
boolean
ID.7
Item
known residential exposure to an individual with tuberculosis or positive quantiferon test or ppd test at screening
boolean
ID.8
Item
men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
boolean
ID.9
Item
other exclusion criteria may apply
boolean

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