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ID

40418

Description

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics; ODM derived from: https://clinicaltrials.gov/show/NCT01636817

Link

https://clinicaltrials.gov/show/NCT01636817

Keywords

Versions (1)
  1. 4/19/20 4/19/20 -
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See clinicaltrials.gov

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April 19, 2020

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Creative Commons BY 4.0
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    Eligibility Inflammation NCT01636817

    English

    Eligibility Inflammation NCT01636817

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
    Description

    Rheumatoid Arthritis Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003873
    UMLS CUI [1,2]
    C0449238
    active ra, characterised by: a. above 5 tender and above 5 swollen joints based on a 28 joint count b. crp (c-reactive protein) above or equal to 1.0 mg/dl (10 mg/l)
    Description

    Tender 28 joint count | Swollen 28 joint count | C-reactive protein measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711398
    UMLS CUI [2]
    C2711873
    UMLS CUI [3]
    C0201657
    patients must be anti-tnf (anti-tumour necrosis factor) inadequate responders to at least one but not more than two anti-tnf biologics with active disease documented in medical records at the time of discontinuation
    Description

    Non-responder Anti-tumor necrosis factor therapy | Active disease diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0919875
    UMLS CUI [1,2]
    C0281481
    UMLS CUI [2]
    C2707252
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with arthritis due to other autoimmune diseases than ra
    Description

    Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003864
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C0004364
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0003873
    any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
    Description

    Bacterial Infections | Exception resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004623
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1514893
    UMLS CUI [3]
    C0239998
    UMLS CUI [4,1]
    C0348080
    UMLS CUI [4,2]
    C0231203
    UMLS CUI [4,3]
    C0151317
    UMLS CUI [5]
    C0006267
    UMLS CUI [6]
    C0008707
    history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
    Description

    Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4285789
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [2,1]
    C0553576
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1514893
    patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
    Description

    Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007117
    UMLS CUI [2,3]
    C1880198
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0553723
    UMLS CUI [3,3]
    C1880198
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0851140
    UMLS CUI [4,3]
    C1880198
    females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
    Description

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0032992
    any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
    Description

    Disease At risk Patient safety | Laboratory test result abnormal At risk Patient safety | Disease Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Disease At risk Completion of clinical trial | Laboratory test result abnormal At risk Completion of clinical trial

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C1113679
    UMLS CUI [2,1]
    C0438215
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C1113679
    UMLS CUI [3,1]
    C0012634
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C2348568
    UMLS CUI [4,1]
    C0438215
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C2348568
    UMLS CUI [5,1]
    C0012634
    UMLS CUI [5,2]
    C1444641
    UMLS CUI [5,3]
    C2732579
    UMLS CUI [6,1]
    C0438215
    UMLS CUI [6,2]
    C1444641
    UMLS CUI [6,3]
    C2732579
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    Similar models

    Eligibility Inflammation NCT01636817

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
    boolean
    C0021430 (UMLS CUI [1])
    Rheumatoid Arthritis Duration
    Item
    a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
    boolean
    C0003873 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Tender 28 joint count | Swollen 28 joint count | C-reactive protein measurement
    Item
    active ra, characterised by: a. above 5 tender and above 5 swollen joints based on a 28 joint count b. crp (c-reactive protein) above or equal to 1.0 mg/dl (10 mg/l)
    boolean
    C2711398 (UMLS CUI [1])
    C2711873 (UMLS CUI [2])
    C0201657 (UMLS CUI [3])
    Non-responder Anti-tumor necrosis factor therapy | Active disease diagnosis
    Item
    patients must be anti-tnf (anti-tumour necrosis factor) inadequate responders to at least one but not more than two anti-tnf biologics with active disease documented in medical records at the time of discontinuation
    boolean
    C0919875 (UMLS CUI [1,1])
    C0281481 (UMLS CUI [1,2])
    C2707252 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis
    Item
    patients with arthritis due to other autoimmune diseases than ra
    boolean
    C0003864 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C0004364 (UMLS CUI [1,3])
    C1705847 (UMLS CUI [2,1])
    C0003873 (UMLS CUI [2,2])
    Bacterial Infections | Exception resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
    Item
    any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
    boolean
    C0004623 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1514893 (UMLS CUI [2,2])
    C0239998 (UMLS CUI [3])
    C0348080 (UMLS CUI [4,1])
    C0231203 (UMLS CUI [4,2])
    C0151317 (UMLS CUI [4,3])
    C0006267 (UMLS CUI [5])
    C0008707 (UMLS CUI [6])
    Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved
    Item
    history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
    boolean
    C4285789 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0553576 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C1514893 (UMLS CUI [3,2])
    Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured
    Item
    patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007117 (UMLS CUI [2,2])
    C1880198 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0553723 (UMLS CUI [3,2])
    C1880198 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0851140 (UMLS CUI [4,2])
    C1880198 (UMLS CUI [4,3])
    Pregnancy | Breast Feeding | Pregnancy, Planned
    Item
    females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032992 (UMLS CUI [3])
    Disease At risk Patient safety | Laboratory test result abnormal At risk Patient safety | Disease Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Disease At risk Completion of clinical trial | Laboratory test result abnormal At risk Completion of clinical trial
    Item
    any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
    boolean
    C0012634 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C1113679 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C1113679 (UMLS CUI [2,3])
    C0012634 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C2348568 (UMLS CUI [3,3])
    C0438215 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C2348568 (UMLS CUI [4,3])
    C0012634 (UMLS CUI [5,1])
    C1444641 (UMLS CUI [5,2])
    C2732579 (UMLS CUI [5,3])
    C0438215 (UMLS CUI [6,1])
    C1444641 (UMLS CUI [6,2])
    C2732579 (UMLS CUI [6,3])
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