Age | Relationship Russia
Item
male or female, age between 18 and 75 years (both years inclusive), for russia only: age between 18-65 years (both years inclusive)
boolean
C0001779 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0035970 (UMLS CUI [2,2])
Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | Disease activity score DAS28 | C-reactive protein measurement | Tender 28 joint count | Swollen 28 joint count
Item
moderate to severe ra, confirmed by a disease activity score based on 28 joints and c-reactive protein (das28 (crp)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
boolean
C0003873 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [3])
C0201657 (UMLS CUI [4])
C2711398 (UMLS CUI [5])
C2711873 (UMLS CUI [6])
Methotrexate Dose unchanged U/week
Item
mtx (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Gender Childbearing Potential Absent | Postmenopausal state | Follicle stimulating hormone measurement | Female Sterilization
Item
females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (fsh) equal to or above 26.7 u/l or be surgically sterile
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0202022 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Juvenile arthritis | Arthritis, Reactive | Lyme Disease
Item
past or current inflammatory joint disease other than ra (e.g. gout [crystal proven], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or lyme disease
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C3495559 (UMLS CUI [5])
C0085435 (UMLS CUI [6])
C0024198 (UMLS CUI [7])
Chronic infectious disease | Chronic osteomyelitis | Chronic pyelonephritis
Item
any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
boolean
C0151317 (UMLS CUI [1])
C0008707 (UMLS CUI [2])
C0085697 (UMLS CUI [3])
Heart Disease | Cardiovascular Disease
Item
clinically significant cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Malignant Neoplasms
Item
past or current malignancy
boolean
C0006826 (UMLS CUI [1])
Indication Latent Tuberculosis | Indication Tuberculosis
Item
evaluation of tuberculosis screening indicative of latent or active tuberculosis (tb)
boolean
C3146298 (UMLS CUI [1,1])
C1609538 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0041296 (UMLS CUI [2,2])