ID
40254
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)
- 25-03-20 25-03-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 maart 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455
Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation
Beschrijving
PK Blood Sample - Point in Time Collection
Alias
- UMLS CUI-1
- C0201734
- UMLS CUI-2
- C0178913
- UMLS CUI-3
- C1516698
Beschrijving
Sample taken before infusion?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
Beschrijving
Sample taken - Actual date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2]
- C1264639
Beschrijving
Sample taken - Sample Identifier/ Sample Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201734
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [2]
- C1299222
Beschrijving
PK Type Code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0805701
Beschrijving
Biomarker Samples
Alias
- UMLS CUI-1
- C0005516
- UMLS CUI-2
- C0370003
Beschrijving
Has sample been collected?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Date sample taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
If sample has not been collected, provide reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C2826287
Beschrijving
If other reason for sample has not been collected, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C2826287
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C2348235
Beschrijving
Sample Type
Datatype
text
Alias
- UMLS CUI [1]
- C2347029
Beschrijving
Sample Number
Datatype
text
Alias
- UMLS CUI [1]
- C1299222
Beschrijving
Transcriptomic Research Sample Collection Details
Alias
- UMLS CUI-1
- C3178810
- UMLS CUI-2
- C0035168
- UMLS CUI-3
- C0005834
- UMLS CUI-4
- C1522508
Beschrijving
Has a blood sample been collected for transcriptomic research?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3178810
- UMLS CUI [1,2]
- C0035168
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C1522508
Beschrijving
Transcriptomic Research - Date and time sample taken
Datatype
date
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
Beschrijving
PGm-T Type
Datatype
text
Alias
- UMLS CUI [1]
- C1831759
Beschrijving
Transcriptomic Research - Sample Type
Datatype
text
Alias
- UMLS CUI [1,1]
- C3178810
- UMLS CUI [1,2]
- C0035168
- UMLS CUI [2]
- C2347029
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?
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
Beschrijving
Investigational Product Discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Beschrijving
If yes, complete primary reason
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
- UMLS CUI [2,1]
- C0574032
- UMLS CUI [2,2]
- C0016884
- UMLS CUI [3]
- C0304229
Beschrijving
Date of early investigational product withdrawal
Datatype
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0011008
Beschrijving
Select primary reason the investigational product was stopped
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0457454
Beschrijving
Specify investigator discretion
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Beschrijving
Specify withdrew consent
Datatype
text
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C2348235
Similar models
Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation
C0011008 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0035168 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C1522508 (UMLS CUI-4)
C0035168 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C1522508 (UMLS CUI [2,2])
C0035168 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
C0035168 (UMLS CUI [1,2])
C2347029 (UMLS CUI [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])
C0457454 (UMLS CUI-2)
C0574032 (UMLS CUI [2,1])
C0016884 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C0013227 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])