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ID

17189

Beschreibung

An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00264550

Link

https://clinicaltrials.gov/show/NCT00264550

Stichworte

Versionen (1)
  1. 30.08.16 30.08.16 -
Hochgeladen am

30. August 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Rheumatoid Arthritis NCT00264550

    Englisch

    Eligibility Rheumatoid Arthritis NCT00264550

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the acr) for at least 3 months prior to screening
    Beschreibung

    Rheumatoid arthritis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003873
    must have been treated with and tolerated methotrexate (mtx) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a mtx dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
    Beschreibung

    methotrexate dosage

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0178602
    have active ra as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)c-reactive protein (crp) >=1.5 mg/dl at screening or erythrocyte sedimentation rate (esr) by westergren method of >= 28 mm in the first hour at screening or baseline, b)morning stiffness of >= 30 minutes at screening and baseline, c)bone erosion by x-ray and/or magnetic resonance imaging (mri) prior to first administration of study agent, d)anti-cyclic citrullinated peptide (anti-ccp) antibody-positive or rheumatoid factor (rf) positive at screening
    Beschreibung

    swollen joint count, tender joint count; CRP, Westergren sedimentation rate; morning stiffness; bone erosion; anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0451521
    UMLS CUI [2]
    C0451530
    UMLS CUI [3]
    C0201657
    UMLS CUI [4]
    C0200705
    UMLS CUI [5]
    C0457086
    UMLS CUI [6]
    C0587240
    UMLS CUI [7]
    C2210597
    UMLS CUI [8]
    C0201660
    if using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
    Beschreibung

    if using oral corticosteroids, must be on a stable dose

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0038317
    UMLS CUI [1,2]
    C0205360
    are considered eligible according to specified tuberculosis (tb) screening criteria
    Beschreibung

    Study Subject Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    have inflammatory diseases other than ra that might confound the evaluation of the benefit of golimumab therapy
    Beschreibung

    other inflammatory diseases that might confound the evaluation of the benefit of golimumab therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1290884
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C2353893
    have had treatment with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than mtx, during the 4 weeks prior to the first administration of study agent
    Beschreibung

    disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0242708
    UMLS CUI [2]
    C0021081
    have had prior treatment with biologic anti-tumor necrosis factor (tnf) drugs (infliximab, etanercept, adalimumab)
    Beschreibung

    treatment with biologic anti-tumor necrosis factor (tnf) drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0281481
    have had history of, or ongoing, chronic or recurrent infectious disease.
    Beschreibung

    chronic or recurrent infectious disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0151317
    UMLS CUI [2]
    C0239998
    have serious infection within 2 months prior to first administration of study agent
    Beschreibung

    Infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    have a history of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to screening
    Beschreibung

    granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1610637
    UMLS CUI [2]
    C0041296
    UMLS CUI [3]
    C0019655
    UMLS CUI [4]
    C0009186
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Rheumatoid Arthritis NCT00264550

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Rheumatoid arthritis
    Item
    have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the acr) for at least 3 months prior to screening
    boolean
    C0003873 (UMLS CUI [1])
    methotrexate dosage
    Item
    must have been treated with and tolerated methotrexate (mtx) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a mtx dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening
    boolean
    C0025677 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    swollen joint count, tender joint count; CRP, Westergren sedimentation rate; morning stiffness; bone erosion; anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive
    Item
    have active ra as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)c-reactive protein (crp) >=1.5 mg/dl at screening or erythrocyte sedimentation rate (esr) by westergren method of >= 28 mm in the first hour at screening or baseline, b)morning stiffness of >= 30 minutes at screening and baseline, c)bone erosion by x-ray and/or magnetic resonance imaging (mri) prior to first administration of study agent, d)anti-cyclic citrullinated peptide (anti-ccp) antibody-positive or rheumatoid factor (rf) positive at screening
    boolean
    C0451521 (UMLS CUI [1])
    C0451530 (UMLS CUI [2])
    C0201657 (UMLS CUI [3])
    C0200705 (UMLS CUI [4])
    C0457086 (UMLS CUI [5])
    C0587240 (UMLS CUI [6])
    C2210597 (UMLS CUI [7])
    C0201660 (UMLS CUI [8])
    if using oral corticosteroids, must be on a stable dose
    Item
    if using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent
    boolean
    C0038317 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    Study Subject Participation Status
    Item
    are considered eligible according to specified tuberculosis (tb) screening criteria
    boolean
    C2348568 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    other inflammatory diseases that might confound the evaluation of the benefit of golimumab therapy
    Item
    have inflammatory diseases other than ra that might confound the evaluation of the benefit of golimumab therapy
    boolean
    C1290884 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C2353893 (UMLS CUI [1,3])
    disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives
    Item
    have had treatment with disease-modifying anti-rheumatic drugs (dmards)/systemic immunosuppressives other than mtx, during the 4 weeks prior to the first administration of study agent
    boolean
    C0242708 (UMLS CUI [1])
    C0021081 (UMLS CUI [2])
    treatment with biologic anti-tumor necrosis factor (tnf) drugs
    Item
    have had prior treatment with biologic anti-tumor necrosis factor (tnf) drugs (infliximab, etanercept, adalimumab)
    boolean
    C0281481 (UMLS CUI [1])
    chronic or recurrent infectious disease
    Item
    have had history of, or ongoing, chronic or recurrent infectious disease.
    boolean
    C0151317 (UMLS CUI [1])
    C0239998 (UMLS CUI [2])
    Infection
    Item
    have serious infection within 2 months prior to first administration of study agent
    boolean
    C0009450 (UMLS CUI [1])
    granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis
    Item
    have a history of latent or active granulomatous infection, including tb, histoplasmosis, or coccidioidomycosis, prior to screening
    boolean
    C1610637 (UMLS CUI [1])
    C0041296 (UMLS CUI [2])
    C0019655 (UMLS CUI [3])
    C0009186 (UMLS CUI [4])
    Zum Seitenanfang zurückkehren 

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