ID

40228

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 (3)
  1. 3/23/20 3/23/20 -
  2. 3/23/20 3/23/20 -
  3. 3/23/20 3/23/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 23, 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 4; 6; 9 - Electronically Transferred Lab Data; ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection Details; Liver Events

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
PK Blood Sample - Point in Time Collection
Description

PK Blood Sample - Point in Time Collection

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C1516698
Sample taken?
Description

Sample taken before infusion?

Data type

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
Sample taken - Actual date and time
Description

Sample taken - Actual date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2]
C1264639
Sample taken - Sample Identifier/ Sample Number
Description

Sample taken - Sample Identifier/ Sample Number

Data type

text

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2]
C1299222
PK Type Code
Description

PK Type Code

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0805701
Biomarker Samples
Description

Biomarker Samples

Alias
UMLS CUI-1
C0005516
UMLS CUI-2
C0370003
Has sample been collected?
Description

Has sample been collected?

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
If sample has not been collected, provide reason
Description

If sample has not been collected, provide reason

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C2826287
If other reason for sample has not been collected, specify
Description

If other reason for sample has not been collected, specify

Data type

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C2826287
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Sample Type
Description

Sample Type

Data type

text

Alias
UMLS CUI [1]
C2347029
Sample Number
Description

Sample Number

Data type

text

Alias
UMLS CUI [1]
C1299222
Transcriptomic Research Sample Collection Details
Description

Transcriptomic Research Sample Collection Details

Alias
UMLS CUI-1
C3178810
UMLS CUI-2
C0035168
UMLS CUI-3
C0005834
UMLS CUI-4
C1522508
Has a blood sample been collected for transcriptomic research?
Description

Has a blood sample been collected for transcriptomic research?

Data type

boolean

Alias
UMLS CUI [1,1]
C3178810
UMLS CUI [1,2]
C0035168
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C1522508
Transcriptomic Research - Date and time sample taken
Description

Transcriptomic Research - Date and time sample taken

Data type

date

Alias
UMLS CUI [1,1]
C3178810
UMLS CUI [1,2]
C0035168
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0200345
PGm-T Type
Description

PGm-T Type

Data type

text

Alias
UMLS CUI [1]
C1831759
Transcriptomic Research - Sample Type
Description

Transcriptomic Research - Sample Type

Data type

text

Alias
UMLS CUI [1,1]
C3178810
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C2347029
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 4; 6; 9 - Electronically Transferred Lab Data; ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection Details; Liver Events

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
PK Blood Sample - Point in Time Collection
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
Sample taken before infusion?
Item
Sample taken?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Sample taken - Actual date and time
Item
Sample taken - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Sample taken - Sample Identifier/ Sample Number
Item
Sample taken - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Biomarker Samples
C0005516 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
Has sample been collected?
Item
Has sample been collected?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If sample has not been collected, provide reason
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
If sample has not been collected, provide reason
Code List
If sample has not been collected, provide reason
CL Item
Subject not asked by investigator  (2)
CL Item
Other, specify (OT)
If other reason for sample has not been collected, specify
Item
If other reason for sample has not been collected, specify
text
C0200345 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Sample Type
Item
Sample Type
text
C2347029 (UMLS CUI [1])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Transcriptomic Research Sample Collection Details
C3178810 (UMLS CUI-1)
C0035168 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
Has a blood sample been collected for transcriptomic research?
Item
Has a blood sample been collected for transcriptomic research?
boolean
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
Transcriptomic Research - Date and time sample taken
Item
Transcriptomic Research - Date and time sample taken
date
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
PGm-T Type
Item
PGm-T Type
text
C1831759 (UMLS CUI [1])
Transcriptomic Research - Sample Type
Item
Transcriptomic Research - Sample Type
text
C3178810 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C2347029 (UMLS CUI [2])
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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