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])
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])