ID

15871

Description

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA); ODM derived from: https://clinicaltrials.gov/show/NCT02319759

Link

https://clinicaltrials.gov/show/NCT02319759

Keywords

Versions (1)
  1. 6/17/16 6/17/16 -
Uploaded on

June 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis NCT02319759

English

Eligibility Psoriatic Arthritis NCT02319759

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has had psoriatic arthritis (psa) for at least 6 months before the first administration of study drug and meet classification criteria for psoriatic arthritis (caspar) at screening
Description

Arthritis, Psoriatic | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2]
C0013230
had active psa as defined by:
Description

Arthritis, Psoriatic

Data type

boolean

Alias
UMLS CUI [1]
C0003872
1. at least 3 swollen joints and at least 3 tender joints at screening and at baseline
Description

Joint swelling | Joint tenderness

Data type

boolean

Alias
UMLS CUI [1]
C0152031
UMLS CUI [2]
C0240094
2. c-reactive protein (crp) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dl) at screening from the central laboratory
Description

C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201657
has at least 1 of the psa subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Description

Arthritis, Psoriatic | Involvement with Interphalangeal joint Distal | Polyarthritis | Rheumatoid Nodule Absent | Arthritis mutilans | ARTHRITIS, PERIPHERAL Asymmetric | Spondylitis Associated with ARTHRITIS, PERIPHERAL

Data type

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C1563055
UMLS CUI [2,3]
C0205108
UMLS CUI [3]
C0162323
UMLS CUI [4,1]
C0035450
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0702102
UMLS CUI [6,1]
C0238694
UMLS CUI [6,2]
C0332514
UMLS CUI [7,1]
C0038012
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0238694
has plaque psoriasis with body surface area (bsa) involvement greater than or equal to (>=) 3% at screening and baseline
Description

Psoriasis Cutaneous plaque | Body Surface Area Involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0241148
UMLS CUI [2,1]
C0005902
UMLS CUI [2,2]
C1314939
has active psa despite current or previous non-biologic disease-modifying antirheumatic drugs (dmard), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (nsaid) therapy
Description

Arthritis, Psoriatic | Therapeutic procedure | Non-Biologic Disease-Modifying Antirheumatic Drug | Oral steroid therapy | Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2]
C0087111
UMLS CUI [3]
C4054347
UMLS CUI [4]
C0574135
UMLS CUI [5]
C0003211
if using methotrexate (mtx), oral corticosteroids or nsaids, the dose must be stable
Description

Methotrexate | Oral steroid therapy | Anti-Inflammatory Agents, Non-Steroidal | Dosage Stable

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0574135
UMLS CUI [3]
C0003211
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (ra), ankylosing spondylitis (as), systemic lupus erythematosus, or lyme disease
Description

Inflammatory disorder Interferes with Evaluation guselkumab | Rheumatoid Arthritis | Ankylosing spondylitis | Lupus Erythematosus, Systemic | Lyme Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0220825
UMLS CUI [1,4]
C3852217
UMLS CUI [2]
C0003873
UMLS CUI [3]
C0038013
UMLS CUI [4]
C0024141
UMLS CUI [5]
C0024198
has previously received guselkumab or ustekinumab
Description

guselkumab | ustekinumab

Data type

boolean

Alias
UMLS CUI [1]
C3852217
UMLS CUI [2]
C1608841
has received more than 1 type of biologic anti-tumor necrosis factor (tnf) agent previously
Description

Anti-tumor necrosis factor drug biological

Data type

boolean

Alias
UMLS CUI [1,1]
C1562242
UMLS CUI [1,2]
C0205460
have received infliximab (or its biosimilars) or golimumab intraveneous (iv) within 12 weeks before the first administration of study drug
Description

infliximab | infliximab Biosimilars | golimumab Intravenous | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2,1]
C0666743
UMLS CUI [2,2]
C4045974
UMLS CUI [3,1]
C2353893
UMLS CUI [3,2]
C1522726
UMLS CUI [4]
C0013230
have received adalimumab (or its biosimilars), golimumab subcutaneous (sc), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
Description

adalimumab | adalimumab Biosimilars | golimumab Subcutaneous | certolizumab pegol | Etanercept | Etanercept Biosimilars | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1122087
UMLS CUI [2,1]
C1122087
UMLS CUI [2,2]
C4045974
UMLS CUI [3,1]
C2353893
UMLS CUI [3,2]
C1522438
UMLS CUI [4]
C1872109
UMLS CUI [5]
C0717758
UMLS CUI [6,1]
C0717758
UMLS CUI [6,2]
C4045974
UMLS CUI [7]
C0013230
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Similar models

Eligibility Psoriatic Arthritis NCT02319759

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Arthritis, Psoriatic | Investigational New Drugs
Item
has had psoriatic arthritis (psa) for at least 6 months before the first administration of study drug and meet classification criteria for psoriatic arthritis (caspar) at screening
boolean
C0003872 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Arthritis, Psoriatic
Item
had active psa as defined by:
boolean
C0003872 (UMLS CUI [1])
Joint swelling | Joint tenderness
Item
1. at least 3 swollen joints and at least 3 tender joints at screening and at baseline
boolean
C0152031 (UMLS CUI [1])
C0240094 (UMLS CUI [2])
C-reactive protein measurement
Item
2. c-reactive protein (crp) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dl) at screening from the central laboratory
boolean
C0201657 (UMLS CUI [1])
Arthritis, Psoriatic | Involvement with Interphalangeal joint Distal | Polyarthritis | Rheumatoid Nodule Absent | Arthritis mutilans | ARTHRITIS, PERIPHERAL Asymmetric | Spondylitis Associated with ARTHRITIS, PERIPHERAL
Item
has at least 1 of the psa subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
boolean
C0003872 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C1563055 (UMLS CUI [2,2])
C0205108 (UMLS CUI [2,3])
C0162323 (UMLS CUI [3])
C0035450 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0702102 (UMLS CUI [5])
C0238694 (UMLS CUI [6,1])
C0332514 (UMLS CUI [6,2])
C0038012 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0238694 (UMLS CUI [7,3])
Psoriasis Cutaneous plaque | Body Surface Area Involvement
Item
has plaque psoriasis with body surface area (bsa) involvement greater than or equal to (>=) 3% at screening and baseline
boolean
C0033860 (UMLS CUI [1,1])
C0241148 (UMLS CUI [1,2])
C0005902 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
Arthritis, Psoriatic | Therapeutic procedure | Non-Biologic Disease-Modifying Antirheumatic Drug | Oral steroid therapy | Anti-Inflammatory Agents, Non-Steroidal
Item
has active psa despite current or previous non-biologic disease-modifying antirheumatic drugs (dmard), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (nsaid) therapy
boolean
C0003872 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C4054347 (UMLS CUI [3])
C0574135 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
Methotrexate | Oral steroid therapy | Anti-Inflammatory Agents, Non-Steroidal | Dosage Stable
Item
if using methotrexate (mtx), oral corticosteroids or nsaids, the dose must be stable
boolean
C0025677 (UMLS CUI [1])
C0574135 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0178602 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Inflammatory disorder Interferes with Evaluation guselkumab | Rheumatoid Arthritis | Ankylosing spondylitis | Lupus Erythematosus, Systemic | Lyme Disease
Item
have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (ra), ankylosing spondylitis (as), systemic lupus erythematosus, or lyme disease
boolean
C1290884 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C3852217 (UMLS CUI [1,4])
C0003873 (UMLS CUI [2])
C0038013 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0024198 (UMLS CUI [5])
guselkumab | ustekinumab
Item
has previously received guselkumab or ustekinumab
boolean
C3852217 (UMLS CUI [1])
C1608841 (UMLS CUI [2])
Anti-tumor necrosis factor drug biological
Item
has received more than 1 type of biologic anti-tumor necrosis factor (tnf) agent previously
boolean
C1562242 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
infliximab | infliximab Biosimilars | golimumab Intravenous | Investigational New Drugs
Item
have received infliximab (or its biosimilars) or golimumab intraveneous (iv) within 12 weeks before the first administration of study drug
boolean
C0666743 (UMLS CUI [1])
C0666743 (UMLS CUI [2,1])
C4045974 (UMLS CUI [2,2])
C2353893 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4])
adalimumab | adalimumab Biosimilars | golimumab Subcutaneous | certolizumab pegol | Etanercept | Etanercept Biosimilars | Investigational New Drugs
Item
have received adalimumab (or its biosimilars), golimumab subcutaneous (sc), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug
boolean
C1122087 (UMLS CUI [1])
C1122087 (UMLS CUI [2,1])
C4045974 (UMLS CUI [2,2])
C2353893 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
C1872109 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
C0717758 (UMLS CUI [6,1])
C4045974 (UMLS CUI [6,2])
C0013230 (UMLS CUI [7])
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