ID

40254

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

  1. 3/25/20 3/25/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 25, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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
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
Investigational Product Discontinuation
Description

Investigational Product Discontinuation

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Was the subject withdrawn from future infusions of investigational product?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

If yes, complete primary reason

Data type

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
Description

Date of early investigational product withdrawal

Data type

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
Description

Select primary reason the investigational product was stopped

Data type

integer

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

Specify investigator discretion

Data type

text

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

Specify withdrew consent

Data type

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
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial