diagnosis of rheumatoid arthritis
Item
has a diagnosis of rheumatoid arthritis (ra) for at least 6 months before screening.
boolean
C0003873 (UMLS CUI [1])
anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum
Item
positive test for either anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum at screening.
boolean
C0035448 (UMLS CUI [1])
C1138802 (UMLS CUI [2])
active ra defined as persistent disease activity
Item
has active ra defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum crp ≥ 0.70 mg/dl at screening.
boolean
C3871171 (UMLS CUI [1])
has been treated with and tolerated methotrexate
Item
has been treated with and tolerated methotrexate (mtx) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening
boolean
C0025677 (UMLS CUI [1])
Must be post-menopausal or use an acceptable form of birth control
Item
must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control
boolean
C0232970 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
daily pain diary
Item
has completed at least 5 days of daily pain diary in the 10 days prior to randomization.
boolean
C0451366 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Other inflammatory diseases such as lupus
Item
has inflammatory diseases other than ra, such as lupus.
boolean
C0009488 (UMLS CUI [1,1])
C1290886 (UMLS CUI [1,2])
is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.
Item
is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines.
boolean
C2347852 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
has ever received any biologic agent for a rheumatic indication
Item
has ever received any biologic agent for a rheumatic indication.
boolean
C2347852 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
Concurrent, severe and uncontrolled Comorbidity
Item
has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
boolean
C0009488 (UMLS CUI [1])
renal insufficiency
Item
has moderate or severe renal insufficiency
boolean
C1565489 (UMLS CUI [1])
infection
Item
has a recent (within 2 months) serious infection
boolean
C0009450 (UMLS CUI [1])
opportunistic infection
Item
has had an opportunistic infection.
boolean
C0029118 (UMLS CUI [1])
has had cancer within the past 5 years
Item
has had cancer within the past 5 years (except certain skin or cervical conditions)
boolean
C0006826 (UMLS CUI [1])
Substance use disorder
Item
has abused substances or alcohol within the past 2 years
boolean
C0038586 (UMLS CUI [1])
hepatitis b or c infection
Item
has active hepatitis b or c infection
boolean
C0019196 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
has had active tuberculosis
Item
has had active tuberculosis
boolean
C0151332 (UMLS CUI [1])
has had exposure to tuberculosis without preventative treatment
Item
has had exposure to tuberculosis without preventative treatment
boolean
C0149796 (UMLS CUI [1])
C0199176 (UMLS CUI [2])