Adult | Age
Item
adult patients, >=18 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
moderate to severe active rheumatoid arthritis for >6 months;
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
DMARD Response Inadequate | Intolerance to DMARD
Item
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic disease-modifying antirheumatic drug (dmard) therapy;
boolean
C0242708 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0242708 (UMLS CUI [2,2])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) >/=4 and tender joint count (tjc) >/=4
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Body Weight
Item
body weight </=150kg
boolean
C0005910 (UMLS CUI [1])
DMARDs Dose Stable
Item
current permitted non-biologic dmards must be on stable dose for >/= 7 weeks prior to baseline;
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
boolean
C0004364 (UMLS CUI [1])
C0683381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
rituximab
Item
treatment with rituximab within 6 months before screening;
boolean
C0393022 (UMLS CUI [1])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous
Item
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
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])
Communicable Disease | Recurrent infections | Episode Major Communicable Disease | Hospitalization Required | Requirement Antibiotics Intravenous | Requirement Antibiotics Oral
Item
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
boolean
C0009450 (UMLS CUI [1])
C0239998 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C1708385 (UMLS CUI [4])
C1514873 (UMLS CUI [5,1])
C0003232 (UMLS CUI [5,2])
C1522726 (UMLS CUI [5,3])
C1514873 (UMLS CUI [6,1])
C0003232 (UMLS CUI [6,2])
C1527415 (UMLS CUI [6,3])