ID

40229

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

  1. 3/23/20 3/23/20 -
  2. 3/23/20 3/23/20 -
  3. 3/23/20 3/23/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 23, 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

Visit 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count

Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood pressure systolic
Description

Blood pressure systolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject position
Description

Position should be consistent throughout the study

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Location of temperature
Description

Location should be consistent throughout the study

Data type

integer

Alias
UMLS CUI [1,1]
C2826699
UMLS CUI [1,2]
C0039476
Neurological Examination
Description

Neurological Examination

Alias
UMLS CUI-1
C0027853
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Description

If Yes record details on the Non Serious Adverse Event or Serious Adverse Events forms as appropriate.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C2349155
UMLS CUI [1,3]
C0037088
UMLS CUI [1,4]
C0023524
Tender Joint Count Page 1
Description

Tender Joint Count Page 1

Alias
UMLS CUI-1
C0451530
Joint Pain/ Tenderness
Description

Joint Pain/ Tenderness

Data type

integer

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C0003862
Joint Pain/Tenderness Finding
Description

Joint Pain/Tenderness Finding

Data type

integer

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C0003862
UMLS CUI [1,3]
C0243095
Tender Joint Count Page 2
Description

Tender Joint Count Page 2

Alias
UMLS CUI-1
C0451530
Joint Pain/ Tenderness
Description

Joint Pain/ Tenderness

Data type

integer

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C0003862
Joint Pain/Tenderness Finding
Description

Joint Pain/Tenderness Finding

Data type

integer

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C0003862
UMLS CUI [1,3]
C0243095
Joint Assessor Initials - Joint Pain/Tenderness
Description

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
Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
Description

Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0220825
UMLS CUI [2,1]
C0240094
UMLS CUI [2,2]
C0003862
Calculations - Joint Pain/Tenderness
Description

Calculations - Joint Pain/Tenderness

Alias
UMLS CUI-1
C1441506
UMLS CUI-2
C0240094
UMLS CUI-3
C0003862
Tender/Painful joint count (based on 68 joint count)
Description

Tender/Painful joint count (based on 68 joint count)

Data type

integer

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2,1]
C0003862
UMLS CUI [2,2]
C0750480
Total number of tender/painful joints assessed (based on 68 joint count)
Description

Total number of tender/painful joints assessed (based on 68 joint count)

Data type

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
Tender/Painful joint count subset (based on 28 joint count)
Description

Tender/Painful joint count subset (based on 28 joint count)

Data type

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
Total number of tender/painful joints assessed subset (based on 28 joint count)
Description

Total number of tender/painful joints assessed subset (based on 28 joint count)

Data type

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
Swollen Joint Count Page 1
Description

Swollen Joint Count Page 1

Alias
UMLS CUI-1
C0451521
Joint Swelling
Description

Joint Swelling

Data type

text

Alias
UMLS CUI [1]
C0152031
Joint Swelling Finding
Description

Joint Swelling Finding

Data type

integer

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C0243095
Swollen Joint Count Page 2
Description

Swollen Joint Count Page 2

Alias
UMLS CUI-1
C0451521
Joint Swelling
Description

Joint Swelling

Data type

integer

Alias
UMLS CUI [1]
C0152031
Joint Swelling Finding
Description

Joint Swelling Finding

Data type

integer

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C0243095
Joint Assessor Initials - Joint Swelling
Description

Joint Assessor Initials - Joint Swelling

Alias
UMLS CUI-1
C2986440
UMLS CUI-2
C0220825
UMLS CUI-3
C0152031
Initials of Independent joint assessor who performed evaluation - Joint Swelling
Description

Initials of Independent joint assessor who performed evaluation - Joint Swelling

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0220825
UMLS CUI [2]
C0152031
Calculations - Joint Swelling
Description

Calculations - Joint Swelling

Alias
UMLS CUI-1
C1441506
UMLS CUI-2
C0152031
Swollen joint count (based on 66 joint count)
Description

Swollen joint count (based on 66 joint count)

Data type

integer

Alias
UMLS CUI [1]
C0451521
Total number of swollen joints assessed (based on 66 joint count)
Description

Total number of swollen joints assessed (based on 66 joint count)

Data type

integer

Alias
UMLS CUI [1,1]
C0451521
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0220825
Swollen joint count subset (based on 28 joint count)
Description

Swollen joint count subset (based on 28 joint count)

Data type

integer

Alias
UMLS CUI [1,1]
C0451521
UMLS CUI [1,2]
C1515021
Total number of swollen joints assessed subset (based on 28 joint count)
Description

Total number of swollen joints assessed subset (based on 28 joint count)

Data type

integer

Alias
UMLS CUI [1,1]
C0451521
UMLS CUI [1,2]
C1515021
UMLS CUI [1,3]
C0237753
UMLS CUI [1,4]
C0220825
Swollen/ Tender Joint Count
Description

Swollen/ Tender Joint Count

Alias
UMLS CUI-1
C0451521
UMLS CUI-2
C0451530
Does the patient have > 8 swollen joints and > 8 tender joints?'
Description

If the response is NO, patient is not eligible to continue in the study. Complete the Run-In Failure form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0451521
UMLS CUI [1,2]
C0451530

Similar models

Visit 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Code List
Subject position
CL Item
Supine  (1)
CL Item
Sitting  (2)
CL Item
Standing  (3)
CL Item
Semi-supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Location of temperature
integer
C2826699 (UMLS CUI [1,1])
C0039476 (UMLS CUI [1,2])
Code List
Location of temperature
CL Item
Oral (1)
CL Item
Rectal  (2)
CL Item
Axilla  (3)
CL Item
Tympanic  (4)
CL Item
Intra-arterial (5)
Item Group
Neurological Examination
C0027853 (UMLS CUI-1)
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
Item
From the neurological examination worksheet, are there any signs/symptoms indicative of PML?
boolean
C0027853 (UMLS CUI [1,1])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
Item Group
Tender Joint Count Page 1
C0451530 (UMLS CUI-1)
Item
Joint Pain/ Tenderness
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
Code List
Joint Pain/ Tenderness
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])
Code List
Joint Pain/Tenderness Finding
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
Tender Joint Count Page 2
C0451530 (UMLS CUI-1)
Item
Joint Pain/ Tenderness
integer
C0240094 (UMLS CUI [1,1])
C0003862 (UMLS CUI [1,2])
Code List
Joint Pain/ Tenderness
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])
Code List
Joint Pain/Tenderness Finding
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)
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])
Item Group
Calculations - Joint Pain/Tenderness
C1441506 (UMLS CUI-1)
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])
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])
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])
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])
Item Group
Swollen Joint Count Page 1
C0451521 (UMLS CUI-1)
Item
Joint Swelling
text
C0152031 (UMLS CUI [1])
Code List
Joint Swelling
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])
Code List
Joint Swelling Finding
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
Swollen Joint Count Page 2
C0451521 (UMLS CUI-1)
Item
Joint Swelling
integer
C0152031 (UMLS CUI [1])
Code List
Joint Swelling
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])
Code List
Joint Swelling Finding
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)
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])
Item Group
Calculations - Joint Swelling
C1441506 (UMLS CUI-1)
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])
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])
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])
Item Group
Swollen/ Tender Joint Count
C0451521 (UMLS CUI-1)
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])

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