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40419

Beschreibung

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT01636843

Link

https://clinicaltrials.gov/show/NCT01636843

Stichworte

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  1. 19.04.20 19.04.20 -
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See clinicaltrials.gov

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19. April 2020

DOI

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    Eligibility Inflammation NCT01636843

    Englisch

    Eligibility Inflammation NCT01636843

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    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
    Beschreibung

    Informed Consent

    Datentyp

    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
    Beschreibung

    Rheumatoid Arthritis Duration

    Datentyp

    boolean

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

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2711398
    UMLS CUI [2]
    C2711873
    UMLS CUI [3]
    C0201657
    patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
    Beschreibung

    Methotrexate | Hydroxychloroquine | Chloroquine | Hydroxychloroquine Absent | Chloroquine Absent | Methotrexate Dose | Relationship Intolerance to Methotrexate | Hydroxychloroquine Oral Dose | Chloroquine Oral Dose

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0025677
    UMLS CUI [2]
    C0020336
    UMLS CUI [3]
    C0008269
    UMLS CUI [4,1]
    C0020336
    UMLS CUI [4,2]
    C0332197
    UMLS CUI [5,1]
    C0008269
    UMLS CUI [5,2]
    C0332197
    UMLS CUI [6,1]
    C0025677
    UMLS CUI [6,2]
    C0178602
    UMLS CUI [7,1]
    C0439849
    UMLS CUI [7,2]
    C1744706
    UMLS CUI [7,3]
    C0025677
    UMLS CUI [8,1]
    C0020336
    UMLS CUI [8,2]
    C1527415
    UMLS CUI [8,3]
    C0178602
    UMLS CUI [9,1]
    C0008269
    UMLS CUI [9,2]
    C1527415
    UMLS CUI [9,3]
    C0178602
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

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

    Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis

    Datentyp

    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)
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Pregnancy | Breast Feeding | Pregnancy, Planned

    Datentyp

    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
    Beschreibung

    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

    Datentyp

    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
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Inflammation NCT01636843

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. c-reactive protein (crp) above or equal to 1.0 mg/dl (10 mg/l)
    boolean
    C2711398 (UMLS CUI [1])
    C2711873 (UMLS CUI [2])
    C0201657 (UMLS CUI [3])
    Methotrexate | Hydroxychloroquine | Chloroquine | Hydroxychloroquine Absent | Chloroquine Absent | Methotrexate Dose | Relationship Intolerance to Methotrexate | Hydroxychloroquine Oral Dose | Chloroquine Oral Dose
    Item
    patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
    boolean
    C0025677 (UMLS CUI [1])
    C0020336 (UMLS CUI [2])
    C0008269 (UMLS CUI [3])
    C0020336 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    C0008269 (UMLS CUI [5,1])
    C0332197 (UMLS CUI [5,2])
    C0025677 (UMLS CUI [6,1])
    C0178602 (UMLS CUI [6,2])
    C0439849 (UMLS CUI [7,1])
    C1744706 (UMLS CUI [7,2])
    C0025677 (UMLS CUI [7,3])
    C0020336 (UMLS CUI [8,1])
    C1527415 (UMLS CUI [8,2])
    C0178602 (UMLS CUI [8,3])
    C0008269 (UMLS CUI [9,1])
    C1527415 (UMLS CUI [9,2])
    C0178602 (UMLS CUI [9,3])
    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])
    Zum Seitenanfang zurückkehren 

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