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ID
40229
Descrição
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
Palavras-chave
Versões (3)
- 23/03/2020 23/03/2020 -
- 23/03/2020 23/03/2020 -
- 23/03/2020 23/03/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
23 de março de 2020
DOI
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Licença
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
Similar models
Visit 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
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])
C0039476 (UMLS CUI [1,2])
CL Item
Oral (1)
CL Item
Rectal (2)
CL Item
Axilla (3)
CL Item
Tympanic (4)
CL Item
Intra-arterial (5)
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])
C2349155 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0023524 (UMLS CUI [1,4])
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])