ID

34558

Description

A Study of LY2127399 in Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01576549

Link

https://clinicaltrials.gov/show/NCT01576549

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01576549

Eligibility Rheumatoid Arthritis NCT01576549

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of adult onset ra disease according to revised 1987 american rheumatism association (ara) criteria who are currently or have a documented history of positive for rheumatoid factor (rf) and/or anti-cyclic citrullinated peptide antibody (anti-ccp ab) and who have moderately to severely active ra despite ongoing methotrexate (mtx) therapy
Description

ID.1

Data type

boolean

have active ra defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms
Description

ID.2

Data type

boolean

have a screening c-reactive protein (crp) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (esr) greater than 28 mm/hr
Description

ID.3

Data type

boolean

have a clinically inflamed joint suitable for synovial biopsy procedure
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used an unstable dose of non-steroidal anti-inflammatory drugs (nsaids) within 6 weeks prior to baseline
Description

ID.5

Data type

boolean

have used oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent within 6 weeks prior to baseline
Description

ID.6

Data type

boolean

have received any parenteral corticosteroid injection within 6 weeks of baseline
Description

ID.7

Data type

boolean

have used other disease-modifying anti-rheumatic drugs (dmards) other than mtx, hydroxychloroquine and/or sulfasalazine in the 8 weeks prior to baseline
Description

ID.8

Data type

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT01576549

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of adult onset ra disease according to revised 1987 american rheumatism association (ara) criteria who are currently or have a documented history of positive for rheumatoid factor (rf) and/or anti-cyclic citrullinated peptide antibody (anti-ccp ab) and who have moderately to severely active ra despite ongoing methotrexate (mtx) therapy
boolean
ID.2
Item
have active ra defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms
boolean
ID.3
Item
have a screening c-reactive protein (crp) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (esr) greater than 28 mm/hr
boolean
ID.4
Item
have a clinically inflamed joint suitable for synovial biopsy procedure
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
have used an unstable dose of non-steroidal anti-inflammatory drugs (nsaids) within 6 weeks prior to baseline
boolean
ID.6
Item
have used oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent within 6 weeks prior to baseline
boolean
ID.7
Item
have received any parenteral corticosteroid injection within 6 weeks of baseline
boolean
ID.8
Item
have used other disease-modifying anti-rheumatic drugs (dmards) other than mtx, hydroxychloroquine and/or sulfasalazine in the 8 weeks prior to baseline
boolean

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