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40157

Description

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

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Versions (1)
  1. 3/18/20 3/18/20 -
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GlaxoSmithKline

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March 18, 2020

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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

    English

    Visit 2 - Run-In Failure; Randomisation Number; Electronically Transferred Lab Data; Liver Assessment

    1 forms  
    Run-In Failure
    Description

    Run-In Failure

    Alias
    UMLS CUI-1
    C1710476 (Trial Screen Failure)
    Was this subject a run-in failure?
    Description

    If yes, complete run-in failure date and reason

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1710476 (Trial Screen Failure)
    Run-in failure date
    Description

    Run-in failure date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Run-in failure primary reason
    Description

    Run-in failure primary reason

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1710476 (Trial Screen Failure)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Randomisation Number
    Description

    Randomisation Number

    Alias
    UMLS CUI-1
    C0034656 (Randomization)
    UMLS CUI-2
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Was the subject able to be randomised?
    Description

    Was the subject able to be randomised?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034656 (Randomization)
    Randomisation number
    Description

    Randomisation number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Date of randomisation
    Description

    Date of randomisation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034656 (Randomization)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Electronically Transferred Lab Data
    Description

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0745590 (lab data)
    UMLS CUI-2
    C1705822 (Transfer Technique)
    LOINC
    LP97172-8
    Haematology Date sample taken
    Description

    Haematology Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [1,2]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Haematology sample taken - Not Done
    Description

    Haematology sample taken - Not Done

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [1,3]
    C1272696 (Not Done)
    SNOMED
    385660001
    Biochemistry Date sample taken
    Description

    Biochemistry Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005477 (Biochemistry)
    UMLS CUI [1,2]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Biochemistry sample taken - Not Done
    Description

    Biochemistry sample taken - Not Done

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0005477 (Biochemistry)
    UMLS CUI [1,3]
    C1272696 (Not Done)
    SNOMED
    385660001
    Urinalysis Date sample taken
    Description

    Urinalysis Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    UMLS CUI [1,2]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Urinalysis sample taken - Not Done
    Description

    Urinalysis sample taken - Not Done

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,3]
    C1272696 (Not Done)
    SNOMED
    385660001
    Haem Lab type code
    Description

    Haem Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Chem Lab type code
    Description

    Chem Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005774 (Blood Chemical Analysis)
    SNOMED
    166312007
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Urin Lab type code
    Description

    Urin Lab type code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    UMLS CUI [1,2]
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    UMLS CUI [1,3]
    C0805701 (Code)
    Liver Event Assessment
    Description

    Liver Event Assessment

    Alias
    UMLS CUI-1
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI-2
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-3
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Description

    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [1,2]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,3]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    UMLS CUI [1,4]
    C0304229 (Experimental drug)
    UMLS CUI [1,5]
    C2746065 (Stop (qualifier value))
    SNOMED
    422117008
    UMLS CUI [1,6]
    C0243161 (criteria)
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    Similar models

    Visit 2 - Run-In Failure; Randomisation Number; Electronically Transferred Lab Data; Liver Assessment

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Run-In Failure
    C1710476 (UMLS CUI-1)
    Was this subject a run-in failure?
    Item
    Was this subject a run-in failure?
    boolean
    C1710476 (UMLS CUI [1])
    Run-in failure date
    Item
    Run-in failure date
    date
    C1710476 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Run-in failure primary reason
    integer
    C1710476 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Run-in failure primary reason
    Code List
    Run-in failure primary reason
    CL Item
    Adverse event  (1)
    CL Item
    Protocol deviation  (3)
    CL Item
    Study closed/terminated  (5)
    CL Item
    Withdrew consent, specify (8)
    CL Item
    Did not meet continuation criteria  (9)
    CL Item
    Did not meet joint counts criteria (096)
    Item Group
    Randomisation Number
    C0034656 (UMLS CUI-1)
    C0237753 (UMLS CUI-2)
    Was the subject able to be randomised?
    Item
    Was the subject able to be randomised?
    boolean
    C0034656 (UMLS CUI [1])
    Randomisation number
    Item
    Randomisation number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of randomisation
    Item
    Date of randomisation
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Electronically Transferred Lab Data
    C0745590 (UMLS CUI-1)
    C1705822 (UMLS CUI-2)
    Haematology Date sample taken
    Item
    Haematology Date sample taken
    date
    C0018941 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Item
    Haematology sample taken - Not Done
    text
    C0005834 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Haematology sample taken - Not Done
    Code List
    Haematology sample taken - Not Done
    CL Item
    Not Done (ND)
    Biochemistry Date sample taken
    Item
    Biochemistry Date sample taken
    date
    C0005477 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Item
    Biochemistry sample taken - Not Done
    text
    C0005834 (UMLS CUI [1,1])
    C0005477 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Biochemistry sample taken - Not Done
    Code List
    Biochemistry sample taken - Not Done
    CL Item
    Not Done (ND)
    Urinalysis Date sample taken
    Item
    Urinalysis Date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    Item
    Urinalysis sample taken - Not Done
    text
    C0005834 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis sample taken - Not Done
    Code List
    Urinalysis sample taken - Not Done
    CL Item
    Not Done (ND)
    Haem Lab type code
    Item
    Haem Lab type code
    text
    C0018941 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Chem Lab type code
    Item
    Chem Lab type code
    text
    C0005774 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Urin Lab type code
    Item
    Urin Lab type code
    text
    C0042014 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Item Group
    Liver Event Assessment
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [1,4])
    C2746065 (UMLS CUI [1,5])
    C0243161 (UMLS CUI [1,6])
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