ID

40243

Beschrijving

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

Trefwoorden

Versies (1)
  1. 24-03-20 24-03-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 maart 2020

DOI

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Licentie

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

Engels

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

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Subject Continuation
Beschrijving

Subject Continuation

Alias
UMLS CUI-1
C0805733
Is the subject continuing in the study?
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0805733
Phase Conclusion
Beschrijving

Phase Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0205390
Did the subject fail to complete this phase of the study?
Beschrijving

If yes, complete date and primary reason for withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0205390
UMLS CUI [2,2]
C2603343
Date subject failed to complete
Beschrijving

Date subject failed to complete

Datatype

date

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0205390
UMLS CUI [2,2]
C2603343
UMLS CUI [3]
C0011008
Primary reason for withdrawal
Beschrijving

Primary reason for withdrawal

Datatype

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify Investigator discretion
Beschrijving

Specify Investigator discretion

Datatype

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Specify withdrew consent
Beschrijving

Specify withdrew consent

Datatype

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

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