Rheumatoid Arthritis
Item
subject must have a diagnosis of rheumatoid arthritis based on the american college of rheumatology association
boolean
C0003873 (UMLS CUI [1])
Active disease
Item
the subject has active disease at both screening and baseline, as defined:
boolean
C2707252 (UMLS CUI [1])
Tender joint count | Joint Painful Count
Item
≥4 joints tender or painful on motion, and
boolean
C0451530 (UMLS CUI [1])
C0022417 (UMLS CUI [2,1])
C0030193 (UMLS CUI [2,2])
C0750480 (UMLS CUI [2,3])
Swollen joint count
Item
≥4 joints swollen;
boolean
C0451521 (UMLS CUI [1])
Synovitis Knee joint Quantity | Synovitis Elbow joint Quantity | Synovitis Wrist joint Quantity | Synovitis Metacarpophalangeal joint Quantity | Joints Appropriate Biopsy Specified
Item
the subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique
boolean
C0039103 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0039103 (UMLS CUI [2,1])
C0013770 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0039103 (UMLS CUI [3,1])
C1279139 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0039103 (UMLS CUI [4,1])
C0025525 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0022417 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0005558 (UMLS CUI [5,3])
C0205369 (UMLS CUI [5,4])
Arthroscopy Joint Involved
Item
no arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
boolean
C0003904 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Intraarticular steroid injection Joint Involved
Item
no intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
boolean
C2064783 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Hematological Disease | Hemoglobin measurement | Hematocrit procedure | Synovial biopsy
Item
subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels < 9.0 gm/dl or hematocrit < 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0018939 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0018935 (UMLS CUI [3])
C0150887 (UMLS CUI [4])
White Blood Cell Count procedure | Absolute neutrophil count | Synovial biopsy
Item
an absolute white blood cell (wbc) count of < 3.0 x 109/l (<3000/mm3) or absolute neutrophil count of <1.2 x 109/l (<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0150887 (UMLS CUI [3])
Thrombocytopenia | Platelet Count measurement | Synovial biopsy
Item
thrombocytopenia, as defined by a platelet count <100 x 109/l (< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0150887 (UMLS CUI [3])
Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
estimated gfr less than 40 ml/min based on cockcroft gault calculation .
boolean
C3811844 (UMLS CUI [1,1])
C2924627 (UMLS CUI [1,2])