ID

40149

Beschreibung

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

Stichworte

  1. 16.03.20 16.03.20 -
  2. 17.03.20 17.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. März 2020

DOI

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Lizenz

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

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

Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Inform Enrollment
Beschreibung

Inform Enrollment

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

Subject Number

Datentyp

text

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

Date of Visit/ Assessment

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

Date of Visit/ Assessment

Datentyp

date

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

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Patient's Global Assessment of Arthritis Condition VAS Score
Beschreibung

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
Beschreibung

Arthritis Condition VAS Score - Assessment Date

Datentyp

date

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

VAS Score

Datentyp

integer

Alias
UMLS CUI [1]
C2960751
ISO Language code
Beschreibung

ISO Language code

Datentyp

text

Alias
UMLS CUI [1]
C1708640
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1]
C3841890

Ähnliche Modelle

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

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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])
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
text
C3841890 (UMLS CUI [1])
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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