ID

40254

Descripción

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

Palabras clave

  1. 25/3/20 25/3/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de marzo de 2020

DOI

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Licencia

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

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

ESR
Descripción

ESR

Alias
UMLS CUI-1
C1176468
ESR Date
Descripción

ESR Date

Tipo de datos

date

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

ESR

Tipo de datos

integer

Alias
UMLS CUI [1]
C1176468
ESR numeric result
Descripción

ESR numeric result

Tipo de datos

integer

Unidades de medida
  • mm/h
Alias
UMLS CUI [1,1]
C1176468
UMLS CUI [1,2]
C2347373
mm/h
PK Blood Sample - Point in Time Collection
Descripción

PK Blood Sample - Point in Time Collection

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

Sample taken before infusion?

Tipo de datos

boolean

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

Sample taken - Actual date and time

Tipo de datos

datetime

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

Sample taken - Sample Identifier/ Sample Number

Tipo de datos

text

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

PK Type Code

Tipo de datos

text

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

Biomarker Samples

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

Has sample been collected?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

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

If sample has not been collected, provide reason

Tipo de datos

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
Descripción

If other reason for sample has not been collected, specify

Tipo de datos

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
Descripción

Sample Type

Tipo de datos

text

Alias
UMLS CUI [1]
C2347029
Sample Number
Descripción

Sample Number

Tipo de datos

text

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

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?
Descripción

Has a blood sample been collected for transcriptomic research?

Tipo de datos

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
Descripción

Transcriptomic Research - Date and time sample taken

Tipo de datos

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
Descripción

PGm-T Type

Tipo de datos

text

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

Transcriptomic Research - Sample Type

Tipo de datos

text

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

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?
Descripción

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

Tipo de datos

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
Descripción

Investigational Product Discontinuation

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

If yes, complete primary reason

Tipo de datos

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
Descripción

Date of early investigational product withdrawal

Tipo de datos

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
Descripción

Select primary reason the investigational product was stopped

Tipo de datos

integer

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

Specify investigator discretion

Tipo de datos

text

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

Specify withdrew consent

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])
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])
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])

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