Rheumatoid Arthritis Duration
Item
a diagnosis of ra meeting the 2010 acr (american college of rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (if the diagnosis was made prior to 2010, a diagnosis meeting the 1987 acr classification criteria is acceptable)
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Rheumatoid Arthritis Disease activity score DAS28 | C-reactive protein measurement | Tender 28 joint count | Swollen 28 joint count
Item
active ra characterised by das28-crp (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0201657 (UMLS CUI [2])
C2711398 (UMLS CUI [3])
C2711873 (UMLS CUI [4])
Methotrexate Dose Stable
Item
concomitant treatment with mtx above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (mtx doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Biological agents Absent | Biological agents Rheumatoid Arthritis | Criteria Fulfill | Intolerance to Biological agents | Biological agents Discontinued | Etiology Except Lack of Efficacy
Item
biologic naïve subjects or subjects having been treated with biologics for ra (biologic experienced) provided they meet one of the following criteria: a. reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)
boolean
C0005515 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C0005515 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0332300 (UMLS CUI [6,2])
C0235828 (UMLS CUI [6,3])
Body mass index
Item
body mass index (bmi) below or equal to 18.0 or above or equal to 38.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis | Involvement Systemic Secondary to Rheumatoid Arthritis | Vasculitis | Pulmonary Fibrosis | Felty Syndrome | Sjogren's Syndrome Secondary Eligible | Hypothyroidism Stable Eligible
Item
subjects with rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra (including but not limited to vasculitis, pulmonary fibrosis, or felty's syndrome). subjects with secondary sjögren's syndrome or stable hypothyroidism are eligible
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
C0003873 (UMLS CUI [3,4])
C0042384 (UMLS CUI [4])
C0034069 (UMLS CUI [5])
C0015773 (UMLS CUI [6])
C1527336 (UMLS CUI [7,1])
C0175668 (UMLS CUI [7,2])
C1548635 (UMLS CUI [7,3])
C0020676 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C1548635 (UMLS CUI [8,3])
Bacterial Infections | Exception resolved | Urinary tract infection Simple
Item
any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0042029 (UMLS CUI [3,1])
C0205352 (UMLS CUI [3,2])
Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
boolean
C0239998 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0231203 (UMLS CUI [2,2])
C0151317 (UMLS CUI [2,3])
C0006267 (UMLS CUI [3])
C0008707 (UMLS CUI [4])
Systemic mycosis Severe | Exception resolved
Item
history of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy
boolean
C0553576 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])