ID
40229
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 (3)
- 23-03-20 23-03-20 -
- 23-03-20 23-03-20 -
- 23-03-20 23-03-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 maart 2020
DOI
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Licentie
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 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count
Beschrijving
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C2349155
- UMLS CUI [1,3]
- C0037088
- UMLS CUI [1,4]
- C0023524
Beschrijving
Tender Joint Count Page 1
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
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
Similar models
Visit 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count
C0039476 (UMLS CUI [1,2])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
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])