Age
Item
male and female subjects at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Disease length
Item
subject has a diagnosis of rheumatoid arthritis (ra) as defined by either the 1987-revised american college of rheumatology (acr) classification criteria or the new acr/ european league against rheumatism (eular) diagnostic criteria for ra 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Criteria Fulfill
Item
subject must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C-reactive protein Disease activity score DAS28
Item
1. disease activity score of c-reactive protein (das28[crp]) ≥ 3.2 (at the baseline visit only)
boolean
C0006560 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
Swollen joint count
Item
2. at least 6 swollen joints out of 66 assessed (at the screening and baseline visits)
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
3. at least 8 tender joints out of 68 assessed (at the screening and baseline visits)
boolean
C0451530 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
4. c-reactive protein (crp) ≥ 1.5 mg/dl (at the screening visit only), or erythrocyte sedimentation rate (esr) ≥ 28 mm/1h (at the screening and baseline visits)
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Criteria Fulfill Quantity | Rheumatoid factor positive | Bone erosion Quantity | Anti-cyclic citrullinated peptide antibody positive
Item
5. fulfill at least one of the following three criteria: rheumatoid factor (rf) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-ccp) antibody positive
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0151379 (UMLS CUI [2])
C0587240 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2609056 (UMLS CUI [4])
Study Subject Good health Medical History | Study Subject Good health Profile | Study Subject Good health Physical Examination | Study Subject Good health Chest X-ray | Study Subject Good health 12 lead ECG
Item
subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (cxr), and a 12-lead electrocardiogram (ecg) performed during screening
boolean
C0681850 (UMLS CUI [1,1])
C3813622 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C3813622 (UMLS CUI [2,2])
C1979963 (UMLS CUI [2,3])
C0681850 (UMLS CUI [3,1])
C3813622 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0681850 (UMLS CUI [4,1])
C3813622 (UMLS CUI [4,2])
C0039985 (UMLS CUI [4,3])
C0681850 (UMLS CUI [5,1])
C3813622 (UMLS CUI [5,2])
C0430456 (UMLS CUI [5,3])
Exposure to Biological treatment Systemic | adalimumab
Item
subject has previous exposure to any systemic biologic therapy including adalimumab
boolean
C0332157 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1122087 (UMLS CUI [2])
Disease-Modifying Antirheumatic Drugs Quantity | Methotrexate
Item
subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (dmards) or with methotrexate (mtx)
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2])
Operation on joint | Clinical Trial Assessment Joints
Item
subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
boolean
C0185132 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
Chronic arthritis | Age
Item
subject has chronic arthritis diagnosed before age 17 years
boolean
C0263680 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Communicable Disease Invasive | Listeriosis | Histoplasmosis | Hepatitis C, Chronic | Hepatitis C | HIV Infection | Immunologic Deficiency Syndromes | Recurrent infections chronic | Tuberculosis
Item
history of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active hepatitis c infection, human immunodeficiency virus (hiv) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (tb)
boolean
C0009450 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0023860 (UMLS CUI [2])
C0019655 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
C0021051 (UMLS CUI [7])
C0239998 (UMLS CUI [8,1])
C0205191 (UMLS CUI [8,2])
C0041296 (UMLS CUI [9])
Hepatitis B Virus | Hepatitis B surface antigen positive | Hepatitis B DNA detectable Polymerase chain reaction test
Item
hepatitis b virus: hepatitis b surface antigen (hbs ag) positive (+) or detected sensitivity on the hepatitis b virus dna (hbv dna) polymerase chain reaction (pcr) qualitative test
boolean
C0019169 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1096264 (UMLS CUI [3,1])
C1658604 (UMLS CUI [3,2])
Communicable Diseases Requirement Anti-Infective Agents Intravenous | Communicable Diseases Requirement Anti-Infective Agents Oral
Item
infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003204 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003204 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female subject who is pregnant or breast-feeding or considering becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])