ID

40244

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. 3/24/20 3/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 24, 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

Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment

1 forms  
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 take

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
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
ESR
Description

ESR

Alias
UMLS CUI-1
C1176468
ESR Date
Description

ESR Date

Data type

date

Alias
UMLS CUI [1,1]
C1176468
UMLS CUI [1,2]
C0011008
ESR
Description

ESR

Data type

integer

Alias
UMLS CUI [1]
C1176468
ESR numeric result
Description

ESR numeric result

Data type

integer

Measurement units
  • mm/h
Alias
UMLS CUI [1,1]
C1176468
UMLS CUI [1,2]
C2347373
mm/h
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Description

If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2349155
UMLS CUI [1,3]
C0037088
UMLS CUI [1,4]
C0023524
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure diastolic Blood pressure diastolic
Description

Blood pressure diastolic Blood pressure diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Description

Position should be consistent throughout the study

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Description

Location should be consistent throughout the study

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
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?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

Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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 take
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])
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
ESR
C1176468 (UMLS CUI-1)
ESR Date
Item
ESR Date
date
C1176468 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ESR
integer
C1176468 (UMLS CUI [1])
ESR
Code List
ESR
CL Item
Numeric result  (97)
CL Item
No result (99)
ESR numeric result
Item
ESR numeric result
integer
C1176468 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Item
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
boolean
C0027853 (UMLS CUI [1,1])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic Blood pressure diastolic
Item
Blood pressure diastolic Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral  (1)
CL Item
Rectal  (2)
CL Item
Axilla  (3)
CL Item
Tympanic  (4)
CL Item
Intra-arterial (5)
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?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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