Information:
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ID
40246
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 (2)
- 3/24/20 3/24/20 -
- 3/24/20 3/24/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 24, 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
Unscheduled - PK Blood Sample; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score
Similar models
Unscheduled - PK Blood Sample; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PK Blood Sample - Point in Time Collection
C0201734 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
C0178913 (UMLS CUI-2)
C1516698 (UMLS CUI-3)
Sample taken?
Item
Sample taken?
boolean
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
Sample taken - Actual date and time
Item
Sample taken - Actual date and time
datetime
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0178913 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
Sample taken - Sample Identifier/ Sample Number
Item
Sample taken - Sample Identifier/ Sample Number
text
C0201734 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
C0178913 (UMLS CUI [1,2])
C1299222 (UMLS CUI [2])
PK Type Code
Item
PK Type Code
text
C0031328 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item
Joint Pain/ Tenderness
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
CL Item
Temporomandibular left (1)
CL Item
Temporomandibular right (2)
CL Item
Sternoclavicular left (3)
CL Item
Sternoclavicular right (4)
CL Item
Acromioclavicular left (5)
CL Item
Acromioclaicular right (6)
CL Item
Shoulder left (7)
CL Item
Shoulder right (8)
CL Item
Elbow left (9)
CL Item
Elbow right (10)
CL Item
Wrist left (11)
CL Item
Wrist right (12)
CL Item
MCP 1 left (13)
CL Item
MCP 1 right (14)
CL Item
MCP 2 left (15)
CL Item
MCP 2 right (16)
CL Item
MCP 3 left (17)
CL Item
MCP 3 right (18)
CL Item
MCP 4 left (19)
CL Item
MCP 4 right (20)
CL Item
MCP 5 left (21)
CL Item
MCP 5 right (22)
CL Item
IP (thumb) left (23)
CL Item
IP (thumb) right (24)
CL Item
PIP 2 (finger) left (25)
CL Item
PIP 2 (finger) right (26)
CL Item
PIP 3 (finger) left (27)
CL Item
PIP 3 (finger) right (28)
CL Item
PIP 4 (finger) left (29)
CL Item
PIP 4 (finger) right (30)
CL Item
PIP 5 (finger) left (31)
CL Item
PIP 5 (finger) right (32)
Item
Joint Pain/Tenderness Finding
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Absent (0)
CL Item
Present (1)
CL Item
Non-Evaluable injection (3)
CL Item
Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
Item
Joint Pain/ Tenderness
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
C0003862 (UMLS CUI [1,2])
CL Item
DIP 1 left (33)
CL Item
DIP 1 right (34)
CL Item
DIP 2 left (35)
CL Item
DIP 2 right (36)
CL Item
DIP 3 left (37)
CL Item
DIP 3 right (38)
CL Item
DIP 4 left (39)
CL Item
DIP 4 right (40)
CL Item
HIP left (41)
CL Item
HIP right (42)
CL Item
Knee left (43)
CL Item
Knee right (44)
CL Item
Ankle Mortise left (45)
CL Item
Ankle Mortise right (46)
CL Item
Tarsi (midfoot) left (47)
CL Item
Tarsi (midfoot) right (48)
CL Item
MTP 1 left (49)
CL Item
MTP 1 right (50)
CL Item
MTP 2 left (51)
CL Item
MTP 2 right (52)
CL Item
MTP 3 left (53)
CL Item
MTP 3 right (54)
CL Item
MTP 4 left (55)
CL Item
MTP 4 right (56)
CL Item
MTP 5 left (57)
CL Item
MTP 5 right (58)
CL Item
IP (toe) left (59)
CL Item
IP (toe) right (60)
CL Item
PIP 2 (toe) left (61)
CL Item
PIP 2 (toe) right (62)
CL Item
PIP 3 (toe) left (63)
CL Item
PIP 3 (toe) right (64)
CL Item
PIP 4 (toe) left (65)
CL Item
PIP 4 (toe) right (66)
CL Item
PIP 5 (toe) left (67)
CL Item
PIP 5 (toe) right (68)
Item
Joint Pain/Tenderness Finding
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0003862 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
CL Item
Absent (0)
CL Item
Present (1)
CL Item
Non-Evaluable injection (3)
CL Item
Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
Item Group
Joint Assessor Initials - Joint Pain/Tenderness
C2986440 (UMLS CUI-1)
C0240094 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0240094 (UMLS CUI-4)
C0003862 (UMLS CUI-5)
C0240094 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0240094 (UMLS CUI-4)
C0003862 (UMLS CUI-5)
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
Item
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
text
C2986440 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0003862 (UMLS CUI [2,2])
C0220825 (UMLS CUI [1,2])
C0240094 (UMLS CUI [2,1])
C0003862 (UMLS CUI [2,2])
Item Group
Calculations - Joint Pain/Tenderness
C1441506 (UMLS CUI-1)
C0240094 (UMLS CUI-2)
C0003862 (UMLS CUI-3)
C0240094 (UMLS CUI-2)
C0003862 (UMLS CUI-3)
Tender/Painful joint count (based on 68 joint count)
Item
Tender/Painful joint count (based on 68 joint count)
integer
C0451530 (UMLS CUI [1])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
Total number of tender/painful joints assessed (based on 68 joint count)
Item
Total number of tender/painful joints assessed (based on 68 joint count)
integer
C0451530 (UMLS CUI [1,1])
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])
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])
Tender/Painful joint count subset (based on 28 joint count)
Item
Tender/Painful joint count subset (based on 28 joint count)
integer
C0451530 (UMLS CUI [1,1])
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])
C0003862 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
Total number of tender/painful joints assessed subset (based on 28 joint count)
Item
Total number of tender/painful joints assessed subset (based on 28 joint count)
integer
C0451530 (UMLS CUI [1,1])
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])
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])
CL Item
Temporomandibular left (1)
CL Item
Temporomandibular right (2)
CL Item
Sternoclavicular left (3)
CL Item
Sternoclavicular right (4)
CL Item
Acromioclavicular left (5)
CL Item
Acromioclaicular right (6)
CL Item
Shoulder left (7)
CL Item
Shoulder right (8)
CL Item
Elbow left (9)
CL Item
Elbow right (10)
CL Item
Wrist left (11)
CL Item
Wrist right (12)
CL Item
MCP 1 left (13)
CL Item
MCP 1 right (14)
CL Item
MCP 2 left (15)
CL Item
MCP 2 right (16)
CL Item
MCP 3 left (17)
CL Item
MCP 3 right (18)
CL Item
MCP 4 left (19)
CL Item
MCP 4 right (20)
CL Item
MCP 5 left (21)
CL Item
MCP 5 right (22)
CL Item
IP (thumb) left (23)
CL Item
IP (thumb) right (24)
CL Item
PIP 2 (finger) left (25)
CL Item
PIP 2 (finger) right (26)
CL Item
PIP 3 (finger) left (27)
CL Item
PIP 3 (finger) right (28)
CL Item
PIP 4 (finger) left (29)
CL Item
PIP 4 (finger) right (30)
CL Item
PIP 5 (finger) left (31)
CL Item
PIP 5 (finger) right (32)
Item
Joint Swelling Finding
integer
C0152031 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
Absent (0)
CL Item
Present (1)
CL Item
Non-Evaluable injection (3)
CL Item
Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
CL Item
DIP 1 left (33)
CL Item
DIP 1 right (34)
CL Item
DIP 2 left (35)
CL Item
DIP 2 right (36)
CL Item
DIP 3 left (37)
CL Item
DIP 3 right (38)
CL Item
DIP 4 left (39)
CL Item
DIP 4 right (40)
CL Item
HIP left (41)
CL Item
HIP right (42)
CL Item
Knee left (43)
CL Item
Knee right (44)
CL Item
Ankle Mortise left (45)
CL Item
Ankle Mortise right (46)
CL Item
Tarsi (midfoot) left (47)
CL Item
Tarsi (midfoot) right (48)
CL Item
MTP 1 left (49)
CL Item
MTP 1 right (50)
CL Item
MTP 2 left (51)
CL Item
MTP 2 right (52)
CL Item
MTP 3 left (53)
CL Item
MTP 3 right (54)
CL Item
MTP 4 left (55)
CL Item
MTP 4 right (56)
CL Item
MTP 5 left (57)
CL Item
MTP 5 right (58)
CL Item
IP (toe) left (59)
CL Item
IP (toe) right (60)
CL Item
PIP 2 (toe) left (61)
CL Item
PIP 2 (toe) right (62)
CL Item
PIP 3 (toe) left (63)
CL Item
PIP 3 (toe) right (64)
CL Item
PIP 4 (toe) left (65)
CL Item
PIP 4 (toe) right (66)
CL Item
PIP 5 (toe) left (67)
CL Item
PIP 5 (toe) right (68)
Item
Joint Swelling Finding
integer
C0152031 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
CL Item
Absent (0)
CL Item
Present (1)
CL Item
Non-Evaluable injection (3)
CL Item
Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
Item Group
Joint Assessor Initials - Joint Swelling
C2986440 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0152031 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C0152031 (UMLS CUI-3)
Initials of Independent joint assessor who performed evaluation - Joint Swelling
Item
Initials of Independent joint assessor who performed evaluation - Joint Swelling
text
C2986440 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0152031 (UMLS CUI [2])
C0220825 (UMLS CUI [1,2])
C0152031 (UMLS CUI [2])
Item Group
Calculations - Joint Swelling
C1441506 (UMLS CUI-1)
C0152031 (UMLS CUI-2)
C0152031 (UMLS CUI-2)
Swollen joint count (based on 66 joint count)
Item
Swollen joint count (based on 66 joint count)
integer
C0451521 (UMLS CUI [1])
Total number of swollen joints assessed (based on 66 joint count)
Item
Total number of swollen joints assessed (based on 66 joint count)
integer
C0451521 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Swollen joint count subset (based on 28 joint count)
Item
Swollen joint count subset (based on 28 joint count)
integer
C0451521 (UMLS CUI [1,1])
C1515021 (UMLS CUI [1,2])
C1515021 (UMLS CUI [1,2])
Total number of swollen joints assessed subset (based on 28 joint count)
Item
Total number of swollen joints assessed subset (based on 28 joint count)
integer
C0451521 (UMLS CUI [1,1])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
C1515021 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
Item Group
Swollen/ Tender Joint Count
C0451521 (UMLS CUI-1)
C0451530 (UMLS CUI-2)
C0451530 (UMLS CUI-2)
Does the patient have > 8 swollen joints and > 8 tender joints?'
Item
Does the patient have > 8 swollen joints and > 8 tender joints?'
boolean
C0451521 (UMLS CUI [1,1])
C0451530 (UMLS CUI [1,2])
C0451530 (UMLS CUI [1,2])
Item Group
Pain Assessment VAS Score
C1161170 (UMLS CUI-1)
C0042815 (UMLS CUI-2)
C0042815 (UMLS CUI-2)
Pain Assessment VAS Score - Assessment Date
Item
Pain Assessment VAS Score - Assessment Date
date
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C1161170 (UMLS CUI [2,1])
C0042815 (UMLS CUI [2,2])
C2985720 (UMLS CUI [2,3])
C0042815 (UMLS CUI [1,2])
C1161170 (UMLS CUI [2,1])
C0042815 (UMLS CUI [2,2])
C2985720 (UMLS CUI [2,3])
Pain Assessment VAS Score
Item
Pain Assessment VAS Score
integer
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C0042815 (UMLS CUI [1,2])
Item
Pain Assessment VAS Score - ISO Language code
text
C1161170 (UMLS CUI [1,1])
C0042815 (UMLS CUI [1,2])
C1708640 (UMLS CUI [2])
C0042815 (UMLS CUI [1,2])
C1708640 (UMLS CUI [2])
Code List
Pain Assessment VAS Score - ISO Language code
CL Item
Danish (DAN)
CL Item
English (ENG)
CL Item
Finnish (FIN)
CL Item
French (FRE)
CL Item
German (GER)
CL Item
Italian (ITA)
CL Item
Korean (KOR)
CL Item
Norwegian (NOR)
CL Item
Spanish (SPA)
CL Item
Swedish (SWE)
CL Item
Dutch (DUT)
CL Item
Portuguese (POR)
Item Group
Patient's Global Assessment of Arthritis Condition VAS Score
C0281858 (UMLS CUI-1)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
Arthritis Condition VAS Score - Assessment Date
Item
Arthritis Condition VAS Score - Assessment Date
date
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C2985720 (UMLS CUI [2])
VAS Score
Item
VAS Score
integer
C2960751 (UMLS CUI [1])
Item
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
text
C0281858 (UMLS CUI [1,1])
C0003864 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
C0003864 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0449820 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
Code List
Patient's Global Assessment of Arthritis Condition VAS Score - ISO Language code
CL Item
Danish (DAN)
CL Item
English (ENG)
CL Item
Finnish (FIN)
CL Item
French (FRE)
CL Item
German (GER)
CL Item
Italian (ITA)
CL Item
Korean (KOR)
CL Item
Norwegian (NOR)
CL Item
Spanish (SPA)
CL Item
Swedish (SWE)
CL Item
Dutch; Flemish (DUT)
CL Item
Portuguese (POR)
CL Item
Afrikaans (AFR)
CL Item
Czech (CES)
CL Item
Chinese (CHI)
CL Item
Hungarian (HUN)
CL Item
Lithuanian (LIT)
CL Item
Polish (POL)
CL Item
Romanian (RUM)
CL Item
Russian (RUS)
Item Group
Physician's Global Assessment of Arthritis Condition VAS Score
C0281858 (UMLS CUI-1)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
C0003864 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0449820 (UMLS CUI-4)
C0031831 (UMLS CUI-5)
Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
Item
Physician's Global Assessment of Arthritis Condition VAS Score - Assessment Date
date
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C2985720 (UMLS CUI [2])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C2985720 (UMLS CUI [2])
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
Item
Physician's Global Assessment of Arthritis Condition VAS Score -VAS Score
integer
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
Item
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
text
C0003864 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
C0449438 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,4])
C1708640 (UMLS CUI [2])
Code List
Physician's Global Assessment of Arthritis Condition VAS Score - ISO Language code
CL Item
Danish (DAN)
CL Item
English (ENG)
CL Item
Finnish (FIN)
CL Item
French (FRE)
CL Item
German (GER)
CL Item
Italian (ITA)
CL Item
Korean (KOR)
CL Item
Norwegian (NOR)
CL Item
Spanish (SPA)
CL Item
Swedish (SWE)
CL Item
Dutch (DUT)
CL Item
Portuguese (POR)