ID
40246
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
Versionen (2)
- 24.03.20 24.03.20 -
- 24.03.20 24.03.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. 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
Unscheduled - PK Blood Sample; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score
Beschreibung
Tender Joint Count Page 1
Alias
- UMLS CUI-1
- C0451530
Beschreibung
Joint Pain/ Tenderness
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
Beschreibung
Joint Pain/Tenderness Finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
- UMLS CUI [1,3]
- C0243095
Beschreibung
Tender Joint Count Page 2
Alias
- UMLS CUI-1
- C0451530
Beschreibung
Joint Pain/ Tenderness
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
Beschreibung
Joint Pain/Tenderness Finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
- UMLS CUI [1,3]
- C0243095
Beschreibung
Joint Assessor Initials - Joint Pain/Tenderness
Alias
- UMLS CUI-1
- C2986440
- UMLS CUI-2
- C0240094
- UMLS CUI-3
- C0220825
- UMLS CUI-4
- C0240094
- UMLS CUI-5
- C0003862
Beschreibung
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2,1]
- C0240094
- UMLS CUI [2,2]
- C0003862
Beschreibung
Calculations - Joint Pain/Tenderness
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0240094
- UMLS CUI-3
- C0003862
Beschreibung
Tender/Painful joint count (based on 68 joint count)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0451530
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
Beschreibung
Total number of tender/painful joints assessed (based on 68 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0220825
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C0237753
- UMLS CUI [2,4]
- C0220825
Beschreibung
Tender/Painful joint count subset (based on 28 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C1515021
Beschreibung
Total number of tender/painful joints assessed subset (based on 28 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C0220825
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C1515021
- UMLS CUI [2,4]
- C0237753
- UMLS CUI [2,5]
- C0220825
Beschreibung
Swollen Joint Count Page 1
Alias
- UMLS CUI-1
- C0451521
Beschreibung
Joint Swelling
Datentyp
text
Alias
- UMLS CUI [1]
- C0152031
Beschreibung
Joint Swelling Finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beschreibung
Swollen Joint Count Page 2
Alias
- UMLS CUI-1
- C0451521
Beschreibung
Joint Swelling
Datentyp
integer
Alias
- UMLS CUI [1]
- C0152031
Beschreibung
Joint Swelling Finding
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beschreibung
Joint Assessor Initials - Joint Swelling
Alias
- UMLS CUI-1
- C2986440
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0152031
Beschreibung
Calculations - Joint Swelling
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0152031
Beschreibung
Swollen joint count (based on 66 joint count)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0451521
Beschreibung
Total number of swollen joints assessed (based on 66 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0220825
Beschreibung
Swollen joint count subset (based on 28 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
Beschreibung
Total number of swollen joints assessed subset (based on 28 joint count)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C0220825
Beschreibung
Swollen/ Tender Joint Count
Alias
- UMLS CUI-1
- C0451521
- UMLS CUI-2
- C0451530
Beschreibung
Pain Assessment VAS Score
Alias
- UMLS CUI-1
- C1161170
- UMLS CUI-2
- C0042815
Beschreibung
Pain Assessment VAS Score - Assessment Date
Datentyp
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
Beschreibung
Pain Assessment VAS Score
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1161170
- UMLS CUI [1,2]
- C0042815
Beschreibung
Pain Assessment VAS Score - ISO Language code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1161170
- UMLS CUI [1,2]
- C0042815
- UMLS CUI [2]
- C1708640
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
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
Beschreibung
VAS Score
Datentyp
integer
Alias
- UMLS CUI [1]
- C2960751
Beschreibung
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
Datentyp
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
Beschreibung
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
Beschreibung
Physician's Global Assessment of 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 [1,4]
- C0031831
- UMLS CUI [2]
- C2985720
Beschreibung
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0003864
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0449820
- UMLS CUI [1,4]
- C0031831
Beschreibung
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
Datentyp
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
Ähnliche Modelle
Unscheduled - PK Blood Sample; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0240094 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0240094 (UMLS CUI-4)
C0003862 (UMLS CUI-5)
C0220825 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0003862 (UMLS CUI [2,2])
C0240094 (UMLS CUI-2)
C0003862 (UMLS CUI-3)
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0220825 (UMLS CUI [2,4])
C1515021 (UMLS CUI [1,2])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
C0237753 (UMLS CUI [2,4])
C0220825 (UMLS CUI [2,5])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0152031 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C0152031 (UMLS CUI [2])
C0152031 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C1515021 (UMLS CUI [1,2])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0451530 (UMLS CUI-2)
C0451530 (UMLS CUI [1,2])
C0042815 (UMLS CUI-2)
C0042815 (UMLS CUI [1,2])
C1161170 (UMLS CUI [2,1])
C0042815 (UMLS CUI [2,2])
C2985720 (UMLS CUI [2,3])
C0042815 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,2])
C1708640 (UMLS CUI [2])
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2])
C0003864 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C2985720 (UMLS CUI [2])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])