Eligibility Rheumatoid Arthritis NCT00654368

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StudyEvent: Eligibility
1. Eligibility Rheumatoid Arthritis NCT00654368

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

18 years of age or older at the baseline visit

boolean

C0001779 (UMLS CUI [1])

Rheumatoid Arthritis | Symptom Onset Duration

Item

an american college of rheumatology(acr) diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months

boolean

C0003873 (UMLS CUI [1])
C4086878 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])

Swollen joint count Disease activity score using 28 joint count

Item

active disease of at least 3 swollen joints from the disease activity severity 28 at the baseline visit

boolean

C0451521 (UMLS CUI [1,1])
C2711347 (UMLS CUI [1,2])

Disease activity score using 28 joint count

Item

a disease activity severity 28 score of ≥ 3.2 at the baseline visit

boolean

C2711347 (UMLS CUI [1])

Etanercept therapy Absent

Item

have not previously received etanercept therapy

boolean

C4075969 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

Etanercept therapy Start Able

Item

able to start etanercept therapy per the approved product monograph

boolean

C4075969 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])

Methotrexate Dose Stable U/week

Item

able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 weeks and this dose has been stable at least 4 weeks before the baseline visit

boolean

C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])

Informed Consent | Informed Consent Patient Representative

Item

the patient or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedures are performed

boolean

C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

PPD skin test positive | Tuberculosis treatment Absent | Chest X-ray Negative Eligible | Tuberculosis treatment Completed Eligible

Item

patients who have a positive purified protein derivative (ppd) skin test and who do not have a documented course of anti-tuberculosis therapy. patients with a positive ppd skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. the full course of anti-tuberculosis therapy must be completed

boolean

C1699735 (UMLS CUI [1])
C0749724 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0039985 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C1548635 (UMLS CUI [3,3])
C0749724 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C1548635 (UMLS CUI [4,3])

infliximab | adalimumab

Item

patients who have previously received infliximab or adalimumab

boolean

C0666743 (UMLS CUI [1])
C1122087 (UMLS CUI [2])

Communicable Diseases

Item

active infections within 2 weeks of the baseline visit or during the study period

boolean

C0009450 (UMLS CUI [1])

Item

any history of human immunodeficiency (hiv) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis b, hepatitis c, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years

boolean

C0019693 (UMLS CUI [1])
C0041296 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0026769 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
C0010828 (UMLS CUI [7])
C0010583 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0007117 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0553723 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0851140 (UMLS CUI [12,2])

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Item

women who are pregnant or lactating or of childbearing potential who are not using adequate contraception

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])

Therapy, Investigational

Item

receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period

boolean

C0949266 (UMLS CUI [1])

Medical condition Uncontrolled Excludes Etanercept

Item

presence of any significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept, as outlined in the product monograph

boolean

C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0717758 (UMLS CUI [1,4])

Patient unavailable Follow-up | Protocol Compliance Unable

Item

participants not available for follow-up assessment or unable to comply with study procedures

boolean

C1301818 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])

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Eligibility Rheumatoid Arthritis NCT00654368