ID

40248

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. 3/24/20 3/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 24, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

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
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Haematology Date sample taken
Description

Haematology Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1302413
Haematology sample taken - Not Done
Description

Haematology sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1272696
Biochemistry Date sample taken
Description

Biochemistry Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1302413
Biochemistry sample taken - Not Done
Description

Biochemistry sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0005477
UMLS CUI [1,3]
C1272696
Urinalysis Date sample taken
Description

Urinalysis Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0042014
Urinalysis sample taken - Not Done
Description

Urinalysis sample taken - Not Done

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1272696
Haem Lab type code
Description

Haem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0022877
Chem Lab type code
Description

Chem Lab type code

Data type

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Urin Lab type code
Description

Urin Lab type code

Data type

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

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Haematology Date sample taken
Item
Haematology Date sample taken
date
C0018941 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Haematology sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Haematology sample taken - Not Done
CL Item
Not Done (ND)
Biochemistry Date sample taken
Item
Biochemistry Date sample taken
date
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Biochemistry sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Biochemistry sample taken - Not Done
CL Item
Not Done (ND)
Urinalysis Date sample taken
Item
Urinalysis Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
Item
Urinalysis sample taken - Not Done
text
C0005834 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Urinalysis sample taken - Not Done
CL Item
Not Done (ND)
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial