ID

40156

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. 3/18/20 3/18/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 18, 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

Visit 2 - Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score

Pain Assessment VAS Score
Description

Pain Assessment VAS Score

Alias
UMLS CUI-1
C1161170
UMLS CUI-2
C0042815
Pain Assessment VAS Score - Assessment Date
Description

Pain Assessment VAS Score - Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1161170
UMLS CUI [1,2]
C0042815
UMLS CUI [2,1]
C1161170
UMLS CUI [2,2]
C0042815
UMLS CUI [2,3]
C2985720
Pain Assessment VAS Score
Description

Pain Assessment VAS Score

Data type

integer

Alias
UMLS CUI [1,1]
C1161170
UMLS CUI [1,2]
C0042815
Pain Assessment VAS Score - ISO Language code
Description

Pain Assessment VAS Score - ISO Language code

Data type

text

Alias
UMLS CUI [1,1]
C1161170
UMLS CUI [1,2]
C0042815
UMLS CUI [2]
C1708640
Patient's Global Assessment of Arthritis Condition VAS Score
Description

Patient's Global Assessment of Arthritis Condition VAS Score

Alias
UMLS CUI-1
C0281858
UMLS CUI-2
C0003864
UMLS CUI-3
C0449438
UMLS CUI-4
C0449820
Arthritis Condition VAS Score - Assessment Date
Description

Arthritis Condition VAS Score - Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0449820
UMLS CUI [2]
C2985720
VAS Score
Description

VAS Score

Data type

integer

Alias
UMLS CUI [1]
C2960751
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
Description

Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code

Data type

text

Alias
UMLS CUI [1,1]
C0281858
UMLS CUI [1,2]
C0003864
UMLS CUI [1,3]
C0449438
UMLS CUI [1,4]
C0449820
UMLS CUI [2]
C1708640
Physician's Global Assessment of Arthritis Condition VAS Score
Description

Physician's Global Assessment of Arthritis Condition VAS Score

Alias
UMLS CUI-1
C0281858
UMLS CUI-2
C0003864
UMLS CUI-3
C0449438
UMLS CUI-4
C0449820
UMLS CUI-5
C0031831
Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
Description

Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0449820
UMLS CUI [1,4]
C0031831
UMLS CUI [2]
C2985720
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
Description

Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score

Data type

integer

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0449820
UMLS CUI [1,4]
C0031831
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
Description

Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code

Data type

text

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0449820
UMLS CUI [1,4]
C0031831
UMLS CUI [2]
C1708640

Similar models

Visit 2 - Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pain Assessment VAS Score
C1161170 (UMLS CUI-1)
C0042815 (UMLS CUI-2)
Pain Assessment VAS Score - Assessment Date
Item
Pain Assessment VAS Score - Assessment Date
date
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C1161170 (UMLS CUI [2,1])
C0042815 (UMLS CUI [2,2])
C2985720 (UMLS CUI [2,3])
Pain Assessment VAS Score
Item
Pain Assessment VAS Score
integer
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
Item
Pain Assessment VAS Score - ISO Language code
text
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C1708640 (UMLS CUI [2])
Code List
Pain Assessment VAS Score - ISO Language code
CL Item
Danish  (DAN)
CL Item
English  (ENG)
CL Item
Finnish  (FIN)
CL Item
French  (FRE)
CL Item
German  (GER)
CL Item
Italian  (ITA)
CL Item
Korean  (KOR)
CL Item
Norwegian  (NOR)
CL Item
Spanish  (SPA)
CL Item
Swedish  (SWE)
CL Item
Dutch  (DUT)
CL Item
Portuguese (POR)
Item Group
Patient's Global Assessment of Arthritis Condition VAS Score
C0281858 (UMLS CUI-1)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
Arthritis Condition VAS Score - Assessment Date
Item
Arthritis Condition VAS Score - Assessment Date
date
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2])
VAS Score
Item
VAS Score
integer
C2960751 (UMLS CUI [1])
Item
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
text
C0281858 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
Code List
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
CL Item
Danish  (DAN)
CL Item
English  (ENG)
CL Item
Finnish  (FIN)
CL Item
French  (FRE)
CL Item
German  (GER)
CL Item
Italian  (ITA)
CL Item
Korean  (KOR)
CL Item
Norwegian  (NOR)
CL Item
Spanish  (SPA)
CL Item
Swedish  (SWE)
CL Item
Dutch; Flemish  (DUT)
CL Item
Portuguese  (POR)
CL Item
Afrikaans  (AFR)
CL Item
Czech  (CES)
CL Item
Chinese  (CHI)
CL Item
Hungarian  (HUN)
CL Item
Lithuanian  (LIT)
CL Item
Polish  (POL)
CL Item
Romanian  (RUM)
CL Item
Russian (RUS)
Item Group
Physician's Global Assessment of Arthritis Condition VAS Score
C0281858 (UMLS CUI-1)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
Item
Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
date
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C2985720 (UMLS CUI [2])
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
Item
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
integer
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
Item
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
text
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
Code List
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
CL Item
Danish  (DAN)
CL Item
English  (ENG)
CL Item
Finnish  (FIN)
CL Item
French  (FRE)
CL Item
German  (GER)
CL Item
Italian  (ITA)
CL Item
Korean  (KOR)
CL Item
Norwegian  (NOR)
CL Item
Spanish  (SPA)
CL Item
Swedish  (SWE)
CL Item
Dutch  (DUT)
CL Item
Portuguese (POR)

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