ID
40244
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)
- 24-03-20 24-03-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 maart 2020
DOI
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Licentie
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
Beschrijving
ESR
Alias
- UMLS CUI-1
- C1176468
Beschrijving
ESR Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C0011008
Beschrijving
ESR
Datatype
integer
Alias
- UMLS CUI [1]
- C1176468
Beschrijving
ESR numeric result
Datatype
integer
Maateenheden
- mm/h
Alias
- UMLS CUI [1,1]
- C1176468
- UMLS CUI [1,2]
- C2347373
Beschrijving
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2349155
- UMLS CUI [1,3]
- C0037088
- UMLS CUI [1,4]
- C0023524
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Blood pressure systolic
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure diastolic Blood pressure diastolic
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Position should be consistent throughout the study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Location should be consistent throughout the study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2826699
- UMLS CUI [1,2]
- C0039476
Beschrijving
Liver Event Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beschrijving
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?
Datatype
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
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Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment
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C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
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