Eligibility Rheumatoid Arthritis NCT00317538

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StudyEvent: Eligibility
1. Eligibility Rheumatoid Arthritis NCT00317538

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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])

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Eligibility Rheumatoid Arthritis NCT00317538