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ID

40243

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. 3/24/20 3/24/20 -
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GlaxoSmithKline

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March 24, 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

    End of Double Blind - Administrative; Subject Continuation; Phase Conclusion

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [1,2]
    C2985720 (Assessment Date)
    Subject Continuation
    Description

    Subject Continuation

    Alias
    UMLS CUI-1
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Is the subject continuing in the study?
    Description

    If the subject is an early withdrawal, tick No for subject continuation If yes, complete the Phase conclusion section and proceed with the Open-label Period If No, complete the Phase conclusion section and proceed with the Follow-up Period

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Phase Conclusion
    Description

    Phase Conclusion

    Alias
    UMLS CUI-1
    C1707478 (Conclusion)
    UMLS CUI-2
    C0205390 (Phase)
    SNOMED
    21191007
    Did the subject fail to complete this phase of the study?
    Description

    If yes, complete date and primary reason for withdrawal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0805732 (Completion Status)
    UMLS CUI [1,2]
    C0231175 (Failed)
    UMLS CUI [2,1]
    C0205390 (Phase)
    SNOMED
    21191007
    UMLS CUI [2,2]
    C2603343 (Study)
    Date subject failed to complete
    Description

    Date subject failed to complete

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0805732 (Completion Status)
    UMLS CUI [1,2]
    C0231175 (Failed)
    UMLS CUI [2,1]
    C0205390 (Phase)
    SNOMED
    21191007
    UMLS CUI [2,2]
    C2603343 (Study)
    UMLS CUI [3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Primary reason for withdrawal
    Description

    Primary reason for withdrawal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Specify Investigator discretion
    Description

    Specify Investigator discretion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348235 (Specification)
    UMLS CUI [1,2]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,3]
    C0022423 (Judgment)
    SNOMED
    61254005
    Specify withdrew consent
    Description

    Specify withdrew consent

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1707492 (Consent Withdrawn)
    UMLS CUI [1,2]
    C2348235 (Specification)
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    Similar models

    End of Double Blind - Administrative; Subject Continuation; Phase Conclusion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Date of Visit/ Assessment
    Item
    Date of Visit/ Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Subject Continuation
    C0805733 (UMLS CUI-1)
    Is the subject continuing in the study?
    Item
    Is the subject continuing in the study?
    boolean
    C0805733 (UMLS CUI [1])
    Item Group
    Phase Conclusion
    C1707478 (UMLS CUI-1)
    C0205390 (UMLS CUI-2)
    Did the subject fail to complete this phase of the study?
    Item
    Did the subject fail to complete this phase of the study?
    boolean
    C0805732 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C0205390 (UMLS CUI [2,1])
    C2603343 (UMLS CUI [2,2])
    Date subject failed to complete
    Item
    Date subject failed to complete
    date
    C0805732 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C0205390 (UMLS CUI [2,1])
    C2603343 (UMLS CUI [2,2])
    C0011008 (UMLS CUI [3])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol deviation (3)
    CL Item
    Subject reached protocol-defined stopping criteria (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to follow-up (6)
    CL Item
    Investigator discretion, specify (7)
    CL Item
    Withdrew consent, specify (8)
    CL Item
    Prohibited medication use  (029)
    Specify Investigator discretion
    Item
    Specify Investigator discretion
    text
    C2348235 (UMLS CUI [1,1])
    C0008961 (UMLS CUI [1,2])
    C0022423 (UMLS CUI [1,3])
    Specify withdrew consent
    Item
    Specify withdrew consent
    text
    C1707492 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Back to the top of the page 

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