Rheumatoid Arthritis
Item
diagnosis of ra according to the 2010 acr/eular classification criteria .
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dosage Stable U/week
Item
must be on a stable mtx dose (7.5 to 25 mg/week)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Able to read Consent Form | Comprehension Consent Form | Interventional procedure Completion | Able to communicate Research Personnel
Item
subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
boolean
C0586740 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0009797 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C2364293 (UMLS CUI [4,1])
C0035173 (UMLS CUI [4,2])
Protocol Compliance
Item
are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Free of Duration
Item
prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Life threatening illness compromises Patient safety | Medical condition compromises Patient safety | Organ system Dysfunction compromises Patient safety | Life threatening illness Interferes with ACP-196 Absorption | Medical condition Interferes with ACP-196 Absorption | Organ system Dysfunction Interferes with ACP-196 Absorption | Life threatening illness Interferes with ACP-196 Metabolism | Medical condition Interferes with ACP-196 Metabolism | Organ system Dysfunction Interferes with ACP-196 Metabolism | Life threatening illness Research results At risk | Medical condition Research results At risk | Organ system Dysfunction Research results At risk
Item
a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk.
boolean
C3846017 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0460002 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C2945640 (UMLS CUI [3,3])
C1113679 (UMLS CUI [3,4])
C3846017 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C3827171 (UMLS CUI [4,3])
C0237442 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C3827171 (UMLS CUI [5,3])
C0237442 (UMLS CUI [5,4])
C0460002 (UMLS CUI [6,1])
C3887504 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C3827171 (UMLS CUI [6,4])
C0237442 (UMLS CUI [6,5])
C3846017 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C3827171 (UMLS CUI [7,3])
C0025519 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C3827171 (UMLS CUI [8,3])
C0025519 (UMLS CUI [8,4])
C0460002 (UMLS CUI [9,1])
C3887504 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C3827171 (UMLS CUI [9,4])
C0025519 (UMLS CUI [9,5])
C3846017 (UMLS CUI [10,1])
C0683954 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C3843040 (UMLS CUI [11,1])
C0683954 (UMLS CUI [11,2])
C1444641 (UMLS CUI [11,3])
C0460002 (UMLS CUI [12,1])
C3887504 (UMLS CUI [12,2])
C0683954 (UMLS CUI [12,3])
C1444641 (UMLS CUI [12,4])
Investigational New Drugs
Item
subjects who have taken any investigational drug within the previous 30 days before randomization.
boolean
C0013230 (UMLS CUI [1])
DMARDs synthetic | leflunomide | Azathioprine | Cyclosporine | Penicillamine | Gold salt
Item
use of all other synthetic disease-modifying antirheumatic drugs (dmards) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
boolean
C0242708 (UMLS CUI [1,1])
C1883254 (UMLS CUI [1,2])
C0063041 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0030817 (UMLS CUI [5])
C0302210 (UMLS CUI [6])
Etanercept | anakinra | tofacitinib
Item
use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
boolean
C0717758 (UMLS CUI [1])
C0245109 (UMLS CUI [2])
C2930696 (UMLS CUI [3])
abatacept | Humira | infliximab | tocilizumab
Item
use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
boolean
C1619966 (UMLS CUI [1])
C1171255 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C1609165 (UMLS CUI [4])