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

Uploaded on

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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