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ID

40156

Beskrivning

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Nyckelord

  1. 2020-03-18 2020-03-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 mars 2020

DOI

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Licens

Creative Commons BY-NC 4.0

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    Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

    Visit 2 - Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score

    Pain Assessment VAS Score
    Beskrivning

    Pain Assessment VAS Score

    Alias
    UMLS CUI-1
    C1161170
    UMLS CUI-2
    C0042815
    Pain Assessment VAS Score - Assessment Date
    Beskrivning

    Pain Assessment VAS Score - Assessment Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1161170
    UMLS CUI [1,2]
    C0042815
    UMLS CUI [2,1]
    C1161170
    UMLS CUI [2,2]
    C0042815
    UMLS CUI [2,3]
    C2985720
    Pain Assessment VAS Score
    Beskrivning

    Pain Assessment VAS Score

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1161170
    UMLS CUI [1,2]
    C0042815
    Pain Assessment VAS Score - ISO Language code
    Beskrivning

    Pain Assessment VAS Score - ISO Language code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1161170
    UMLS CUI [1,2]
    C0042815
    UMLS CUI [2]
    C1708640
    Patient's Global Assessment of Arthritis Condition VAS Score
    Beskrivning

    Patient's Global Assessment of Arthritis Condition VAS Score

    Alias
    UMLS CUI-1
    C0281858
    UMLS CUI-2
    C0003864
    UMLS CUI-3
    C0449438
    UMLS CUI-4
    C0449820
    Arthritis Condition VAS Score - Assessment Date
    Beskrivning

    Arthritis Condition VAS Score - Assessment Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0003864
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0449820
    UMLS CUI [2]
    C2985720
    VAS Score
    Beskrivning

    VAS Score

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2960751
    Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    Beskrivning

    Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0281858
    UMLS CUI [1,2]
    C0003864
    UMLS CUI [1,3]
    C0449438
    UMLS CUI [1,4]
    C0449820
    UMLS CUI [2]
    C1708640
    Physician's Global Assessment of Arthritis Condition VAS Score
    Beskrivning

    Physician's Global Assessment of Arthritis Condition VAS Score

    Alias
    UMLS CUI-1
    C0281858
    UMLS CUI-2
    C0003864
    UMLS CUI-3
    C0449438
    UMLS CUI-4
    C0449820
    UMLS CUI-5
    C0031831
    Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
    Beskrivning

    Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0003864
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0449820
    UMLS CUI [1,4]
    C0031831
    UMLS CUI [2]
    C2985720
    Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
    Beskrivning

    Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0003864
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0449820
    UMLS CUI [1,4]
    C0031831
    Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    Beskrivning

    Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0003864
    UMLS CUI [1,2]
    C0449438
    UMLS CUI [1,3]
    C0449820
    UMLS CUI [1,4]
    C0031831
    UMLS CUI [2]
    C1708640

    Similar models

    Visit 2 - Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Pain Assessment VAS Score
    C1161170 (UMLS CUI-1)
    C0042815 (UMLS CUI-2)
    Pain Assessment VAS Score - Assessment Date
    Item
    Pain Assessment VAS Score - Assessment Date
    date
    C1161170 (UMLS CUI [1,1])
    C0042815 (UMLS CUI [1,2])
    C1161170 (UMLS CUI [2,1])
    C0042815 (UMLS CUI [2,2])
    C2985720 (UMLS CUI [2,3])
    Pain Assessment VAS Score
    Item
    Pain Assessment VAS Score
    integer
    C1161170 (UMLS CUI [1,1])
    C0042815 (UMLS CUI [1,2])
    Item
    Pain Assessment VAS Score - ISO Language code
    text
    C1161170 (UMLS CUI [1,1])
    C0042815 (UMLS CUI [1,2])
    C1708640 (UMLS CUI [2])
    Code List
    Pain Assessment VAS Score - ISO Language code
    CL Item
    Danish  (DAN)
    CL Item
    English  (ENG)
    CL Item
    Finnish  (FIN)
    CL Item
    French  (FRE)
    CL Item
    German  (GER)
    CL Item
    Italian  (ITA)
    CL Item
    Korean  (KOR)
    CL Item
    Norwegian  (NOR)
    CL Item
    Spanish  (SPA)
    CL Item
    Swedish  (SWE)
    CL Item
    Dutch  (DUT)
    CL Item
    Portuguese (POR)
    Item Group
    Patient's Global Assessment of Arthritis Condition VAS Score
    C0281858 (UMLS CUI-1)
    C0003864 (UMLS CUI-2)
    C0449438 (UMLS CUI-3)
    C0449820 (UMLS CUI-4)
    Arthritis Condition VAS Score - Assessment Date
    Item
    Arthritis Condition VAS Score - Assessment Date
    date
    C0003864 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0449820 (UMLS CUI [1,3])
    C2985720 (UMLS CUI [2])
    VAS Score
    Item
    VAS Score
    integer
    C2960751 (UMLS CUI [1])
    Item
    Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    text
    C0281858 (UMLS CUI [1,1])
    C0003864 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    C0449820 (UMLS CUI [1,4])
    C1708640 (UMLS CUI [2])
    Code List
    Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    CL Item
    Danish  (DAN)
    CL Item
    English  (ENG)
    CL Item
    Finnish  (FIN)
    CL Item
    French  (FRE)
    CL Item
    German  (GER)
    CL Item
    Italian  (ITA)
    CL Item
    Korean  (KOR)
    CL Item
    Norwegian  (NOR)
    CL Item
    Spanish  (SPA)
    CL Item
    Swedish  (SWE)
    CL Item
    Dutch; Flemish  (DUT)
    CL Item
    Portuguese  (POR)
    CL Item
    Afrikaans  (AFR)
    CL Item
    Czech  (CES)
    CL Item
    Chinese  (CHI)
    CL Item
    Hungarian  (HUN)
    CL Item
    Lithuanian  (LIT)
    CL Item
    Polish  (POL)
    CL Item
    Romanian  (RUM)
    CL Item
    Russian (RUS)
    Item Group
    Physician's Global Assessment of Arthritis Condition VAS Score
    C0281858 (UMLS CUI-1)
    C0003864 (UMLS CUI-2)
    C0449438 (UMLS CUI-3)
    C0449820 (UMLS CUI-4)
    C0031831 (UMLS CUI-5)
    Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
    Item
    Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
    date
    C0003864 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0449820 (UMLS CUI [1,3])
    C0031831 (UMLS CUI [1,4])
    C2985720 (UMLS CUI [2])
    Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
    Item
    Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
    integer
    C0003864 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0449820 (UMLS CUI [1,3])
    C0031831 (UMLS CUI [1,4])
    Item
    Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    text
    C0003864 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    C0449820 (UMLS CUI [1,3])
    C0031831 (UMLS CUI [1,4])
    C1708640 (UMLS CUI [2])
    Code List
    Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
    CL Item
    Danish  (DAN)
    CL Item
    English  (ENG)
    CL Item
    Finnish  (FIN)
    CL Item
    French  (FRE)
    CL Item
    German  (GER)
    CL Item
    Italian  (ITA)
    CL Item
    Korean  (KOR)
    CL Item
    Norwegian  (NOR)
    CL Item
    Spanish  (SPA)
    CL Item
    Swedish  (SWE)
    CL Item
    Dutch  (DUT)
    CL Item
    Portuguese (POR)

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