rheumatoid arthritis
Item
have a diagnosis of rheumatoid arthritis (ra) for at least 3 months before screening
boolean
C0003873 (UMLS CUI [1])
rheumatoid arthritis tender joints Joint swelling
Item
have moderately to severely active ra with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
boolean
C0003873 (UMLS CUI [1,1])
C0240094 (UMLS CUI [1,2])
C0152031 (UMLS CUI [1,3])
disease-modifying antirheumatic drugs; methotrexate; sulfasalazine
Item
have been unresponsive to single-agent or combination disease-modifying antirheumatic drugs (dmard) therapy that includes methotrexate (mtx) or sulfasalazine (ssz) due to lack of benefit after at least 12 weeks of dmard, as assessed by the treating physician
boolean
C0242708 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0036078 (UMLS CUI [3])
oral corticosteroids
Item
if using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. if currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent
boolean
C3653473 (UMLS CUI [1])
nonsteroidal anti-inflammatory drug
Item
if using non nonsteroidal anti-inflammatory drug (nsaids) or other analgesics for ra, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
boolean
C0003211 (UMLS CUI [1])
Antirheumatic Drugs, Disease-Modifying Non-biological
Item
if using non-biologic dmard such as mtx, ssz, hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the dmard
boolean
C0242708 (UMLS CUI [1,1])
C0445097 (UMLS CUI [1,2])
hypersensitivity Anti-tumor necrosis factor alpha drug
Item
has a history of intolerance to at least 2 or inadequate response to at least 1 anti-tumor necrosis factor alpha agent after 3 months of therapy
boolean
C0020517 (UMLS CUI [1,1])
C1562242 (UMLS CUI [1,2])
TNF-Blocker infliximab
Item
has received infliximab, golimumab, adalimumab, or certolizumab pegol within 3 months of the first study agent administration
boolean
C2266940 (UMLS CUI [1,1])
C0666743 (UMLS CUI [1,2])
etanercept
Item
has received etanercept or yisaipu within 6 weeks of the first study agent administration
boolean
C0717758 (UMLS CUI [1])
hypersensitivity tocilizumab
Item
has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-il-6 receptor) therapy
boolean
C0020517 (UMLS CUI [1,1])
C1609165 (UMLS CUI [1,2])
rituximab
Item
has used b-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low b cell level caused by previous b-cell depletion therapy
boolean
C0393022 (UMLS CUI [1])
anakinra
Item
has used anakinra within 4 weeks of first study agent administration
boolean
C0245109 (UMLS CUI [1])
biologic therapy rheumatoid arthritis
Item
has used any other biologic therapy for the treatment of ra within 3 months of the first study agent administration
boolean
C0005527 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
corticosteroids injection intra-articular intramuscular Intravenous
Item
has received intra-articular (ia), intramuscular (im), or intravenous (iv) corticosteroids for ra, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration-
boolean
C2095490 (UMLS CUI [1,1])
C0442108 (UMLS CUI [1,2])
C0442117 (UMLS CUI [1,3])
C0348016 (UMLS CUI [1,4])
leflunomide; screening
Item
has received leflunomide within 24 months before the first study agent administration and have not undergone a drug elimination procedure, unless the m1 metabolite is measured and is undetectable. if a drug elimination procedure is performed during screening, the m1 metabolite should be measured and found to be undetectable
boolean
C0063041 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
cytotoxic agent
Item
has a history of cyclophosphamide or cytotoxic agent use
boolean
C0304497 (UMLS CUI [1])
cyclosporine; azathioprine
Item
has received cyclosporine a, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or d-penicillamine within 4 weeks of the first study agent administration
boolean
C0010592 (UMLS CUI [1])
C0004482 (UMLS CUI [2])
investigational drug status
Item
has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half lives, whichever is longer, before the first study agent administration
boolean
C0013230 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])