ID

40254

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2020-03-25 2020-03-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 mars 2020

DOI

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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

Engelsk

Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

1 Formulär  
ESR
Beskrivning

ESR

Alias
UMLS CUI-1
C1176468
ESR Date
Beskrivning

ESR Date

Datatyp

date

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

ESR

Datatyp

integer

Alias
UMLS CUI [1]
C1176468
ESR numeric result
Beskrivning

ESR numeric result

Datatyp

integer

Måttenheter
  • mm/h
Alias
UMLS CUI [1,1]
C1176468
UMLS CUI [1,2]
C2347373
mm/h
PK Blood Sample - Point in Time Collection
Beskrivning

PK Blood Sample - Point in Time Collection

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

Sample taken before infusion?

Datatyp

boolean

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

Sample taken - Actual date and time

Datatyp

datetime

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

Sample taken - Sample Identifier/ Sample Number

Datatyp

text

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

PK Type Code

Datatyp

text

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

Biomarker Samples

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

Has sample been collected?

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beskrivning

Date sample taken

Datatyp

date

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

If sample has not been collected, provide reason

Datatyp

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
Beskrivning

If other reason for sample has not been collected, specify

Datatyp

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
Beskrivning

Sample Type

Datatyp

text

Alias
UMLS CUI [1]
C2347029
Sample Number
Beskrivning

Sample Number

Datatyp

text

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

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?
Beskrivning

Has a blood sample been collected for transcriptomic research?

Datatyp

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
Beskrivning

Transcriptomic Research - Date and time sample taken

Datatyp

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
Beskrivning

PGm-T Type

Datatyp

text

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

Transcriptomic Research - Sample Type

Datatyp

text

Alias
UMLS CUI [1,1]
C3178810
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C2347029
Liver Event Assessment
Beskrivning

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?
Beskrivning

Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?

Datatyp

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
Investigational Product Discontinuation
Beskrivning

Investigational Product Discontinuation

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0457454
Was the subject withdrawn from future infusions of investigational product?
Beskrivning

If yes, complete primary reason

Datatyp

boolean

Alias
UMLS CUI [1]
C0422727
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0016884
UMLS CUI [3]
C0304229
Date of early investigational product withdrawal
Beskrivning

Date of early investigational product withdrawal

Datatyp

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0011008
Select primary reason the investigational product was stopped
Beskrivning

Select primary reason the investigational product was stopped

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0457454
Specify investigator discretion
Beskrivning

Specify investigator discretion

Datatyp

text

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

Specify withdrew consent

Datatyp

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
Tillbaka till toppen

Similar models

Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
Item Group
Investigational Product Discontinuation
C0304229 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Was the subject withdrawn from future infusions of investigational product?
Item
Was the subject withdrawn from future infusions of investigational product?
boolean
C0422727 (UMLS CUI [1])
C0574032 (UMLS CUI [2,1])
C0016884 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
Date of early investigational product withdrawal
Item
Date of early investigational product withdrawal
date
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Select primary reason the investigational product was stopped
integer
C0392360 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
Select primary reason the investigational product was stopped
Code List
Select primary reason the investigational product was stopped
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  (002)
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])
Tillbaka till toppen 

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