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