Trial Outcomes & Findings for Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs (NCT NCT01083693)
NCT ID: NCT01083693
Last Updated: 2011-08-11
Results Overview
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).
Recruitment status
COMPLETED
Target enrollment
162 participants
Primary outcome timeframe
Baseline, months 3,6,9,12
Results posted on
2011-08-11
Participant Flow
A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.
Participant milestones
| Measure |
Rheumatoid Arthritis (RA)
Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Ankylosing Spondylitis (AS)
Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
28
|
40
|
|
Overall Study
COMPLETED
|
73
|
22
|
33
|
|
Overall Study
NOT COMPLETED
|
20
|
6
|
7
|
Reasons for withdrawal
| Measure |
Rheumatoid Arthritis (RA)
Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Ankylosing Spondylitis (AS)
Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
|
Overall Study
Lack of effectiveness
|
13
|
2
|
2
|
|
Overall Study
Patient Moved
|
0
|
1
|
0
|
|
Overall Study
Complete remission
|
0
|
1
|
0
|
|
Overall Study
Other medical condition/surgery
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
2
|
|
Overall Study
Reason unknown
|
0
|
0
|
1
|
Baseline Characteristics
Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Ankylosing Spondylitis (AS)
n=40 Participants
Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
55.7 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
42.0 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
93 participants
n=5 Participants
|
28 participants
n=7 Participants
|
40 participants
n=5 Participants
|
161 participants
n=4 Participants
|
|
Duration of underlying disease
|
7.6 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
6.2 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
8.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
7.7 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=121 Participants
|
Total
|
|---|---|---|---|---|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
Baseline
|
1.2 Units on a scale
Standard Deviation 0.7
|
0.9 Units on a scale
Standard Deviation 0.7
|
1.1 Units on a scale
Standard Deviation 0.7
|
—
|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
3 months
|
0.9 Units on a scale
Standard Deviation 0.7
|
0.4 Units on a scale
Standard Deviation 0.4
|
0.8 Units on a scale
Standard Deviation 0.7
|
—
|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
6 months
|
0.8 Units on a scale
Standard Deviation 0.6
|
0.4 Units on a scale
Standard Deviation 0.5
|
0.7 Units on a scale
Standard Deviation 0.6
|
—
|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
9 months
|
0.8 Units on a scale
Standard Deviation 0.6
|
0.3 Units on a scale
Standard Deviation 0.5
|
0.7 Units on a scale
Standard Deviation 0.6
|
—
|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
12 months
|
0.7 Units on a scale
Standard Deviation 0.6
|
0.2 Units on a scale
Standard Deviation 0.3
|
0.6 Units on a scale
Standard Deviation 0.6
|
—
|
|
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
Early Termination
|
1.4 Units on a scale
Standard Deviation 0.9
|
0.0 Units on a scale
Standard Deviation 0.0
|
1.2 Units on a scale
Standard Deviation 1.0
|
—
|
PRIMARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[participants who discontinued the study early\]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.
Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=40 Participants
|
Total
n=161 Participants
|
|---|---|---|---|---|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - 6 months
|
78.4 Units on a scale
Standard Deviation 20.5
|
85.7 Units on a scale
Standard Deviation 19.1
|
81.0 Units on a scale
Standard Deviation 23.0
|
80.4 Units on a scale
Standard Deviation 21.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - Early Termination
|
39.0 Units on a scale
Standard Deviation 26.2
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
39.0 Units on a scale
Standard Deviation 26.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - Baseline
|
39.3 Units on a scale
Standard Deviation 19.0
|
39.8 Units on a scale
Standard Deviation 21.1
|
32.4 Units on a scale
Standard Deviation 18.7
|
37.7 Units on a scale
Standard Deviation 19.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - 3 months
|
53.6 Units on a scale
Standard Deviation 19.3
|
53.3 Units on a scale
Standard Deviation 19.7
|
54.5 Units on a scale
Standard Deviation 20.4
|
53.8 Units on a scale
Standard Deviation 19.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - 6 months
|
52.6 Units on a scale
Standard Deviation 16.0
|
56.8 Units on a scale
Standard Deviation 19.4
|
57.9 Units on a scale
Standard Deviation 19.4
|
54.7 Units on a scale
Standard Deviation 17.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - 9 months
|
52.3 Units on a scale
Standard Deviation 19.1
|
56.3 Units on a scale
Standard Deviation 16.0
|
59.2 Units on a scale
Standard Deviation 20.1
|
54.9 Units on a scale
Standard Deviation 19.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - 12 months
|
56.9 Units on a scale
Standard Deviation 17.7
|
65.0 Units on a scale
Standard Deviation 14.9
|
58.0 Units on a scale
Standard Deviation 21.5
|
58.7 Units on a scale
Standard Deviation 18.4
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Vitality - Early Termination
|
23.3 Units on a scale
Standard Deviation 16.3
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
23.3 Units on a scale
Standard Deviation 16.3
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - Baseline
|
59.5 Units on a scale
Standard Deviation 30.0
|
66.2 Units on a scale
Standard Deviation 31.2
|
52.8 Units on a scale
Standard Deviation 25.0
|
59.1 Units on a scale
Standard Deviation 29.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning -Baseline
|
51.4 Units on a scale
Standard Deviation 26.4
|
58.1 Units on a scale
Standard Deviation 26.2
|
53.3 Units on a scale
Standard Deviation 23.4
|
53.1 Units on a scale
Standard Deviation 25.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning - 3 months
|
67.4 Units on a scale
Standard Deviation 24.3
|
74.3 Units on a scale
Standard Deviation 21.3
|
76.5 Units on a scale
Standard Deviation 21.9
|
71.0 Units on a scale
Standard Deviation 23.4
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning - 6 months
|
65.3 Units on a scale
Standard Deviation 24.4
|
76.0 Units on a scale
Standard Deviation 21.9
|
79.4 Units on a scale
Standard Deviation 22.2
|
70.9 Units on a scale
Standard Deviation 24.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - 3 months
|
75.3 Units on a scale
Standard Deviation 20.9
|
79.3 Units on a scale
Standard Deviation 18.7
|
78.0 Units on a scale
Standard Deviation 21.4
|
76.8 Units on a scale
Standard Deviation 20.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - 9 months
|
79.0 Units on a scale
Standard Deviation 19.7
|
86.9 Units on a scale
Standard Deviation 20.1
|
83.2 Units on a scale
Standard Deviation 23.2
|
81.5 Units on a scale
Standard Deviation 20.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - 12 months
|
82.3 Units on a scale
Standard Deviation 20.4
|
93.1 Units on a scale
Standard Deviation 14.3
|
80.4 Units on a scale
Standard Deviation 25.1
|
83.8 Units on a scale
Standard Deviation 21.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Social Functioning - Early Termination
|
47.9 Units on a scale
Standard Deviation 31.0
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
47.9 Units on a scale
Standard Deviation 31.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Emotional - Baseline
|
45.1 Units on a scale
Standard Deviation 44.7
|
55.6 Units on a scale
Standard Deviation 43.4
|
40.7 Units on a scale
Standard Deviation 42.2
|
46.0 Units on a scale
Standard Deviation 43.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Emotional - 3 months
|
66.2 Units on a scale
Standard Deviation 42.3
|
75.4 Units on a scale
Standard Deviation 41.7
|
74.0 Units on a scale
Standard Deviation 35.7
|
69.8 Units on a scale
Standard Deviation 40.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Emotional - 6 months
|
69.7 Units on a scale
Standard Deviation 41.2
|
82.5 Units on a scale
Standard Deviation 35.9
|
76.3 Units on a scale
Standard Deviation 36.7
|
73.7 Units on a scale
Standard Deviation 39.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Emotional - 9 months
|
72.4 Units on a scale
Standard Deviation 40.5
|
78.3 Units on a scale
Standard Deviation 39.4
|
81.6 Units on a scale
Standard Deviation 31.6
|
76.0 Units on a scale
Standard Deviation 38.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Emotional - 12 months
|
78.2 Units on a scale
Standard Deviation 37.0
|
91.7 Units on a scale
Standard Deviation 26.2
|
75.0 Units on a scale
Standard Deviation 38.1
|
79.9 Units on a scale
Standard Deviation 35.7
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Emotional - Early Termination
|
33.3 Units on a scale
Standard Deviation 51.6
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
33.3 Units on a scale
Standard Deviation 51.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - Baseline
|
55.6 Units on a scale
Standard Deviation 21.5
|
63.1 Units on a scale
Standard Deviation 22.1
|
53.9 Units on a scale
Standard Deviation 21.0
|
56.6 Units on a scale
Standard Deviation 21.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - 3 months
|
66.1 Units on a scale
Standard Deviation 18.8
|
70.1 Units on a scale
Standard Deviation 19.0
|
70.4 Units on a scale
Standard Deviation 18.9
|
67.9 Units on a scale
Standard Deviation 18.9
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - 6 months
|
67.9 Units on a scale
Standard Deviation 16.3
|
75.8 Units on a scale
Standard Deviation 16.6
|
73.6 Units on a scale
Standard Deviation 18.9
|
70.8 Units on a scale
Standard Deviation 17.3
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - 9 months
|
70.7 Units on a scale
Standard Deviation 17.5
|
74.6 Units on a scale
Standard Deviation 21.1
|
76.1 Units on a scale
Standard Deviation 18.8
|
72.9 Units on a scale
Standard Deviation 18.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - 12 months
|
73.2 Units on a scale
Standard Deviation 14.8
|
81.8 Units on a scale
Standard Deviation 13.9
|
76.7 Units on a scale
Standard Deviation 17.2
|
75.8 Units on a scale
Standard Deviation 15.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Mental Health - Early Termination
|
41.3 Units on a scale
Standard Deviation 23.8
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
41.3 Units on a scale
Standard Deviation 23.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - Baseline
|
3.5 Units on a scale
Standard Deviation 1.2
|
3.5 Units on a scale
Standard Deviation 1.1
|
3.9 Units on a scale
Standard Deviation 1.1
|
3.6 Units on a scale
Standard Deviation 1.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - 3 months
|
2.0 Units on a scale
Standard Deviation 1.1
|
2.1 Units on a scale
Standard Deviation 1.1
|
1.8 Units on a scale
Standard Deviation 1.1
|
2.0 Units on a scale
Standard Deviation 1.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - 6 months
|
2.1 Units on a scale
Standard Deviation 1.0
|
1.8 Units on a scale
Standard Deviation 1.0
|
1.5 Units on a scale
Standard Deviation 0.8
|
1.9 Units on a scale
Standard Deviation 1.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - 9 months
|
1.9 Units on a scale
Standard Deviation 0.8
|
1.8 Units on a scale
Standard Deviation 1.0
|
1.4 Units on a scale
Standard Deviation 0.6
|
1.7 Units on a scale
Standard Deviation 0.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - 12 months
|
1.7 Units on a scale
Standard Deviation 0.9
|
1.4 Units on a scale
Standard Deviation 0.6
|
1.7 Units on a scale
Standard Deviation 0.9
|
1.6 Units on a scale
Standard Deviation 0.9
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Reported Health Transition - Early Termination
|
3.5 Units on a scale
Standard Deviation 2.0
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
3.5 Units on a scale
Standard Deviation 2.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning - 9 months
|
67.4 Units on a scale
Standard Deviation 24.6
|
79.8 Units on a scale
Standard Deviation 19.5
|
81.4 Units on a scale
Standard Deviation 18.7
|
73.4 Units on a scale
Standard Deviation 23.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning -12 months
|
70.3 Units on a scale
Standard Deviation 23.8
|
85.9 Units on a scale
Standard Deviation 13.2
|
80.4 Units on a scale
Standard Deviation 24.5
|
75.9 Units on a scale
Standard Deviation 23.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Physical Functioning - Early Termination
|
33.3 Units on a scale
Standard Deviation 28.6
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
33.3 Units on a scale
Standard Deviation 28.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning -Physical - Baseline
|
29.8 Units on a scale
Standard Deviation 40.5
|
38.9 Units on a scale
Standard Deviation 43.5
|
25.0 Units on a scale
Standard Deviation 32.2
|
30.3 Units on a scale
Standard Deviation 39.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Physical - 3 months
|
57.3 Units on a scale
Standard Deviation 43.5
|
58.7 Units on a scale
Standard Deviation 41.0
|
67.4 Units on a scale
Standard Deviation 38.8
|
60.2 Units on a scale
Standard Deviation 41.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Physical - 6 months
|
55.3 Units on a scale
Standard Deviation 44.0
|
70.2 Units on a scale
Standard Deviation 36.8
|
73.4 Units on a scale
Standard Deviation 37.6
|
62.7 Units on a scale
Standard Deviation 41.7
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Physical - 9 months
|
55.4 Units on a scale
Standard Deviation 43.7
|
72.5 Units on a scale
Standard Deviation 40.5
|
75.0 Units on a scale
Standard Deviation 37.2
|
63.8 Units on a scale
Standard Deviation 42.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Physical - 12 months
|
59.8 Units on a scale
Standard Deviation 42.3
|
85.0 Units on a scale
Standard Deviation 28.6
|
75.9 Units on a scale
Standard Deviation 38.9
|
68.9 Units on a scale
Standard Deviation 40.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Role Functioning - Physical - Early Termination
|
29.2 Units on a scale
Standard Deviation 40.1
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
29.2 Units on a scale
Standard Deviation 40.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain - Baseline
|
33.6 Units on a scale
Standard Deviation 19.2
|
36.6 Units on a scale
Standard Deviation 23.9
|
27.7 Units on a scale
Standard Deviation 19.1
|
32.7 Units on a scale
Standard Deviation 20.2
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain- 3 months
|
56.5 Units on a scale
Standard Deviation 24.3
|
61.0 Units on a scale
Standard Deviation 23.5
|
66.1 Units on a scale
Standard Deviation 24.9
|
59.8 Units on a scale
Standard Deviation 24.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain- 6 months
|
53.9 Units on a scale
Standard Deviation 19.9
|
64.9 Units on a scale
Standard Deviation 23.7
|
67.7 Units on a scale
Standard Deviation 25.2
|
59.5 Units on a scale
Standard Deviation 22.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain- 9 months
|
59.5 Units on a scale
Standard Deviation 21.6
|
69.3 Units on a scale
Standard Deviation 25.9
|
69.8 Units on a scale
Standard Deviation 22.5
|
64.0 Units on a scale
Standard Deviation 23.0
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain- 12 months
|
62.5 Units on a scale
Standard Deviation 19.1
|
74.0 Units on a scale
Standard Deviation 23.2
|
71.2 Units on a scale
Standard Deviation 27.9
|
67.0 Units on a scale
Standard Deviation 22.8
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Bodily Pain- Early Termination
|
25.7 Units on a scale
Standard Deviation 37.6
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
NA Units on a scale
Standard Deviation NA
Score not available as there were no participants who had an early termination visit in this group.
|
25.7 Units on a scale
Standard Deviation 37.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - Baseline
|
42.9 Units on a scale
Standard Deviation 19.4
|
41.9 Units on a scale
Standard Deviation 18.9
|
39.1 Units on a scale
Standard Deviation 16.4
|
41.8 Units on a scale
Standard Deviation 18.6
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - 3 months
|
51.7 Units on a scale
Standard Deviation 17.9
|
53.0 Units on a scale
Standard Deviation 20.8
|
59.0 Units on a scale
Standard Deviation 21.7
|
53.8 Units on a scale
Standard Deviation 19.5
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - 6 months
|
54.0 Units on a scale
Standard Deviation 16.6
|
61.6 Units on a scale
Standard Deviation 18.0
|
60.1 Units on a scale
Standard Deviation 23.7
|
57.0 Units on a scale
Standard Deviation 19.1
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - 9 months
|
54.9 Units on a scale
Standard Deviation 19.0
|
59.8 Units on a scale
Standard Deviation 19.1
|
65.7 Units on a scale
Standard Deviation 22.1
|
58.7 Units on a scale
Standard Deviation 20.3
|
|
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
General Health - 12 months
|
59.5 Units on a scale
Standard Deviation 20.2
|
65.0 Units on a scale
Standard Deviation 18.1
|
66.3 Units on a scale
Standard Deviation 23.0
|
62.3 Units on a scale
Standard Deviation 20.7
|
PRIMARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=40 Participants
|
Total
n=161 Participants
|
|---|---|---|---|---|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - Baseline
|
0.5 Units on a scale
Standard Deviation 0.3
|
0.5 Units on a scale
Standard Deviation 0.3
|
0.4 Units on a scale
Standard Deviation 0.3
|
0.5 Units on a scale
Standard Deviation 0.3
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - 3 months
|
0.7 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.2
|
0.7 Units on a scale
Standard Deviation 0.2
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - 6 months
|
0.7 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.1
|
0.8 Units on a scale
Standard Deviation 0.3
|
0.8 Units on a scale
Standard Deviation 0.2
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - 9 months
|
0.7 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.2
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - 12 months
|
0.8 Units on a scale
Standard Deviation 0.2
|
0.8 Units on a scale
Standard Deviation 0.1
|
0.8 Units on a scale
Standard Deviation 0.3
|
0.8 Units on a scale
Standard Deviation 0.2
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
EQ-5D - Early Termination
|
0.3 Units on a scale
Standard Deviation 0.5
|
1.0 Units on a scale
Standard Deviation NA
Only one patient completed this assessment at an early termination visit therefore a standard deviation value is not available.
|
NA Units on a scale
Standard Deviation NA
There were no patients who completed this assessment at an early termination visit in this group/arm.
|
0.4 Units on a scale
Standard Deviation 0.5
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - Baseline
|
49.0 Units on a scale
Standard Deviation 21.5
|
52.5 Units on a scale
Standard Deviation 24.8
|
40.2 Units on a scale
Standard Deviation 22.6
|
47.4 Units on a scale
Standard Deviation 22.7
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - 3 months
|
64.8 Units on a scale
Standard Deviation 22.0
|
68.7 Units on a scale
Standard Deviation 21.0
|
64.9 Units on a scale
Standard Deviation 25.6
|
65.5 Units on a scale
Standard Deviation 22.7
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - 6 months
|
59.5 Units on a scale
Standard Deviation 22.0
|
68.9 Units on a scale
Standard Deviation 23.3
|
68.7 Units on a scale
Standard Deviation 29.0
|
63.7 Units on a scale
Standard Deviation 24.5
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - 9 months
|
67.5 Units on a scale
Standard Deviation 21.0
|
67.8 Units on a scale
Standard Deviation 25.2
|
69.2 Units on a scale
Standard Deviation 25.0
|
68.0 Units on a scale
Standard Deviation 22.8
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - 12 months
|
73.2 Units on a scale
Standard Deviation 18.5
|
79.2 Units on a scale
Standard Deviation 16.0
|
71.5 Units on a scale
Standard Deviation 28.5
|
73.9 Units on a scale
Standard Deviation 21.2
|
|
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
Thermometer Scale - Early Termination
|
67.2 Units on a scale
Standard Deviation 29.1
|
100.0 Units on a scale
Standard Deviation NA
Only one patient completed this assessment at an early termination visit therefore a standard deviation value is not available.
|
NA Units on a scale
Standard Deviation NA
There were no patients who completed this assessment at an early termination visit in this group/arm.
|
71.9 Units on a scale
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: Baseline,months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=121 Participants
|
Total
|
|---|---|---|---|---|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
Baseline
|
5.4 Units on a scale
Standard Deviation 1.2
|
4.9 Units on a scale
Standard Deviation 1.1
|
5.3 Units on a scale
Standard Deviation 1.2
|
—
|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
3 months
|
3.8 Units on a scale
Standard Deviation 1.5
|
3.0 Units on a scale
Standard Deviation 1.1
|
3.7 Units on a scale
Standard Deviation 1.5
|
—
|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
6 months
|
3.4 Units on a scale
Standard Deviation 1.2
|
2.4 Units on a scale
Standard Deviation 1.0
|
3.2 Units on a scale
Standard Deviation 1.2
|
—
|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
9 months
|
3.7 Units on a scale
Standard Deviation 1.5
|
2.5 Units on a scale
Standard Deviation 1.0
|
3.4 Units on a scale
Standard Deviation 1.5
|
—
|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
12 months
|
3.4 Units on a scale
Standard Deviation 1.3
|
2.5 Units on a scale
Standard Deviation 1.0
|
3.2 Units on a scale
Standard Deviation 1.3
|
—
|
|
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
Early Termination
|
5.3 Units on a scale
Standard Deviation 1.8
|
2.1 Units on a scale
Standard Deviation 0.8
|
4.5 Units on a scale
Standard Deviation 2.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]).
Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=40 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
|
Total
|
|---|---|---|---|---|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
Baseline
|
6.0 Units on a scale
Standard Deviation 1.6
|
—
|
—
|
—
|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
3 months
|
2.8 Units on a scale
Standard Deviation 2.1
|
—
|
—
|
—
|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
6 months
|
2.0 Units on a scale
Standard Deviation 1.5
|
—
|
—
|
—
|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
9 months
|
2.4 Units on a scale
Standard Deviation 2.0
|
—
|
—
|
—
|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
12 months
|
2.5 Units on a scale
Standard Deviation 2.3
|
—
|
—
|
—
|
|
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
Early Termination
|
4.6 Units on a scale
Standard Deviation 3.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=121 Participants
|
Total
|
|---|---|---|---|---|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - Baseline
|
55.1 Units on a scale
Standard Deviation 19.6
|
52.0 Units on a scale
Standard Deviation 26.9
|
54.4 Units on a scale
Standard Deviation 21.4
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - 3 months
|
28.8 Units on a scale
Standard Deviation 21.1
|
29.0 Units on a scale
Standard Deviation 20.1
|
28.9 Units on a scale
Standard Deviation 20.8
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - 6 months
|
29.5 Units on a scale
Standard Deviation 20.2
|
23.1 Units on a scale
Standard Deviation 19.7
|
28.1 Units on a scale
Standard Deviation 20.2
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - 9 months
|
28.6 Units on a scale
Standard Deviation 19.5
|
17.9 Units on a scale
Standard Deviation 13.1
|
26.1 Units on a scale
Standard Deviation 18.7
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - 12 months
|
22.9 Units on a scale
Standard Deviation 16.8
|
19.4 Units on a scale
Standard Deviation 14.7
|
22.1 Units on a scale
Standard Deviation 16.3
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's PGA - Early Termination
|
57.0 Units on a scale
Standard Deviation 30.5
|
11.7 Units on a scale
Standard Deviation 12.6
|
47.3 Units on a scale
Standard Deviation 33.4
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - Baseline
|
60.0 Units on a scale
Standard Deviation 23.3
|
58.3 Units on a scale
Standard Deviation 27.6
|
59.6 Units on a scale
Standard Deviation 24.3
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - 3 months
|
32.4 Units on a scale
Standard Deviation 22.9
|
34.3 Units on a scale
Standard Deviation 22.3
|
32.8 Units on a scale
Standard Deviation 22.7
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - 6 months
|
32.1 Units on a scale
Standard Deviation 21.1
|
27.7 Units on a scale
Standard Deviation 21.9
|
31.1 Units on a scale
Standard Deviation 21.2
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - 9 months
|
32.2 Units on a scale
Standard Deviation 21.1
|
22.0 Units on a scale
Standard Deviation 16.9
|
29.9 Units on a scale
Standard Deviation 20.6
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - 12 months
|
26.1 Units on a scale
Standard Deviation 18.4
|
23.9 Units on a scale
Standard Deviation 15.9
|
25.6 Units on a scale
Standard Deviation 17.8
|
—
|
|
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's PGA - Early Termination
|
63.2 Units on a scale
Standard Deviation 29.5
|
21.7 Units on a scale
Standard Deviation 29.3
|
54.9 Units on a scale
Standard Deviation 33.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=121 Participants
|
Total
|
|---|---|---|---|---|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH - Baseline
|
51.4 Units on a scale
Standard Deviation 21.0
|
46.8 Units on a scale
Standard Deviation 23.7
|
50.4 Units on a scale
Standard Deviation 21.6
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH -3 months
|
29.9 Units on a scale
Standard Deviation 22.3
|
25.3 Units on a scale
Standard Deviation 19.3
|
28.9 Units on a scale
Standard Deviation 21.6
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH - 6 months
|
31.5 Units on a scale
Standard Deviation 21.4
|
26.2 Units on a scale
Standard Deviation 23.9
|
30.4 Units on a scale
Standard Deviation 21.9
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH - 9 months
|
31.3 Units on a scale
Standard Deviation 22.4
|
26.5 Units on a scale
Standard Deviation 24.5
|
30.2 Units on a scale
Standard Deviation 22.8
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH - 12 months
|
29.0 Units on a scale
Standard Deviation 24.1
|
26.2 Units on a scale
Standard Deviation 26.7
|
28.3 Units on a scale
Standard Deviation 24.6
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's GH - Early Termination
|
56.2 Units on a scale
Standard Deviation 28.6
|
11.7 Units on a scale
Standard Deviation 12.6
|
46.6 Units on a scale
Standard Deviation 31.8
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH - Baseline
|
55.3 Units on a scale
Standard Deviation 25.4
|
59.0 Units on a scale
Standard Deviation 24.8
|
56.1 Units on a scale
Standard Deviation 25.2
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH -3 months
|
33.6 Units on a scale
Standard Deviation 23.2
|
31.4 Units on a scale
Standard Deviation 23.4
|
33.1 Units on a scale
Standard Deviation 23.2
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH - 6 months
|
32.9 Units on a scale
Standard Deviation 22.3
|
29.4 Units on a scale
Standard Deviation 26.6
|
32.1 Units on a scale
Standard Deviation 23.2
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH -9 months
|
35.0 Units on a scale
Standard Deviation 22.7
|
26.9 Units on a scale
Standard Deviation 23.4
|
33.2 Units on a scale
Standard Deviation 23.0
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH -12 months
|
30.4 Units on a scale
Standard Deviation 23.7
|
30.6 Units on a scale
Standard Deviation 25.7
|
30.4 Units on a scale
Standard Deviation 24.0
|
—
|
|
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Patient's GH - Early Termination
|
62.5 Units on a scale
Standard Deviation 32.1
|
21.7 Units on a scale
Standard Deviation 29.3
|
53.8 Units on a scale
Standard Deviation 35.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=40 Participants
|
Total
n=161 Participants
|
|---|---|---|---|---|
|
Erythrocyte Sedimentation Rate
12 months
|
18.3 milligrams per deciliter (mg/dL)
Standard Deviation 13.4
|
10.5 milligrams per deciliter (mg/dL)
Standard Deviation 7.7
|
14.0 milligrams per deciliter (mg/dL)
Standard Deviation 12.8
|
15.9 milligrams per deciliter (mg/dL)
Standard Deviation 12.7
|
|
Erythrocyte Sedimentation Rate
Baseline
|
35.8 milligrams per deciliter (mg/dL)
Standard Deviation 22.9
|
31.7 milligrams per deciliter (mg/dL)
Standard Deviation 19.9
|
25.2 milligrams per deciliter (mg/dL)
Standard Deviation 15.7
|
32.4 milligrams per deciliter (mg/dL)
Standard Deviation 21.2
|
|
Erythrocyte Sedimentation Rate
3 months
|
25.3 milligrams per deciliter (mg/dL)
Standard Deviation 20.8
|
16.0 milligrams per deciliter (mg/dL)
Standard Deviation 13.9
|
12.4 milligrams per deciliter (mg/dL)
Standard Deviation 12.3
|
20.6 milligrams per deciliter (mg/dL)
Standard Deviation 18.8
|
|
Erythrocyte Sedimentation Rate
6 months
|
23.9 milligrams per deciliter (mg/dL)
Standard Deviation 21.9
|
12.3 milligrams per deciliter (mg/dL)
Standard Deviation 13.6
|
11.9 milligrams per deciliter (mg/dL)
Standard Deviation 10.2
|
19.0 milligrams per deciliter (mg/dL)
Standard Deviation 19.2
|
|
Erythrocyte Sedimentation Rate
9 months
|
24.2 milligrams per deciliter (mg/dL)
Standard Deviation 22.8
|
11.6 milligrams per deciliter (mg/dL)
Standard Deviation 10.2
|
11.9 milligrams per deciliter (mg/dL)
Standard Deviation 8.4
|
19.1 milligrams per deciliter (mg/dL)
Standard Deviation 19.4
|
|
Erythrocyte Sedimentation Rate
Early termination
|
47.3 milligrams per deciliter (mg/dL)
Standard Deviation 29.1
|
18.0 milligrams per deciliter (mg/dL)
Standard Deviation 26.5
|
10.5 milligrams per deciliter (mg/dL)
Standard Deviation 2.1
|
37.3 milligrams per deciliter (mg/dL)
Standard Deviation 30.5
|
SECONDARY outcome
Timeframe: Baseline, months 3,6,9,12Population: Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
Rheumatoid Arthritis (RA)
n=93 Participants
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 Participants
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=40 Participants
|
Total
n=161 Participants
|
|---|---|---|---|---|
|
C-Reactive Protein
Baseline
|
1.9 milligrams per deciliter (mg/dL)
Standard Deviation 2.5
|
1.1 milligrams per deciliter (mg/dL)
Standard Deviation 1.0
|
1.4 milligrams per deciliter (mg/dL)
Standard Deviation 1.4
|
1.7 milligrams per deciliter (mg/dL)
Standard Deviation 2.1
|
|
C-Reactive Protein
3 months
|
1.2 milligrams per deciliter (mg/dL)
Standard Deviation 2.5
|
0.7 milligrams per deciliter (mg/dL)
Standard Deviation 1.4
|
0.5 milligrams per deciliter (mg/dL)
Standard Deviation 0.6
|
0.9 milligrams per deciliter (mg/dL)
Standard Deviation 2.0
|
|
C-Reactive Protein
6 months
|
1.0 milligrams per deciliter (mg/dL)
Standard Deviation 2.2
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 1.0
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 0.6
|
0.8 milligrams per deciliter (mg/dL)
Standard Deviation 1.8
|
|
C-Reactive Protein
9 months
|
1.0 milligrams per deciliter (mg/dL)
Standard Deviation 2.6
|
0.2 milligrams per deciliter (mg/dL)
Standard Deviation 0.2
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 0.3
|
0.7 milligrams per deciliter (mg/dL)
Standard Deviation 2.1
|
|
C-Reactive Protein
12 months
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 0.4
|
0.2 milligrams per deciliter (mg/dL)
Standard Deviation 0.2
|
0.7 milligrams per deciliter (mg/dL)
Standard Deviation 1.6
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 0.9
|
|
C-Reactive Protein
Early Termination
|
3.5 milligrams per deciliter (mg/dL)
Standard Deviation 4.7
|
1.1 milligrams per deciliter (mg/dL)
Standard Deviation 2.1
|
0.4 milligrams per deciliter (mg/dL)
Standard Deviation 0.3
|
2.6 milligrams per deciliter (mg/dL)
Standard Deviation 4.1
|
Adverse Events
Rheumatoid Arthritis (RA)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Psoriasis Arthritis (PsA)
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Ankylosing Spondylitis (AS)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Total
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rheumatoid Arthritis (RA)
n=93 participants at risk
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 participants at risk
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Ankylosing Spondylitis (AS)
n=40 participants at risk
Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=161 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
3.6%
1/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Erysipelas
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Post procedural sepsis
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
3.6%
1/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
General disorders
Ulcer
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Investigations
Arthroscopy
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Surgical and medical procedures
Leg amputation
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
Other adverse events
| Measure |
Rheumatoid Arthritis (RA)
n=93 participants at risk
Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Psoriasis Arthritis (PsA)
n=28 participants at risk
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
|
Ankylosing Spondylitis (AS)
n=40 participants at risk
Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
|
Total
n=161 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Skin and subcutaneous tissue disorders
Uriticaria
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Surgical and medical procedures
Synovectomy
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Psychiatric disorders
Depression
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Influenza
|
0.00%
0/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
2.5%
1/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
3.6%
1/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/93 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/28 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.00%
0/40 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
0.62%
1/161 • Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
|
Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER