Rheumatoid Arthritis
Item
patients have a diagnosis of ra according to the revised 1987 criteria of the american rheumatism association
boolean
C0003873 (UMLS CUI [1])
Methotrexate
Item
have been receiving background mtx for at least 2 months prior to week -4
boolean
C0025677 (UMLS CUI [1])
Etanercept Subcutaneous Dose Stable
Item
have been receiving a stable etanercept dose of 25 mg subcutaneously twice weekly for at least 2 months prior to week -4
boolean
C0717758 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Methotrexate Oral Product Dose Stable | Methotrexate Injectable Product Dose Stable
Item
must have been using oral or parenteral mtx for the 2 months prior to screening and at a stable dose of 7.5 to 25 mg per week between week -4 and week 0
boolean
C3216566 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C3216565 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Rheumatoid Arthritis Signs and Symptoms Improvement | Etanercept Disease Response | Methotrexate Disease Response
Item
have shown improvement in signs and symptoms of ra in response to etanercept and mtx according to both the patient and the treating physician
boolean
C0003873 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C2986411 (UMLS CUI [1,3])
C0717758 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0025677 (UMLS CUI [3,1])
C1704632 (UMLS CUI [3,2])
Rheumatoid Arthritis | Tender joint count | Swollen joint count
Item
have active disease as defined by both a tjc of at least 9 (on the 68 joint set) and sjc of at least 6 (on the 66 joint set)
boolean
C0003873 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
PPD skin test negative | PPD induration
Item
have a documented negative reaction to a purified protein derivative (ppd) skin test (ppd induration< 5 mm) performed within 3 months prior to the week 0 visit
boolean
C1328483 (UMLS CUI [1])
C2059397 (UMLS CUI [2])
Adrenal Cortex Hormones Drug Administration Routes Any | Adrenal Cortex Hormones Dose Prednisone Equivalent | Adrenal Cortex Hormones Dose Unstable
Item
patients have been receiving corticosteroids (ie, via any route) at doses > 10 mg prednisone equivalent daily or have not been taking a stable dose of corticosteroids for at least 1 month prior to week -4
boolean
C0001617 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0205163 (UMLS CUI [2,4])
C0001617 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
Non-Steroidal Anti-Inflammatory Agents Started | Non-Steroidal Anti-Inflammatory Agents Dose Unstable
Item
have started receiving nonsteroidal anti-inflammatory drugs (nsaids) within 1 month of week -4 or have not been on a stable dose of nsaids for at least 1 month prior to week -4
boolean
C0003211 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Antirheumatic Drugs, Disease-Modifying | Immunosuppressive Agents | Methotrexate
Item
have received disease modifying anti-rheumatic drugs (dmards) or immunosuppressives (except mtx) for at least 1 month prior to week 0
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
infliximab | Tumor necrosis factor alpha (TNF-) inhibitors | Etanercept | Pentoxifylline | Thalidomide
Item
patients who have received any prior treatment with infliximab or with any other therapeutic agent targeted at reducing tnf, except etanercept, (e.g.pentoxifylline or thalidomide)
boolean
C0666743 (UMLS CUI [1])
C3653350 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C0030899 (UMLS CUI [4])
C0039736 (UMLS CUI [5])
Congestive heart failure | Patients Asymptomatic Disease Controlled
Item
patients with a concomitant diagnosis of congestive heart failure, including medically controlled asymptomatic patients
boolean
C0018802 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C2911690 (UMLS CUI [2,3])
Malignant Neoplasms
Item
any current known malignancy or history of malignancy within the previous 5 years
boolean
C0006826 (UMLS CUI [1])
Communicable Diseases Serious | Chronic infectious disease | Hepatitis | Pneumonia | Pyelonephritis | Opportunistic Infections
Item
serious infection within the past 3 months or history of chronic infection such as hepatitis, pneumonia, or pyelonephritis in the previous 3 months, any opportunistic infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0151317 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0032285 (UMLS CUI [4])
C0034186 (UMLS CUI [5])
C0029118 (UMLS CUI [6])
Substance Use Disorders
Item
known substance abuse (drug or alcohol) within the previous 3 years
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding | Gender Planned Pregnancy
Item
are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])