ID
40158
Descripción
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
Palabras clave
Versiones (1)
- 18/3/20 18/3/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
18 de marzo de 2020
DOI
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Licencia
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
Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing
Descripción
Pharmacogenetic Research Consent/ Blood Sample Collection
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C2347500
- UMLS CUI-4
- C0005834
Descripción
Has informed consent been obtained for PGx research?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Descripción
Date informed consent obtained for PGx research
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Descripción
Has blood been collected for PGx research?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Descripción
Date sample taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
Reason for informed consent has not been obtained for PGx research
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C2826287
Descripción
If other reason for informed consent has not been obtained for PGx research, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C2826287
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Descripción
Pharmacogenetics - Sample Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0031325
- UMLS CUI [1,2]
- C2347029
Descripción
Transcriptomic Research Sample Collection Details
Alias
- UMLS CUI-1
- C3178810
- UMLS CUI-2
- C0035168
- UMLS CUI-3
- C0005834
- UMLS CUI-4
- C1522508
Descripción
Has a blood sample been collected for transcriptomic research?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3178810
- UMLS CUI [1,2]
- C0035168
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C1522508
Descripción
Transcriptomic Research - Date and time sample taken
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C3178810
- UMLS CUI [1,2]
- C0035168
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C0200345
Descripción
PGm-T Type
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1831759
Descripción
Transcriptomic Research - Sample Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3178810
- UMLS CUI [1,2]
- C0035168
- UMLS CUI [2]
- C2347029
Descripción
PK Blood Sample - Before Infusion
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-4
- C0585032
- UMLS CUI-5
- C0574032
Descripción
Sample taken before infusion?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
Descripción
Sample taken before infusion - Actual date and time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1264639
Descripción
Sample taken before infusion - Sample Identifier/ Sample Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0585032
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1299222
Descripción
PK Blood Sample - End of Infusion
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C0444930
- UMLS CUI-4
- C0574032
Descripción
Sample taken at end of infusion?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
Descripción
Sample taken at end of infusion - Actual date and time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1264639
Descripción
Sample taken at end of infusion - Sample Identifier/ Sample Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2,1]
- C0444930
- UMLS CUI [2,2]
- C0574032
- UMLS CUI [3]
- C1299222
Descripción
PK Type Code
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0332307
- UMLS CUI-3
- C0805701
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Vital Signs - Actual date/time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Descripción
Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Systolic blood pressure
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Descripción
Diastolic blood pressure
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Descripción
Position should be consistent throughout the study
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Descripción
Heart rate
Tipo de datos
text
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Descripción
Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Location should be consistent throughout the study
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C2826699
- UMLS CUI [1,2]
- C0039476
Descripción
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C0348016
Descripción
Investigational Product - Sequence Number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2]
- C2348184
Descripción
Investigational product code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0304229
Descripción
Investigational product - Start date and time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C3897500
- UMLS CUI [1,2]
- C0304229
Descripción
Investigational product - Stop date and time
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C3899266
- UMLS CUI [1,2]
- C0304229
Descripción
Was dose interrupted?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C1512900
Descripción
Primary reason for interruption
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C1512900
- UMLS CUI [2]
- C0392360
Descripción
Rate of Infusion
Tipo de datos
integer
Unidades de medida
- mL/h
Alias
- UMLS CUI [1]
- C2964135
Descripción
Rate of infusion unit
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2964135
- UMLS CUI [1,2]
- C1519795
Descripción
Total Volume of Infusion unit
Alias
- UMLS CUI-1
- C0574032
- UMLS CUI-2
- C2700258
- UMLS CUI-3
- C0439810
Descripción
Total volume of infusion administered
Tipo de datos
integer
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
- UMLS CUI [1,3]
- C0439810
Descripción
Was the total volume of infusion administered?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
- UMLS CUI [1,3]
- C0439810
Descripción
Primary reason for stoppage?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0574032
- UMLS CUI [2,1]
- C0392360
- UMLS CUI [2,2]
- C1947925
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Visit 2 - Biomarker Samples; Pharmacogenetic Research Consent; Transcriptomic Research Sample Collection Details; PK Blood Sample; Vital Signs; Investigational Product IV Dosing
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C0178913 (UMLS CUI [1,2])
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C0444930 (UMLS CUI [2,1])
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C0178913 (UMLS CUI [1,2])
C0444930 (UMLS CUI [2,1])
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C1299222 (UMLS CUI [3])
C0332307 (UMLS CUI-2)
C0805701 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0039476 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C0348016 (UMLS CUI-3)
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C1519795 (UMLS CUI [1,2])
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