ID
40151
Beskrivning
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
Nyckelord
Versioner (1)
- 2020-03-17 2020-03-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 mars 2020
DOI
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Licens
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 - Chest X-Ray; Tender Joint Count; Swollen Joint Count; Electronically Transferred Lab Data; ESR
Beskrivning
Tender Joint Count Page 1
Alias
- UMLS CUI-1
- C0451530
Beskrivning
Joint Pain/ Tenderness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
Beskrivning
Joint Pain/Tenderness Finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
- UMLS CUI [1,3]
- C0243095
Beskrivning
Tender Joint Count Page 2
Alias
- UMLS CUI-1
- C0451530
Beskrivning
Joint Pain/ Tenderness
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
Beskrivning
Joint Pain/Tenderness Finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
- UMLS CUI [1,3]
- C0243095
Beskrivning
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
Beskrivning
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2,1]
- C0240094
- UMLS CUI [2,2]
- C0003862
Beskrivning
Calculations - Joint Pain/Tenderness
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0240094
- UMLS CUI-3
- C0003862
Beskrivning
Tender/Painful joint count (based on 68 joint count)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451530
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
Beskrivning
Total number of tender/painful joints assessed (based on 68 joint count)
Datatyp
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
Beskrivning
Tender/Painful joint count subset (based on 28 joint count)
Datatyp
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
Beskrivning
Total number of tender/painful joints assessed subset (based on 28 joint count)
Datatyp
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
Beskrivning
Swollen Joint Count Page 1
Alias
- UMLS CUI-1
- C0451521
Beskrivning
Joint Swelling
Datatyp
text
Alias
- UMLS CUI [1]
- C0152031
Beskrivning
Joint Swelling Finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beskrivning
Swollen Joint Count Page 2
Alias
- UMLS CUI-1
- C0451521
Beskrivning
Joint Swelling
Datatyp
integer
Alias
- UMLS CUI [1]
- C0152031
Beskrivning
Joint Swelling Finding
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beskrivning
Joint Assessor Initials - Joint Swelling
Alias
- UMLS CUI-1
- C2986440
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0152031
Beskrivning
Calculations - Joint Swelling
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0152031
Beskrivning
Swollen joint count (based on 66 joint count)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0451521
Beskrivning
Total number of swollen joints assessed (based on 66 joint count)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0220825
Beskrivning
Swollen joint count subset (based on 28 joint count)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
Beskrivning
Total number of swollen joints assessed subset (based on 28 joint count)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C0220825
Beskrivning
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beskrivning
Haematology Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1302413
Beskrivning
Haematology sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1272696
Beskrivning
Biochemistry Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0005477
- UMLS CUI [1,2]
- C1302413
Beskrivning
Biochemistry sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0005477
- UMLS CUI [1,3]
- C1272696
Beskrivning
Urinalysis Date sample taken
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0042014
Beskrivning
Urinalysis sample taken - Not Done
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C1272696
Beskrivning
Haem Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beskrivning
Chem Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beskrivning
Urin Lab type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beskrivning
ESR - Local Laboratory
Alias
- UMLS CUI-1
- C1176468
- UMLS CUI-2
- C0022885
Beskrivning
ESR Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C0011008
Beskrivning
ESR
Datatyp
integer
Alias
- UMLS CUI [1]
- C1176468
Beskrivning
ESR numeric result
Datatyp
integer
Måttenheter
- mm/h
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C2347373
Similar models
Screen - Chest X-Ray; Tender Joint Count; Swollen Joint Count; Electronically Transferred Lab Data; ESR
C0039985 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C3841220 (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])
C1705822 (UMLS CUI-2)
C1302413 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)