ID
40248
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
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 - Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Electronically Transferred Lab Data
Beschrijving
Tender Joint Count Page 2
Alias
- UMLS CUI-1
- C0451530
Beschrijving
Joint Pain/ Tenderness
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
Beschrijving
Joint Pain/Tenderness Finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0240094
- UMLS CUI [1,2]
- C0003862
- UMLS CUI [1,3]
- C0243095
Beschrijving
Joint Assessor Initials - Joint Pain/Tenderness
Alias
- UMLS CUI-1
- C2986440
- UMLS CUI-2
- C0240094
- UMLS CUI-3
- C0220825
- UMLS CUI-4
- C0240094
- UMLS CUI-5
- C0003862
Beschrijving
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2,1]
- C0240094
- UMLS CUI [2,2]
- C0003862
Beschrijving
Calculations - Joint Pain/Tenderness
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0240094
- UMLS CUI-3
- C0003862
Beschrijving
Tender/Painful joint count (based on 68 joint count)
Datatype
integer
Alias
- UMLS CUI [1]
- C0451530
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
Beschrijving
Total number of tender/painful joints assessed (based on 68 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0220825
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C0237753
- UMLS CUI [2,4]
- C0220825
Beschrijving
Tender/Painful joint count subset (based on 28 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C1515021
Beschrijving
Total number of tender/painful joints assessed subset (based on 28 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451530
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C0220825
- UMLS CUI [2,1]
- C0003862
- UMLS CUI [2,2]
- C0750480
- UMLS CUI [2,3]
- C1515021
- UMLS CUI [2,4]
- C0237753
- UMLS CUI [2,5]
- C0220825
Beschrijving
Swollen Joint Count Page 1
Alias
- UMLS CUI-1
- C0451521
Beschrijving
Joint Swelling
Datatype
text
Alias
- UMLS CUI [1]
- C0152031
Beschrijving
Joint Swelling Finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beschrijving
Swollen Joint Count Page 2
Alias
- UMLS CUI-1
- C0451521
Beschrijving
Joint Swelling
Datatype
integer
Alias
- UMLS CUI [1]
- C0152031
Beschrijving
Joint Swelling Finding
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0152031
- UMLS CUI [1,2]
- C0243095
Beschrijving
Joint Assessor Initials - Joint Swelling
Alias
- UMLS CUI-1
- C2986440
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0152031
Beschrijving
Calculations - Joint Swelling
Alias
- UMLS CUI-1
- C1441506
- UMLS CUI-2
- C0152031
Beschrijving
Swollen joint count (based on 66 joint count)
Datatype
integer
Alias
- UMLS CUI [1]
- C0451521
Beschrijving
Total number of swollen joints assessed (based on 66 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C0220825
Beschrijving
Swollen joint count subset (based on 28 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
Beschrijving
Total number of swollen joints assessed subset (based on 28 joint count)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451521
- UMLS CUI [1,2]
- C1515021
- UMLS CUI [1,3]
- C0237753
- UMLS CUI [1,4]
- C0220825
Beschrijving
Swollen/ Tender Joint Count
Alias
- UMLS CUI-1
- C0451521
- UMLS CUI-2
- C0451530
Beschrijving
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- C1705822
Beschrijving
Haematology Date sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1302413
Beschrijving
Haematology sample taken - Not Done
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0018941
- UMLS CUI [1,3]
- C1272696
Beschrijving
Biochemistry Date sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005477
- UMLS CUI [1,2]
- C1302413
Beschrijving
Biochemistry sample taken - Not Done
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0005477
- UMLS CUI [1,3]
- C1272696
Beschrijving
Urinalysis Date sample taken
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0042014
Beschrijving
Urinalysis sample taken - Not Done
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0042014
- UMLS CUI [1,3]
- C1272696
Beschrijving
Haem Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
Beschrijving
Chem Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beschrijving
Urin Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Similar models
Early Withdrawal - Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Electronically Transferred Lab Data
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0240094 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0240094 (UMLS CUI-4)
C0003862 (UMLS CUI-5)
C0220825 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0003862 (UMLS CUI [2,2])
C0240094 (UMLS CUI-2)
C0003862 (UMLS CUI-3)
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0220825 (UMLS CUI [2,4])
C1515021 (UMLS CUI [1,2])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
C0237753 (UMLS CUI [2,4])
C0220825 (UMLS CUI [2,5])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0152031 (UMLS CUI-3)
C0220825 (UMLS CUI [1,2])
C0152031 (UMLS CUI [2])
C0152031 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C1515021 (UMLS CUI [1,2])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C0451530 (UMLS CUI-2)
C0451530 (UMLS CUI [1,2])
C1705822 (UMLS CUI-2)
C1302413 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])