ID

40247

Beschrijving

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

Trefwoorden

Versies (1)
  1. 24-03-20 24-03-20 -
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GlaxoSmithKline

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24 maart 2020

DOI

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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

Engels

Early Withdrawal - Administrative; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score; Vital Signs; ECG; Neurological Examination

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Date of Visit/ Assessment
Beschrijving

Date of Visit/ Assessment

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Pain Assessment VAS Score
Beschrijving

Pain Assessment VAS Score

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

Pain Assessment VAS Score - Assessment Date

Datatype

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
Beschrijving

Pain Assessment VAS Score

Datatype

integer

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

Pain Assessment VAS Score - ISO Language code

Datatype

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
Beschrijving

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
Beschrijving

Arthritis Condition VAS Score - Assessment Date

Datatype

date

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

VAS Score

Datatype

integer

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

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

Datatype

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
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Beschrijving

Weight

Datatype

integer

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood pressure systolic
Beschrijving

Blood pressure systolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure diastolic
Beschrijving

Blood pressure diastolic

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Beschrijving

Position should be consistent throughout the study

Datatype

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Beschrijving

Location should be consistent throughout the study

Datatype

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
ECG
Beschrijving

ECG

Alias
UMLS CUI-1
C1623258
Date of ECG
Beschrijving

Date of ECG

Datatype

date

Alias
UMLS CUI [1]
C2826640
Result of the ECG
Beschrijving

Result of the ECG

Datatype

integer

Alias
UMLS CUI [1]
C0438154
Was there a clinically significant change from baseline?
Beschrijving

Was there a clinically significant change from baseline?

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C2826293
UMLS CUI [1,4]
C1442488
Neurological Examination
Beschrijving

Neurological Examination

Alias
UMLS CUI-1
C0027853
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Beschrijving

If Yes record details on the Medical History or Serious Adverse Events forms as appropriate.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2349155
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0023524
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Similar models

Early Withdrawal - Administrative; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score; Vital Signs; ECG; Neurological Examination

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
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])
Pain Assessment VAS Score - ISO Language code
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])
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
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])
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
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)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Location of temperature
Code List
Location of temperature
CL Item
Oral  (1)
CL Item
Rectal  (2)
CL Item
Axilla  (3)
CL Item
Tympanic  (4)
CL Item
Intra-arterial (5)
Item Group
ECG
C1623258 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE/SAE form if clinically significant abnormalities meet the protocol definition for an AE/SAE) (3)
CL Item
No result (not available) (4)
Item
Was there a clinically significant change from baseline?
text
C1623258 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,4])
Was there a clinically significant change from baseline?
Code List
Was there a clinically significant change from baseline?
CL Item
No  (N)
CL Item
Yes  (Y)
CL Item
Not Applicable (X)
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Item
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
boolean
C0027853 (UMLS CUI [1,1])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
C0023524 (UMLS CUI [3])
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