ID

40158

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. 18-03-20 18-03-20 -
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GlaxoSmithKline

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18 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

Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing

1 Formulieren  
Biomarker Samples
Beschrijving

Biomarker Samples

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

Has sample been collected?

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beschrijving

Date sample taken

Datatype

date

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

If sample has not been collected, provide reason

Datatype

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
Beschrijving

If other reason for sample has not been collected, specify

Datatype

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
Beschrijving

Sample Type

Datatype

text

Alias
UMLS CUI [1]
C2347029
Sample Number
Beschrijving

Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222
Pharmacogenetic Research Consent/ Blood Sample Collection
Beschrijving

Pharmacogenetic Research Consent/ Blood Sample Collection

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
UMLS CUI-4
C0005834
Has informed consent been obtained for PGx research?
Beschrijving

Has informed consent been obtained for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
Date informed consent obtained for PGx research
Beschrijving

Date informed consent obtained for PGx research

Datatype

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
Has blood been collected for PGx research?
Beschrijving

Has blood been collected for PGx research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Reason for informed consent has not been obtained for PGx research
Beschrijving

Reason for informed consent has not been obtained for PGx research

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
If other reason for informed consent has not been obtained for PGx research, specify
Beschrijving

If other reason for informed consent has not been obtained for PGx research, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C2826287
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Pharmacogenetics - Sample Type
Beschrijving

Pharmacogenetics - Sample Type

Datatype

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C2347029
Transcriptomic Research Sample Collection Details
Beschrijving

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?
Beschrijving

Has a blood sample been collected for transcriptomic research?

Datatype

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
Beschrijving

Transcriptomic Research - Date and time sample taken

Datatype

datetime

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
Beschrijving

PGm-T Type

Datatype

text

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

Transcriptomic Research - Sample Type

Datatype

text

Alias
UMLS CUI [1,1]
C3178810
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C2347029
PK Blood Sample - Before Infusion
Beschrijving

PK Blood Sample - Before Infusion

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-4
C0585032
UMLS CUI-5
C0574032
Sample taken before infusion?
Beschrijving

Sample taken before infusion?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0585032
UMLS CUI [2,2]
C0574032
Sample taken before infusion - Actual date and time
Beschrijving

Sample taken before infusion - Actual date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0585032
UMLS CUI [2,2]
C0574032
UMLS CUI [3]
C1264639
Sample taken before infusion - Sample Identifier/ Sample Number
Beschrijving

Sample taken before infusion - Sample Identifier/ Sample Number

Datatype

text

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0585032
UMLS CUI [2,2]
C0574032
UMLS CUI [3]
C1299222
PK Blood Sample - End of Infusion
Beschrijving

PK Blood Sample - End of Infusion

Alias
UMLS CUI-1
C0201734
UMLS CUI-2
C0178913
UMLS CUI-3
C0444930
UMLS CUI-4
C0574032
Sample taken at end of infusion?
Beschrijving

Sample taken at end of infusion?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0574032
Sample taken at end of infusion - Actual date and time
Beschrijving

Sample taken at end of infusion - Actual date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0574032
UMLS CUI [3]
C1264639
Sample taken at end of infusion - Sample Identifier/ Sample Number
Beschrijving

Sample taken at end of infusion - Sample Identifier/ Sample Number

Datatype

text

Alias
UMLS CUI [1,1]
C0201734
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0444930
UMLS CUI [2,2]
C0574032
UMLS CUI [3]
C1299222
PK Type Code
Beschrijving

PK Type Code

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0332307
UMLS CUI-3
C0805701
PK Type Code
Beschrijving

PK Type Code

Datatype

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0805701
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Actual date/time
Beschrijving

Vital Signs - Actual date/time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Beschrijving

Systolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beschrijving

Position should be consistent throughout the study

Datatype

integer

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

Heart rate

Datatype

text

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beschrijving

Location should be consistent throughout the study

Datatype

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Investigational Product - IV Dosing
Beschrijving

Investigational Product - IV Dosing

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0678766
UMLS CUI-3
C0348016
Investigational Product - Sequence Number
Beschrijving

Investigational Product - Sequence Number

Datatype

integer

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C2348184
Investigational product code
Beschrijving

Investigational product code

Datatype

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0304229
Investigational product - Start date and time
Beschrijving

Investigational product - Start date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0304229
Investigational product - Stop date and time
Beschrijving

Investigational product - Stop date and time

Datatype

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C0304229
Was dose interrupted?
Beschrijving

Was dose interrupted?

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1512900
Primary reason for interruption
Beschrijving

Primary reason for interruption

Datatype

text

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1512900
UMLS CUI [2]
C0392360
Rate of Infusion
Beschrijving

Rate of Infusion

Datatype

integer

Maateenheden
  • mL/h
Alias
UMLS CUI [1]
C2964135
mL/h
Rate of infusion unit
Beschrijving

Rate of infusion unit

Datatype

text

Alias
UMLS CUI [1,1]
C2964135
UMLS CUI [1,2]
C1519795
Total Volume of Infusion unit
Beschrijving

Total Volume of Infusion unit

Alias
UMLS CUI-1
C0574032
UMLS CUI-2
C2700258
UMLS CUI-3
C0439810
Total volume of infusion administered
Beschrijving

Total volume of infusion administered

Datatype

integer

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0439810
mL
Was the total volume of infusion administered?
Beschrijving

Was the total volume of infusion administered?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0574032
UMLS CUI [1,2]
C0449468
UMLS CUI [1,3]
C0439810
Primary reason for stoppage?
Beschrijving

Primary reason for stoppage?

Datatype

text

Alias
UMLS CUI [1]
C0574032
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1947925
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Similar models

Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
Pharmacogenetic Research Consent/ Blood Sample Collection
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
C0005834 (UMLS CUI-4)
Has informed consent been obtained for PGx research?
Item
Has informed consent been obtained for PGx research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained for PGx research
Item
Date informed consent obtained for PGx research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has blood been collected for PGx research?
Item
Has blood been collected for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Reason for informed consent has not been obtained for PGx research
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
Reason for informed consent has not been obtained for PGx research
Code List
Reason for informed consent has not been obtained for PGx research
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (Z)
If other reason for informed consent has not been obtained for PGx research, specify
Item
If other reason for informed consent has not been obtained for PGx research, specify
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Pharmacogenetics - Sample Type
Item
Pharmacogenetics - Sample Type
text
C0031325 (UMLS CUI [1,1])
C2347029 (UMLS CUI [1,2])
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
datetime
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
PK Blood Sample - Before Infusion
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0585032 (UMLS CUI-4)
C0574032 (UMLS CUI-5)
Sample taken before infusion?
Item
Sample taken before infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken before infusion - Actual date and time
Item
Sample taken before infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken before infusion - Sample Identifier/ Sample Number
Item
Sample taken before infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0585032 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
Item Group
PK Blood Sample - End of Infusion
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
C0574032 (UMLS CUI-4)
Sample taken at end of infusion?
Item
Sample taken at end of infusion?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
Sample taken at end of infusion - Actual date and time
Item
Sample taken at end of infusion - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1264639 (UMLS CUI [3])
Sample taken at end of infusion - Sample Identifier/ Sample Number
Item
Sample taken at end of infusion - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
C0574032 (UMLS CUI [2,2])
C1299222 (UMLS CUI [3])
Item Group
PK Type Code
C0031328 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
C0805701 (UMLS CUI-3)
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
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Actual date/time
Item
Vital Signs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
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
text
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
Investigational Product - IV Dosing
C0304229 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
Investigational Product - Sequence Number
Item
Investigational Product - Sequence Number
integer
C0304229 (UMLS CUI [1])
C2348184 (UMLS CUI [2])
Investigational product code
Item
Investigational product code
text
C0304229 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Start date and time
Item
Investigational product - Start date and time
datetime
C3897500 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product - Stop date and time
Item
Investigational product - Stop date and time
datetime
C3899266 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Was dose interrupted?
Item
Was dose interrupted?
boolean
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Item
Primary reason for interruption
text
C3174092 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Primary reason for interruption
Code List
Primary reason for interruption
CL Item
Adverse event (13)
CL Item
Dosing error  (4)
CL Item
Subject non-compliance  (7)
CL Item
Mechanical problem  (8)
CL Item
Other, specify reason (OT)
Rate of Infusion
Item
Rate of Infusion
integer
C2964135 (UMLS CUI [1])
Rate of infusion unit
Item
Rate of infusion unit
text
C2964135 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item Group
Total Volume of Infusion unit
C0574032 (UMLS CUI-1)
C2700258 (UMLS CUI-2)
C0439810 (UMLS CUI-3)
Total volume of infusion administered
Item
Total volume of infusion administered
integer
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Was the total volume of infusion administered?
Item
Was the total volume of infusion administered?
boolean
C0574032 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Primary reason for stoppage?
text
C0574032 (UMLS CUI [1])
C0392360 (UMLS CUI [2,1])
C1947925 (UMLS CUI [2,2])
Primary reason for stoppage?
Code List
Primary reason for stoppage?
CL Item
Adverse event  (13)
CL Item
Dosing error  (4)
CL Item
Subject non-compliance  (7)
CL Item
Mechanical problem  (8)
CL Item
Other, Specify (OT)
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