ID
40308
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)
- 4/2/20 4/2/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 2, 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
Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)
Description
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
Liver Events - Date of assessment
Data type
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2985720
Description
Check all that apply
Data type
text
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
Description
Is the subject age 55 or older?
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
If yes, ensure Pregnancy Notification Form has been completed.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
Were any diagnostic imaging tests of the liver or hepatobiliary system performed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [2]
- C1456803
- UMLS CUI [3]
- C0040405
- UMLS CUI [4]
- C0436427
- UMLS CUI [5]
- C0024485
- UMLS CUI [6]
- C0008310
Description
If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C1711359
- UMLS CUI [1,3]
- C0023884
- UMLS CUI [2,1]
- C1274040
- UMLS CUI [2,2]
- C0011923
Description
If yes, complete Liver Biopsy form.
Data type
boolean
Alias
- UMLS CUI [1]
- C0193388
Description
If yes, record on the appropriate Concomitant Medication form.
Data type
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0281875
Description
Did the subject fast or undergo significant dietary change in the past week?
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C3671772
Description
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Description
Start Date Investigational Product - During treatment period
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Description
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Description
Stop Date Investigational Product - During treatment period
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0347984
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Description
Start Date Investigational Product - After treatment period
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Description
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Description
Stop Date Investigational Product - After treatment period
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0087111
- UMLS CUI [2,2]
- C1948053
- UMLS CUI [2,3]
- C0687676
Description
Pharmacokinetics (Liver)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Description
Was a pharmacokinetic blood sample obtained?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
Date and time of last investigational product dose prior to PK sample
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
- UMLS CUI [3,1]
- C1277698
- UMLS CUI [3,2]
- C0031327
- UMLS CUI [3,3]
- C0332152
Description
Sample Identifier/Sample Number
Data type
text
Alias
- UMLS CUI [1]
- C1299222
Description
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Description
Does the subject consume alcohol?
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
Record the average number of units of alcohol consumed per week
Data type
float
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Description
Substance Use Type
Data type
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Description
Medical Conditions (Liver)
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0023884
Description
Medical Condition
Data type
integer
Alias
- UMLS CUI [1]
- C0012634
Description
Condition Status
Data type
integer
Alias
- UMLS CUI [1]
- C3176928
Description
Drug related liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0277579
Description
Other Liver disease conditions
Alias
- UMLS CUI-1
- C0023895
- UMLS CUI-2
- C0205394
Description
Other Liver disease conditions - Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348184
Description
Other Liver disease conditions - Specific Condition
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Other Liver disease conditions - Modified Term
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826302
Description
Other Liver disease conditions - MedDRA Synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1140263
Description
Other Liver disease conditions - MedDRA lower level term code
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3898442
Description
Other Liver disease conditions - Failed coding
Data type
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0805701
- UMLS CUI [1,4]
- C0231175
Description
Other Liver disease conditions - Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0449438
Description
Other medical conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0205394
Description
Other medical condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0205394
Description
Other medical condition
Data type
integer
Alias
- UMLS CUI [1,1]
- C3176928
- UMLS CUI [1,2]
- C0205394
Similar models
Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)
C0574032 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0039476 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
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])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0436427 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
C3671772 (UMLS CUI [2])
C0023884 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C0023884 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C1277698 (UMLS CUI [3,1])
C0031327 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C0560579 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1140263 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C3898442 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])