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ID

15960

Beschrijving

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission; ODM derived from: https://clinicaltrials.gov/show/NCT02373813

Link

https://clinicaltrials.gov/show/NCT02373813

Trefwoorden

  1. 21-06-16 21-06-16 -
Geüploaded op

21 juni 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Rheumatoid Arthritis NCT02373813

    Eligibility Rheumatoid Arthritis NCT02373813

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    subjects must be adults with a history of moderate to severe rheumatoid arthritis;
    Beschrijving

    Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2,1]
    C0003873
    UMLS CUI [2,2]
    C0205081
    UMLS CUI [3,1]
    C0003873
    UMLS CUI [3,2]
    C0205082
    subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a simplified disease activity index ≤ 3.3 at screening and at the end of the run-in period.
    Beschrijving

    Rheumatoid Arthritis | Disease control Very good | Simplified disease activity index

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0003873
    UMLS CUI [2,1]
    C0920467
    UMLS CUI [2,2]
    C3641222
    UMLS CUI [3]
    C3869582
    subjects must be on etanercept plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. the methotrexate dose must be 10 to 25 mg per week for ≥
    Beschrijving

    Therapeutic procedure Etanercept Methotrexate

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0717758
    UMLS CUI [1,3]
    C0025677
    6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period.
    Beschrijving

    Methotrexate Dosage Stable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0205360
    subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.
    Beschrijving

    Active tuberculosis Absent | Tuberculosis test negative

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0151332
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2]
    C2242735
    exclusion criteria:- subject has used biologic disease modifying antirheumatic drug other than etanercept or has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1
    Beschrijving

    Exclusion Criteria | Antirheumatic Drugs, Disease-Modifying | Etanercept | Janus kinase inhibitor Oral

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    UMLS CUI [2]
    C0242708
    UMLS CUI [3]
    C0717758
    UMLS CUI [4,1]
    C3854325
    UMLS CUI [4,2]
    C1527415
    subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1.
    Beschrijving

    Communicable Diseases | Chronic infectious disease | Focal Infection | Indication Anti-Infective Agents

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0151317
    UMLS CUI [3]
    C0016397
    UMLS CUI [4,1]
    C3146298
    UMLS CUI [4,2]
    C0003204
    subject has known alcohol addiction or dependency or uses alcohol daily.
    Beschrijving

    Alcohol dependence

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001973
    subject has one or more significant concurrent medical conditions per investigator judgment, including the following:
    Beschrijving

    Comorbidity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    poorly controlled diabetes
    Beschrijving

    Diabetes mellitus poor control

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0860161
    chronic kidney disease stage iiib, iv, or v
    Beschrijving

    Chronic Kidney Diseases | chronic kidney disease stage

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1561643
    UMLS CUI [2]
    C2074731
    symptomatic heart failure (new york heart association class ii, iii, or iv)
    Beschrijving

    Heart failure Symptomatic | New York Heart Association Classification

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0018801
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C1275491
    myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
    Beschrijving

    Myocardial Infarction | Angina, Unstable

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    UMLS CUI [2]
    C0002965
    uncontrolled hypertension
    Beschrijving

    Uncontrolled hypertension

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    severe chronic pulmonary disease (eg, requiring oxygen therapy)
    Beschrijving

    Severe chronic obstructive pulmonary disease | Oxygen Therapy Required

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0730607
    UMLS CUI [2,1]
    C0184633
    UMLS CUI [2,2]
    C1514873
    multiple sclerosis or any other demyelinating disease
    Beschrijving

    Multiple Sclerosis | Demyelinating Disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0026769
    UMLS CUI [2]
    C0011303
    major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary sjögren's syndrome)
    Beschrijving

    Chronic inflammatory disorder Major | Connective Tissue Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Sjogren's Syndrome Secondary

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1290886
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [2]
    C0009782
    UMLS CUI [3]
    C0003873
    UMLS CUI [4]
    C0024141
    UMLS CUI [5,1]
    C1527336
    UMLS CUI [5,2]
    C0175668

    Similar models

    Eligibility Rheumatoid Arthritis NCT02373813

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe
    Item
    subjects must be adults with a history of moderate to severe rheumatoid arthritis;
    boolean
    C0001675 (UMLS CUI [1])
    C0003873 (UMLS CUI [2,1])
    C0205081 (UMLS CUI [2,2])
    C0003873 (UMLS CUI [3,1])
    C0205082 (UMLS CUI [3,2])
    Rheumatoid Arthritis | Disease control Very good | Simplified disease activity index
    Item
    subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a simplified disease activity index ≤ 3.3 at screening and at the end of the run-in period.
    boolean
    C0003873 (UMLS CUI [1])
    C0920467 (UMLS CUI [2,1])
    C3641222 (UMLS CUI [2,2])
    C3869582 (UMLS CUI [3])
    Therapeutic procedure Etanercept Methotrexate
    Item
    subjects must be on etanercept plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. the methotrexate dose must be 10 to 25 mg per week for ≥
    boolean
    C0087111 (UMLS CUI [1,1])
    C0717758 (UMLS CUI [1,2])
    C0025677 (UMLS CUI [1,3])
    Methotrexate Dosage Stable
    Item
    6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period.
    boolean
    C0025677 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0205360 (UMLS CUI [1,3])
    Active tuberculosis Absent | Tuberculosis test negative
    Item
    subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.
    boolean
    C0151332 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C2242735 (UMLS CUI [2])
    Exclusion Criteria | Antirheumatic Drugs, Disease-Modifying | Etanercept | Janus kinase inhibitor Oral
    Item
    exclusion criteria:- subject has used biologic disease modifying antirheumatic drug other than etanercept or has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1
    boolean
    C0680251 (UMLS CUI [1])
    C0242708 (UMLS CUI [2])
    C0717758 (UMLS CUI [3])
    C3854325 (UMLS CUI [4,1])
    C1527415 (UMLS CUI [4,2])
    Communicable Diseases | Chronic infectious disease | Focal Infection | Indication Anti-Infective Agents
    Item
    subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1.
    boolean
    C0009450 (UMLS CUI [1])
    C0151317 (UMLS CUI [2])
    C0016397 (UMLS CUI [3])
    C3146298 (UMLS CUI [4,1])
    C0003204 (UMLS CUI [4,2])
    Alcohol dependence
    Item
    subject has known alcohol addiction or dependency or uses alcohol daily.
    boolean
    C0001973 (UMLS CUI [1])
    Comorbidity
    Item
    subject has one or more significant concurrent medical conditions per investigator judgment, including the following:
    boolean
    C0009488 (UMLS CUI [1])
    Diabetes mellitus poor control
    Item
    poorly controlled diabetes
    boolean
    C0860161 (UMLS CUI [1])
    Chronic Kidney Diseases | chronic kidney disease stage
    Item
    chronic kidney disease stage iiib, iv, or v
    boolean
    C1561643 (UMLS CUI [1])
    C2074731 (UMLS CUI [2])
    Heart failure Symptomatic | New York Heart Association Classification
    Item
    symptomatic heart failure (new york heart association class ii, iii, or iv)
    boolean
    C0018801 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C1275491 (UMLS CUI [2])
    Myocardial Infarction | Angina, Unstable
    Item
    myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
    boolean
    C0027051 (UMLS CUI [1])
    C0002965 (UMLS CUI [2])
    Uncontrolled hypertension
    Item
    uncontrolled hypertension
    boolean
    C1868885 (UMLS CUI [1])
    Severe chronic obstructive pulmonary disease | Oxygen Therapy Required
    Item
    severe chronic pulmonary disease (eg, requiring oxygen therapy)
    boolean
    C0730607 (UMLS CUI [1])
    C0184633 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    Multiple Sclerosis | Demyelinating Disease
    Item
    multiple sclerosis or any other demyelinating disease
    boolean
    C0026769 (UMLS CUI [1])
    C0011303 (UMLS CUI [2])
    Chronic inflammatory disorder Major | Connective Tissue Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Sjogren's Syndrome Secondary
    Item
    major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary sjögren's syndrome)
    boolean
    C1290886 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0009782 (UMLS CUI [2])
    C0003873 (UMLS CUI [3])
    C0024141 (UMLS CUI [4])
    C1527336 (UMLS CUI [5,1])
    C0175668 (UMLS CUI [5,2])

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