Rheumatoid Arthritis disease length
Item
fulfillment of the 1987 american college of rheumatology (acr) criteria for ra with a disease duration > 6 months
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid arthritis of wrist Quantity | Joint tenderness | Joint swelling
Item
presence of active disease (defined as both tender and swollen joints) in at least one wrist
boolean
C0409643 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2])
C0152031 (UMLS CUI [3])
Methotrexate | Response Suboptimal | active joint count | Swollen joint count | Tender joint count | Involvement with Wrist | Involvement with Fingers | Involvement with Region Quantity outside Hand
Item
sub-optimal response to methotrexate (mtx) defined by the presence of the following criteria (based on 68/66 joint count): 8 or more swollen joints and 8 or more tender joints (with involvement of the wrist, fingers and at least one region outside the hands) at screening
boolean
C0025677 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C2984009 (UMLS CUI [2,2])
C4067216 (UMLS CUI [3])
C0451521 (UMLS CUI [4])
C0451530 (UMLS CUI [5])
C1314939 (UMLS CUI [6,1])
C0043262 (UMLS CUI [6,2])
C1314939 (UMLS CUI [7,1])
C0016129 (UMLS CUI [7,2])
C1314939 (UMLS CUI [8,1])
C0205147 (UMLS CUI [8,2])
C1265611 (UMLS CUI [8,3])
C0205101 (UMLS CUI [8,4])
C0018563 (UMLS CUI [8,5])
Methotrexate Dose Stable U/week
Item
must be receiving mtx at a stable dose > 15 mg/week at least 12 weeks prior to baseline
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Dose Lowering Acceptable | Toxic effect Documentation Requirement
Item
a lower dose is acceptable if otherwise not tolerated (toxicity documentation required).
boolean
C0178602 (UMLS CUI [1,1])
C2003888 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0175636 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
Antirheumatic Drugs, Disease-Modifying | Methotrexate | Hydroxychloroquine | Sulfasalazine | Tumor Necrosis Factor antagonists | Etanercept | infliximab | adalimumab | abatacept | rituximab | leflunomide | Cyclosporine | Oral gold | Intramuscular gold
Item
patients who are currently receiving disease modifying anti-rheumatic drug (dmard) therapy (other than mtx, hydroxychloroquine or sulfasalazine) including tumor necrosis factor (tnf) antagonists (etanercept, infliximab, and adalimumab), abatacept, rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection) within 8 weeks or 5.5 half-lives, whichever is longer, of screening
boolean
C0242708 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
C0020336 (UMLS CUI [3])
C0036078 (UMLS CUI [4])
C0041368 (UMLS CUI [5,1])
C0243076 (UMLS CUI [5,2])
C0717758 (UMLS CUI [6])
C0666743 (UMLS CUI [7])
C1122087 (UMLS CUI [8])
C1619966 (UMLS CUI [9])
C0393022 (UMLS CUI [10])
C0063041 (UMLS CUI [11])
C0010592 (UMLS CUI [12])
C2585247 (UMLS CUI [13])
C0413372 (UMLS CUI [14])
Comorbidity | Requirement Pharmaceutical Preparations Changing Blood flow | Nitrates | Calcium Channel Blockers | Ergot preparation | Antihypertensive Agents | Pharmaceutical Preparations Migraine
Item
co-existing condition requiring medications that alter vascular flow (e.g., nitrates, calcium channel blockers, ergot containing drugs) [potential effects of antihypertensive and migraine medications will be discussed with the sponsor]
boolean
C0009488 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0232338 (UMLS CUI [2,4])
C0028125 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0304712 (UMLS CUI [5])
C0003364 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C0149931 (UMLS CUI [7,2])
Autoimmune Diseases Comorbidity | Lupus Erythematosus, Systemic
Item
comorbid autoimmune disorders including systemic lupus erythematosus
boolean
C0004364 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
Magnetic Resonance Imaging Receive Unable | Artificial cardiac pacemaker | Defibrillator | Implants | Insertion of interbody fusion cage | Aneurysm clip | Pedicle Screws
Item
unable to undergo an mri examination (e.g., presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip or pedicle screws
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
C0180307 (UMLS CUI [3])
C0021102 (UMLS CUI [4])
C1135559 (UMLS CUI [5])
C0179977 (UMLS CUI [6])
C1961768 (UMLS CUI [7])
Contrast media allergy
Item
allergic to contrast agent
boolean
C0570562 (UMLS CUI [1])
Tattooing of skin Metallic Area MRI
Item
tattoos [in area of examination if contains metallic pigment])
boolean
C0191391 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C0205146 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
Sedation Requirement Probably
Item
or will likely require sedation for the procedure
boolean
C0344106 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0750492 (UMLS CUI [1,3])