ID

40510

Description

A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS); ODM derived from: https://clinicaltrials.gov/show/NCT01230827

Link

https://clinicaltrials.gov/show/NCT01230827

Keywords

Versions (1)
  1. 4/28/20 4/28/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 28, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT01230827

English

Eligibility Juvenile Idiopathic Arthritis NCT01230827

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis must have been before the patient's 16th birthday
Description

Diagnosis | Age

Data type

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0001779
disease duration of at least 6 months before study entry
Description

Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
must have 5 or more joints with active arthritis
Description

Arthritis Joints Count

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0750480
must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [bsa] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
Description

Methotrexate Dose Stable | Body Surface Area

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0005902
may take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of nsaids (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
Description

Prednisone Dose Stable U/day | NSAIDs Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
must have qualifying laboratory values at the first visit.
Description

Laboratory Results Qualifying

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514624
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
Description

Hypersensitivity Golimumab | Intolerance to Golimumab | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2353893
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2353893
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0035150
UMLS CUI [4,2]
C1301732
have initiated dmards and/or immunosuppressive therapy within 4 weeks prior to study initiation
Description

Initiation DMARDs | Initiation Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C0242708
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0021079
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Similar models

Eligibility Juvenile Idiopathic Arthritis NCT01230827

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis | Age
Item
diagnosis must have been before the patient's 16th birthday
boolean
C0011900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Disease length
Item
disease duration of at least 6 months before study entry
boolean
C0872146 (UMLS CUI [1])
Arthritis Joints Count
Item
must have 5 or more joints with active arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Methotrexate Dose Stable | Body Surface Area
Item
must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [bsa] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0005902 (UMLS CUI [2])
Prednisone Dose Stable U/day | NSAIDs Dose Stable
Item
may take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of nsaids (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Laboratory Results Qualifying
Item
must have qualifying laboratory values at the first visit.
boolean
C1254595 (UMLS CUI [1,1])
C1514624 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Golimumab | Intolerance to Golimumab | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar
Item
have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
boolean
C0020517 (UMLS CUI [1,1])
C2353893 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2353893 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned
Item
are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0035150 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Initiation DMARDs | Initiation Therapeutic immunosuppression
Item
have initiated dmards and/or immunosuppressive therapy within 4 weeks prior to study initiation
boolean
C1704686 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0021079 (UMLS CUI [2,2])
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