Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis Duration
Item
a diagnosis of rheumatoid arthritis made at least 3 months prior to screening
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Rheumatoid Arthritis DAS28
Item
active rheumatoid arthritis, characterised by a das28 equal or above 3.2
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Methotrexate Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Non-Steroidal Anti-Inflammatory Agents Dose Recommended | Acetaminophen Dose Recommended | Opioids Dose Recommended
Item
methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0034866 (UMLS CUI [3,3])
C0000970 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0034866 (UMLS CUI [4,3])
C0242402 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0034866 (UMLS CUI [5,3])
Male infertility | Childbearing Potential Absent
Item
male subjects and female subjects of non-child bearing potential
boolean
C0021364 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Body mass index
Item
body mass index (bmi) less than 18.5 or above 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Autoimmune Diseases inflammatory chronic | Exception Rheumatoid Arthritis
Item
subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
boolean
C0004364 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of or current inflammatory joint disease other than rheumatoid arthritis
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Chronic infectious disease | Communicable Diseases | Requirement Anti-infective therapy Systemic
Item
chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C1141958 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
Malignant Neoplasms
Item
past or current malignancy (as judged by the investigator)
boolean
C0006826 (UMLS CUI [1])
Heart Diseases | Cardiovascular Diseases
Item
clinically significant cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
HIV Seropositivity | Hepatitis | Tuberculosis
Item
positive for human immunodeficiency virus (hiv), hepatitis or tuberculosis
boolean
C0019699 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
Blood Donation Amount Timespan | Blood Loss Amount Timespan
Item
blood donation or blood loss of more than 0.45l within 2 months prior to study start, or longer if required by local regulations
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Breast Feeding
Item
breast-feeding women
boolean
C0006147 (UMLS CUI [1])