ID
40244
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)
- 2020-03-24 2020-03-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 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
Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment
Beskrivning
ESR
Alias
- UMLS CUI-1
- C1176468
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
Beskrivning
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2349155
- UMLS CUI [1,3]
- C0037088
- UMLS CUI [1,4]
- C0023524
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Blood pressure systolic
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure diastolic Blood pressure diastolic
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Position should be consistent throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Location should be consistent throughout the study
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2826699
- UMLS CUI [1,2]
- C0039476
Beskrivning
Liver Event Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beskrivning
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0243161
Similar models
Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment
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])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
C0039476 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])