ID

40149

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

Versions (2)
  1. 3/16/20 3/16/20 -
  2. 3/17/20 3/17/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 17, 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

English

Screen - Administrative; Patient's Global Assessment of Arthritis Condition VAS Score; Demography

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Inform Enrollment
Description

Inform Enrollment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
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
ISO Language code
Description

ISO Language code

Data type

text

Alias
UMLS CUI [1]
C1708640
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C3841890
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Similar models

Screen - Administrative; Patient's Global Assessment of Arthritis Condition VAS Score; Demography

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrollment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
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
ISO Language code
text
C1708640 (UMLS CUI [1])
ISO Language code
Code List
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
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
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