ID

36958

Description

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01989468

Link

https://clinicaltrials.gov/show/NCT01989468

Keywords

Versions (1)
  1. 6/24/19 6/24/19 -
Copyright Holder

See clinicaltrials.gov

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June 24, 2019

DOI

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License

Creative Commons BY 4.0
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    Eligibility Psoriatic Arthritis NCT01989468

    English

    Eligibility Psoriatic Arthritis NCT01989468

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of psoriatic arthritis (psa) classified by classification criteria for psoriatic arthritis (caspar) criteria.
    Description

    Psoriatic Arthritis Classification Criteria

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003872
    UMLS CUI [1,2]
    C0008902
    UMLS CUI [1,3]
    C0243161
    rheumatoid factor and anti-cyclic citrullinated peptide (ccp) antibodies negative.
    Description

    Rheumatoid Factor Negative | Anti-Cyclic Citrullinated Protein Antibodies Negative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035448
    UMLS CUI [1,2]
    C1513916
    UMLS CUI [2,1]
    C4318437
    UMLS CUI [2,2]
    C1513916
    diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
    Description

    Psoriatic plaque | Nail changes Consistent with Psoriasis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0920235
    UMLS CUI [2,1]
    C0234909
    UMLS CUI [2,2]
    C0332290
    UMLS CUI [2,3]
    C0033860
    inadequate control of symptoms with nsaid.
    Description

    Symptom control Inadequate | Anti-Inflammatory Agents, Non-Steroidal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1274136
    UMLS CUI [1,2]
    C0205412
    UMLS CUI [2]
    C0003211
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    chest x-ray or chest magnetic resonance imaging (mri) with evidence of ongoing infectious or malignant process.
    Description

    INFECTIOUS PROCESS Chest X-ray | INFECTIOUS PROCESS MRI of Chest | Process Malignant Chest X-ray | Process Malignant MRI of Chest

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0745283
    UMLS CUI [1,2]
    C0039985
    UMLS CUI [2,1]
    C0745283
    UMLS CUI [2,2]
    C0202826
    UMLS CUI [3,1]
    C4521054
    UMLS CUI [3,2]
    C0205282
    UMLS CUI [3,3]
    C0039985
    UMLS CUI [4,1]
    C4521054
    UMLS CUI [4,2]
    C0205282
    UMLS CUI [4,3]
    C0202826
    subjects taking high potency opioid analgesics.
    Description

    Opioid Analgesics Potency High

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002772
    UMLS CUI [1,2]
    C0678792
    UMLS CUI [1,3]
    C0205250
    previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (il-17) or il-17 receptor.
    Description

    Exposure to Secukinumab | Biological agents Targeting Interleukin-17 | Biological agents Targeting Interleukin-17 receptor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332157
    UMLS CUI [1,2]
    C3179547
    UMLS CUI [2,1]
    C0005515
    UMLS CUI [2,2]
    C1521840
    UMLS CUI [2,3]
    C0384648
    UMLS CUI [3,1]
    C0005515
    UMLS CUI [3,2]
    C1521840
    UMLS CUI [3,3]
    C0669930
    ongoing use of prohibited psoriasis treatments / medications.
    Description

    Psoriasis treatment Illicit | ANTIPSORIATICS Illicit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3258078
    UMLS CUI [1,2]
    C0332266
    UMLS CUI [2,1]
    C1874314
    UMLS CUI [2,2]
    C0332266
    subjects who have ever received biologic immunomodulating agents except for those targeting tnfα.
    Description

    Biological Response Modifiers | Exception Biological Response Modifiers Targeting TNF-alpha

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005525
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0005525
    UMLS CUI [2,3]
    C1521840
    UMLS CUI [2,4]
    C1456820
    previous treatment with any cell-depleting therapies.
    Description

    T-cell depletion therapy | B-cell depletion therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677960
    UMLS CUI [2]
    C1171324
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    Similar models

    Eligibility Psoriatic Arthritis NCT01989468

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Psoriatic Arthritis Classification Criteria
    Item
    diagnosis of psoriatic arthritis (psa) classified by classification criteria for psoriatic arthritis (caspar) criteria.
    boolean
    C0003872 (UMLS CUI [1,1])
    C0008902 (UMLS CUI [1,2])
    C0243161 (UMLS CUI [1,3])
    Rheumatoid Factor Negative | Anti-Cyclic Citrullinated Protein Antibodies Negative
    Item
    rheumatoid factor and anti-cyclic citrullinated peptide (ccp) antibodies negative.
    boolean
    C0035448 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    C4318437 (UMLS CUI [2,1])
    C1513916 (UMLS CUI [2,2])
    Psoriatic plaque | Nail changes Consistent with Psoriasis
    Item
    diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
    boolean
    C0920235 (UMLS CUI [1])
    C0234909 (UMLS CUI [2,1])
    C0332290 (UMLS CUI [2,2])
    C0033860 (UMLS CUI [2,3])
    Symptom control Inadequate | Anti-Inflammatory Agents, Non-Steroidal
    Item
    inadequate control of symptoms with nsaid.
    boolean
    C1274136 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0003211 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    INFECTIOUS PROCESS Chest X-ray | INFECTIOUS PROCESS MRI of Chest | Process Malignant Chest X-ray | Process Malignant MRI of Chest
    Item
    chest x-ray or chest magnetic resonance imaging (mri) with evidence of ongoing infectious or malignant process.
    boolean
    C0745283 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    C0745283 (UMLS CUI [2,1])
    C0202826 (UMLS CUI [2,2])
    C4521054 (UMLS CUI [3,1])
    C0205282 (UMLS CUI [3,2])
    C0039985 (UMLS CUI [3,3])
    C4521054 (UMLS CUI [4,1])
    C0205282 (UMLS CUI [4,2])
    C0202826 (UMLS CUI [4,3])
    Opioid Analgesics Potency High
    Item
    subjects taking high potency opioid analgesics.
    boolean
    C0002772 (UMLS CUI [1,1])
    C0678792 (UMLS CUI [1,2])
    C0205250 (UMLS CUI [1,3])
    Exposure to Secukinumab | Biological agents Targeting Interleukin-17 | Biological agents Targeting Interleukin-17 receptor
    Item
    previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (il-17) or il-17 receptor.
    boolean
    C0332157 (UMLS CUI [1,1])
    C3179547 (UMLS CUI [1,2])
    C0005515 (UMLS CUI [2,1])
    C1521840 (UMLS CUI [2,2])
    C0384648 (UMLS CUI [2,3])
    C0005515 (UMLS CUI [3,1])
    C1521840 (UMLS CUI [3,2])
    C0669930 (UMLS CUI [3,3])
    Psoriasis treatment Illicit | ANTIPSORIATICS Illicit
    Item
    ongoing use of prohibited psoriasis treatments / medications.
    boolean
    C3258078 (UMLS CUI [1,1])
    C0332266 (UMLS CUI [1,2])
    C1874314 (UMLS CUI [2,1])
    C0332266 (UMLS CUI [2,2])
    Biological Response Modifiers | Exception Biological Response Modifiers Targeting TNF-alpha
    Item
    subjects who have ever received biologic immunomodulating agents except for those targeting tnfα.
    boolean
    C0005525 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0005525 (UMLS CUI [2,2])
    C1521840 (UMLS CUI [2,3])
    C1456820 (UMLS CUI [2,4])
    T-cell depletion therapy | B-cell depletion therapy
    Item
    previous treatment with any cell-depleting therapies.
    boolean
    C0677960 (UMLS CUI [1])
    C1171324 (UMLS CUI [2])
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