ID

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

Keywords

Versions (1)
  1. 3/18/20 3/18/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 18, 2020

DOI

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License

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
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
Run-in failure date
Description

Run-in failure date

Data type

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Run-in failure primary reason
Description

Run-in failure primary reason

Data type

integer

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Was the subject able to be randomised?

Data type

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation number
Description

Randomisation number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Description

Date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date sample taken
Description

Haematology Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1302413
Haematology sample taken - Not Done
Description

Haematology sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1272696
Biochemistry Date sample taken
Description

Biochemistry Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1302413
Biochemistry sample taken - Not Done
Description

Biochemistry sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005477
UMLS CUI [1,3]
C1272696
Urinalysis Date sample taken
Description

Urinalysis Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042014
Urinalysis sample taken - Not Done
Description

Urinalysis sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1272696
Haem Lab type code
Description

Haem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Chem Lab type code
Description

Chem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Description

Urin Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Liver Event Assessment
Description

Liver Event Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
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
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0243161
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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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