ID

36221

Descrizione

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02277444

collegamento

https://clinicaltrials.gov/show/NCT02277444

Keywords

  1. 23/04/19 23/04/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

23 aprile 2019

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Juvenile Idiopathic Arthritis NCT02277444

Eligibility Juvenile Idiopathic Arthritis NCT02277444

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis must be made per juvenile idiopathic arthritis (jia) international league of associations for rheumatology (ilar) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
Descrizione

Juvenile arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3495559
failure or inadequate response to at least a 3 month course of methotrexate (mtx) before screening
Descrizione

Methotrexate failed | Methotrexate Response Inadequate

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C1704632
UMLS CUI [2,3]
C0205412
participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at week 0 as defined by american college of rheumatology (acr) criteria
Descrizione

Joints Quantity Arthritis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0003864
participants must have a screening c-reactive protein (crp) of >=0.1 milligram (mg)/deciliter (dl)
Descrizione

C-reactive protein measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201657
participants must have active jia despite current use of oral, intramuscular or subcutaneous mtx (for >=3 months before screening and on a stable dose for 4 weeks) at a weekly dose of >=10 mg/meter (m)^2. participants currently on mtx (weekly 10 to 30 mg/m^2), must receive a stable dose of mtx for >=4 weeks before screening. participants with body surface area (bsa) >=1.67 m^2 must receive a minimum of 15 mg/week of mtx unless documented country or site regulations prohibit use of 15 mg of mtx per week in participants with bsa >=1.67 m^2. in situations where there is documented intolerance of doses greater than (>) 10 mg/m^2 weekly or 15 mg/week for participants with bsa >=1.67 m^2, participants may be entered into the trial on a lower dose of mtx
Descrizione

Juvenile arthritis | Methotrexate Oral | Methotrexate Intramuscular | Methotrexate Subcutaneous | Methotrexate Dose Stable U/week | Relationship Body Surface Area

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3495559
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0025677
UMLS CUI [3,2]
C1556154
UMLS CUI [4,1]
C0025677
UMLS CUI [4,2]
C1522438
UMLS CUI [5,1]
C0025677
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [5,4]
C0560588
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0005902
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has initiated disease-modifying antirheumatic drugs (dmards) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
Descrizione

Antirheumatic Drugs, Disease-Modifying | Therapeutic immunosuppression

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0021079
participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
Descrizione

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Corticotropin Intramuscular

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
UMLS CUI [4,1]
C0001655
UMLS CUI [4,2]
C1556154
participant has been treated with any therapeutic agent targeted at reducing interleukin (il)-12 or il 23, including but not limited to ustekinumab and abt-874
Descrizione

Pharmaceutical Preparations Reducing Interleukin-12 | Pharmaceutical Preparations Reducing Interleukin-23 | ustekinumab | ABT-874

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0123759
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C0963088
UMLS CUI [3]
C1608841
UMLS CUI [4]
C2604734
participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete b or t cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
Descrizione

natalizumab | efalizumab | Pharmaceutical Preparations Reducing B-Lymphocytes | Pharmaceutical Preparations Reducing T-Lymphocyte | rituximab | alemtuzumab | visilizumab

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1172734
UMLS CUI [2]
C1174995
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392756
UMLS CUI [3,3]
C0004561
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392756
UMLS CUI [4,3]
C0039194
UMLS CUI [5]
C0393022
UMLS CUI [6]
C0383429
UMLS CUI [7]
C3887822
participant has been treated with alefacept within 3 months before first study agent administration
Descrizione

alefacept

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0962603

Similar models

Eligibility Juvenile Idiopathic Arthritis NCT02277444

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Juvenile arthritis
Item
diagnosis must be made per juvenile idiopathic arthritis (jia) international league of associations for rheumatology (ilar) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
boolean
C3495559 (UMLS CUI [1])
Methotrexate failed | Methotrexate Response Inadequate
Item
failure or inadequate response to at least a 3 month course of methotrexate (mtx) before screening
boolean
C0025677 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Joints Quantity Arthritis
Item
participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at week 0 as defined by american college of rheumatology (acr) criteria
boolean
C0022417 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
C-reactive protein measurement
Item
participants must have a screening c-reactive protein (crp) of >=0.1 milligram (mg)/deciliter (dl)
boolean
C0201657 (UMLS CUI [1])
Juvenile arthritis | Methotrexate Oral | Methotrexate Intramuscular | Methotrexate Subcutaneous | Methotrexate Dose Stable U/week | Relationship Body Surface Area
Item
participants must have active jia despite current use of oral, intramuscular or subcutaneous mtx (for >=3 months before screening and on a stable dose for 4 weeks) at a weekly dose of >=10 mg/meter (m)^2. participants currently on mtx (weekly 10 to 30 mg/m^2), must receive a stable dose of mtx for >=4 weeks before screening. participants with body surface area (bsa) >=1.67 m^2 must receive a minimum of 15 mg/week of mtx unless documented country or site regulations prohibit use of 15 mg of mtx per week in participants with bsa >=1.67 m^2. in situations where there is documented intolerance of doses greater than (>) 10 mg/m^2 weekly or 15 mg/week for participants with bsa >=1.67 m^2, participants may be entered into the trial on a lower dose of mtx
boolean
C3495559 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C0025677 (UMLS CUI [4,1])
C1522438 (UMLS CUI [4,2])
C0025677 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0560588 (UMLS CUI [5,4])
C0439849 (UMLS CUI [6,1])
C0005902 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Antirheumatic Drugs, Disease-Modifying | Therapeutic immunosuppression
Item
participant has initiated disease-modifying antirheumatic drugs (dmards) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
boolean
C0242708 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Corticotropin Intramuscular
Item
participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001655 (UMLS CUI [4,1])
C1556154 (UMLS CUI [4,2])
Pharmaceutical Preparations Reducing Interleukin-12 | Pharmaceutical Preparations Reducing Interleukin-23 | ustekinumab | ABT-874
Item
participant has been treated with any therapeutic agent targeted at reducing interleukin (il)-12 or il 23, including but not limited to ustekinumab and abt-874
boolean
C0013227 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0123759 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0963088 (UMLS CUI [2,3])
C1608841 (UMLS CUI [3])
C2604734 (UMLS CUI [4])
natalizumab | efalizumab | Pharmaceutical Preparations Reducing B-Lymphocytes | Pharmaceutical Preparations Reducing T-Lymphocyte | rituximab | alemtuzumab | visilizumab
Item
participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete b or t cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
boolean
C1172734 (UMLS CUI [1])
C1174995 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
C0004561 (UMLS CUI [3,3])
C0013227 (UMLS CUI [4,1])
C0392756 (UMLS CUI [4,2])
C0039194 (UMLS CUI [4,3])
C0393022 (UMLS CUI [5])
C0383429 (UMLS CUI [6])
C3887822 (UMLS CUI [7])
alefacept
Item
participant has been treated with alefacept within 3 months before first study agent administration
boolean
C0962603 (UMLS CUI [1])

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