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ID

36221

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02277444

Stichworte

Versionen (1)
  1. 23.04.19 23.04.19 -
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See clinicaltrials.gov

Hochgeladen am

23. April 2019

DOI

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Creative Commons BY 4.0
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    Eligibility Juvenile Idiopathic Arthritis NCT02277444

    Englisch

    Eligibility Juvenile Idiopathic Arthritis NCT02277444

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    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
    Beschreibung

    Juvenile arthritis

    Datentyp

    boolean

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

    Methotrexate failed | Methotrexate Response Inadequate

    Datentyp

    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
    Beschreibung

    Joints Quantity Arthritis

    Datentyp

    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)
    Beschreibung

    C-reactive protein measurement

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    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
    Beschreibung

    Antirheumatic Drugs, Disease-Modifying | Therapeutic immunosuppression

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    alefacept

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0962603
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Juvenile Idiopathic Arthritis NCT02277444

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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