Trial Outcomes & Findings for Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab (NCT NCT01273519)
NCT ID: NCT01273519
Last Updated: 2014-03-26
Results Overview
Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Recruitment status
COMPLETED
Target enrollment
155 participants
Primary outcome timeframe
Baseline, Months 3, 6, 9, 12
Results posted on
2014-03-26
Participant Flow
Participant milestones
| Measure |
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Rheumatoid Arthiritis (RA)
Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Psoriatic Arthritis (PsA)
Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
78
|
30
|
|
Overall Study
COMPLETED
|
39
|
59
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
19
|
5
|
Reasons for withdrawal
| Measure |
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Rheumatoid Arthiritis (RA)
Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Psoriatic Arthritis (PsA)
Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
8
|
3
|
|
Overall Study
Other
|
1
|
6
|
1
|
Baseline Characteristics
Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthiritis (RA)
n=78 Participants
Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Psoriatic Arthritis (PsA)
n=30 Participants
Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
n=47 Participants
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.76 years
STANDARD_DEVIATION 13.11 • n=5 Participants
|
48.07 years
STANDARD_DEVIATION 12.71 • n=7 Participants
|
42.02 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 13.56 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Outcome measures
| Measure |
RA, PsA, AS
n=152 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Baseline, n=152
|
58.32 units on a scale
Standard Deviation 22.01
|
—
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 3, n=143
|
34.28 units on a scale
Standard Deviation 24.74
|
—
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 6, n=116
|
27.14 units on a scale
Standard Deviation 22.69
|
—
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 9, n=112
|
21.71 units on a scale
Standard Deviation 20.21
|
—
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 12, n=105
|
14.62 units on a scale
Standard Deviation 16.88
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Outcome measures
| Measure |
RA, PsA, AS
n=152 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Baseline, n=152
|
56.55 units on a scale
Standard Deviation 21.57
|
—
|
—
|
|
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 3, n=141
|
31.19 units on a scale
Standard Deviation 23.95
|
—
|
—
|
|
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 6, n=114
|
25.32 units on a scale
Standard Deviation 22.13
|
—
|
—
|
|
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 9, n=108
|
19.06 units on a scale
Standard Deviation 18.46
|
—
|
—
|
|
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 12, n=105
|
12.2 units on a scale
Standard Deviation 15.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment at time point.
Participants measured their present pain intensity by specifying their level of pain in response to the question "How intensive is your pain at present?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Outcome measures
| Measure |
RA, PsA, AS
n=150 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=105 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
No Pain
|
4 participants
|
49 participants
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Mild Pain
|
22 participants
|
40 participants
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Moderate Pain
|
61 participants
|
14 participants
|
—
|
|
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Severe Pain
|
63 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Outcome measures
| Measure |
RA, PsA, AS
n=150 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Baseline, n=150
|
64.31 units on a scale
Standard Deviation 19.79
|
—
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 3, n=142
|
38.24 units on a scale
Standard Deviation 25.12
|
—
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 6, n=114
|
30.89 units on a scale
Standard Deviation 21.5
|
—
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 9, n=109
|
24.74 units on a scale
Standard Deviation 20.3
|
—
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Month 12, n=105
|
17.36 units on a scale
Standard Deviation 17.57
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment.
Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question "How intensive was your pain on average in the past 3 months?" on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Outcome measures
| Measure |
RA, PsA, AS
n=150 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=105 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
No pain
|
0 participants
|
40 participants
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Mild
|
10 participants
|
44 participants
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Moderate
|
71 participants
|
19 participants
|
—
|
|
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Severe
|
69 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).
Outcome measures
| Measure |
RA, PsA, AS
n=150 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=87 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Intermittent
|
41 participants
|
42 participants
|
—
|
|
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Mostly daytime
|
18 participants
|
22 participants
|
—
|
|
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Mostly nocturnal
|
26 participants
|
13 participants
|
—
|
|
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Continuous
|
65 participants
|
10 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.
Outcome measures
| Measure |
RA, PsA, AS
n=141 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=86 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
Sudden
|
40 participants
|
30 participants
|
—
|
|
Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
Creeping
|
101 participants
|
56 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment.
Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.
Outcome measures
| Measure |
RA, PsA, AS
n=148 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=103 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Never
|
3 participants
|
41 participants
|
—
|
|
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Rarely
|
14 participants
|
42 participants
|
—
|
|
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Every night
|
57 participants
|
3 participants
|
—
|
|
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
More than once a night per week
|
74 participants
|
17 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: All participants with an assessment.
Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.
Outcome measures
| Measure |
RA, PsA, AS
n=150 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=104 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Moderately distressed by pain
|
71 participants
|
18 participants
|
—
|
|
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
No pain
|
0 participants
|
33 participants
|
—
|
|
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Not distressed by pain
|
0 participants
|
23 participants
|
—
|
|
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Slightly distressed by pain
|
10 participants
|
28 participants
|
—
|
|
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Greatly distressed by pain
|
69 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 \[worst\] to 100 \[best \]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.
Outcome measures
| Measure |
RA, PsA, AS
n=144 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Physical functioning: Baseline, n=143
|
46.9 units on a scale
Standard Deviation 26.0
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Physical functioning: Month 3, n=131
|
62.1 units on a scale
Standard Deviation 28.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Physical functioning: Month 6, n=104
|
66.9 units on a scale
Standard Deviation 27.4
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Physical functioning: Month 9, n=96
|
71.9 units on a scale
Standard Deviation 25.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Physical functioning: Month 12, n=94
|
77.1 units on a scale
Standard Deviation 25.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning physical: Baseline, n=142
|
16.7 units on a scale
Standard Deviation 33.0
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning physical: Month 3, n=129
|
42.4 units on a scale
Standard Deviation 44.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning physical: Month 6, n=103
|
48.8 units on a scale
Standard Deviation 44.5
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning physical: Month 9, n=96
|
54.7 units on a scale
Standard Deviation 44.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Bodily pain: Baseline, n=144
|
27.2 units on a scale
Standard Deviation 19.0
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Bodily pain: Month 3, n=131
|
52.1 units on a scale
Standard Deviation 25.6
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Bodily pain: Month 6, n=104
|
56.3 units on a scale
Standard Deviation 24.1
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Bodily pain: Month 9, n=96
|
62.8 units on a scale
Standard Deviation 23.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Bodily pain: Month 12, n=95
|
73.2 units on a scale
Standard Deviation 23.2
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
General health: Baseline, n=141
|
38.3 units on a scale
Standard Deviation 16.5
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
General health: Month 3, n=131
|
46.6 units on a scale
Standard Deviation 19.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
General health: Month 6, n=104
|
49.9 units on a scale
Standard Deviation 18.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
General health: Month 9, n=96
|
58.3 units on a scale
Standard Deviation 20.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
General health: Month 12, n=95
|
64.9 units on a scale
Standard Deviation 21.4
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Vitality: Baseline, n=144
|
36.6 units on a scale
Standard Deviation 18.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Vitality: Month 3, n=131
|
51.3 units on a scale
Standard Deviation 21.4
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Vitality: Month 6, n=104
|
56.3 units on a scale
Standard Deviation 21.6
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Vitality: Month 9, n=96
|
61.4 units on a scale
Standard Deviation 20.1
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Vitality: Month 12, n=95
|
68.0 units on a scale
Standard Deviation 18.7
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Social functioning: Baseline, n=142
|
42.5 units on a scale
Standard Deviation 23.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Social functioning: Month 3, n=130
|
62.6 units on a scale
Standard Deviation 25.4
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Social functioning: Month 6, n=104
|
66.7 units on a scale
Standard Deviation 25.1
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Social functioning: Month 9, n=96
|
72.7 units on a scale
Standard Deviation 23.7
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Social functioning: Month 12, n=94
|
82.4 units on a scale
Standard Deviation 19.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning emotional: Baseline, n=143
|
38.0 units on a scale
Standard Deviation 43.6
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning emotional: Month 3, n=128
|
60.7 units on a scale
Standard Deviation 45.7
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning emotional: Month 6, n=103
|
61.2 units on a scale
Standard Deviation 43.1
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning emotional: Month 9, n=96
|
76.0 units on a scale
Standard Deviation 39.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning emotional: Month 12, n=95
|
85.6 units on a scale
Standard Deviation 31.8
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Mental health: Baseline, n=143
|
48.9 units on a scale
Standard Deviation 18.5
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Mental health: Month 3, n=131
|
63.0 units on a scale
Standard Deviation 19.1
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Mental health: Month 6, n=103
|
67.5 units on a scale
Standard Deviation 19.7
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Mental health: Month 9, n=94
|
72.1 units on a scale
Standard Deviation 18.9
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Mental health: Month 12, n=95
|
77.1 units on a scale
Standard Deviation 18.0
|
—
|
—
|
|
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
Role functioning physical: Month 12, n=93
|
63.4 units on a scale
Standard Deviation 44.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI \< 0.5.
Outcome measures
| Measure |
RA, PsA, AS
n=73 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=28 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
n=6 Participants
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Baseline, n=73, 28, 6
|
1.31 units on a scale
Standard Deviation 0.69
|
0.85 units on a scale
Standard Deviation 0.57
|
0.88 units on a scale
Standard Deviation 0.62
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 3, n=66, 26, 2
|
0.94 units on a scale
Standard Deviation 0.72
|
0.62 units on a scale
Standard Deviation 0.64
|
0.75 units on a scale
Standard Deviation 0.35
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 12, n=48, 22, 0
|
0.68 units on a scale
Standard Deviation 0.72
|
0.51 units on a scale
Standard Deviation 0.57
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 6, n=53, 19, 0
|
0.87 units on a scale
Standard Deviation 0.78
|
0.77 units on a scale
Standard Deviation 0.69
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 9, n=46, 21, 0
|
0.83 units on a scale
Standard Deviation 0.71
|
0.54 units on a scale
Standard Deviation 0.54
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Outcome measures
| Measure |
RA, PsA, AS
n=72 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=27 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
n=5 Participants
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Month 9, n=46, 20, 0
|
2.19 units on a scale
Standard Deviation 1.81
|
1.81 units on a scale
Standard Deviation 1.86
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
|
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Baseline, n=72, 27, 5
|
5.46 units on a scale
Standard Deviation 1.6
|
4.72 units on a scale
Standard Deviation 1.69
|
4.61 units on a scale
Standard Deviation 2.57
|
|
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Month 3, n=67, 22, 2
|
3.78 units on a scale
Standard Deviation 2.14
|
2.41 units on a scale
Standard Deviation 1.63
|
4.23 units on a scale
Standard Deviation 2.15
|
|
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Month 6, n=53, 18, 0
|
2.74 units on a scale
Standard Deviation 2.1
|
2.34 units on a scale
Standard Deviation 2.06
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
|
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
Month 12, n=49, 21, 0
|
1.72 units on a scale
Standard Deviation 1.83
|
1.55 units on a scale
Standard Deviation 1.91
|
NA units on a scale
Standard Deviation NA
no participants had an assessment at this time point
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible") is used to answer the questions on the test.
Outcome measures
| Measure |
RA, PsA, AS
n=72 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Baseline, n=72
|
5.46 units on a scale
Standard Deviation 1.6
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 3, n=67
|
3.78 units on a scale
Standard Deviation 2.14
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 6, n=53
|
2.74 units on a scale
Standard Deviation 2.1
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 9, n=46
|
2.19 units on a scale
Standard Deviation 1.81
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
Month 12, n=49
|
1.72 units on a scale
Standard Deviation 1.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).
Outcome measures
| Measure |
RA, PsA, AS
n=45 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Baseline, n=45
|
5.65 units on a scale
Standard Deviation 2.25
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Month 3, n=44
|
3.24 units on a scale
Standard Deviation 2.25
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Month 6, n=39
|
2.62 units on a scale
Standard Deviation 2.55
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Month 9, n=34
|
1.97 units on a scale
Standard Deviation 2.15
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
Month 12, n=32
|
1.23 units on a scale
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.
Outcome measures
| Measure |
RA, PsA, AS
n=69 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=25 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
n=40 Participants
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Baseline, n=69, 25, 40
|
32.87 mm/h
Standard Deviation 17.89
|
23.96 mm/h
Standard Deviation 19.41
|
28.58 mm/h
Standard Deviation 22.87
|
|
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Month 3, n=68, 25, 40
|
21.95 mm/h
Standard Deviation 18.25
|
13.4 mm/h
Standard Deviation 15.05
|
12.45 mm/h
Standard Deviation 10.33
|
|
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Month 6, n=58, 21, 37
|
21.98 mm/h
Standard Deviation 19.22
|
14.81 mm/h
Standard Deviation 16.62
|
13.24 mm/h
Standard Deviation 10.29
|
|
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Month 9, n=51, 23, 33
|
25.49 mm/h
Standard Deviation 22.45
|
14.09 mm/h
Standard Deviation 16.9
|
12.79 mm/h
Standard Deviation 7.75
|
|
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
Month 12, n=49, 21, 30
|
19.94 mm/h
Standard Deviation 19.63
|
13.33 mm/h
Standard Deviation 15.32
|
12.0 mm/h
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12Population: All participants with an assessment. n=number of participants with an assessment at time point.
The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.
Outcome measures
| Measure |
RA, PsA, AS
n=57 Participants
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
RA, PsA, AS: Month 12
n=21 Participants
Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
Ankylosing Spondylitis (AS)
n=39 Participants
Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|---|---|
|
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Baseline, n=57, 21, 39
|
1.83 mg/dL
Standard Deviation 2.65
|
1.56 mg/dL
Standard Deviation 3.25
|
1.18 mg/dL
Standard Deviation 1.69
|
|
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Month 3, n=61, 22, 39
|
4.3 mg/dL
Standard Deviation 10.88
|
2.31 mg/dL
Standard Deviation 7.39
|
0.84 mg/dL
Standard Deviation 1.89
|
|
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Month 6, n=50, 17, 35
|
1.95 mg/dL
Standard Deviation 4.03
|
1.25 mg/dL
Standard Deviation 1.94
|
1.57 mg/dL
Standard Deviation 3.14
|
|
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Month 9, n=44, 17, 32
|
2.16 mg/dL
Standard Deviation 3.85
|
5.33 mg/dL
Standard Deviation 12.96
|
1.14 mg/dL
Standard Deviation 2.35
|
|
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
Month 12, n=45, 18, 31
|
1.73 mg/dL
Standard Deviation 3.89
|
2.42 mg/dL
Standard Deviation 5.36
|
1.26 mg/dL
Standard Deviation 3.31
|
Adverse Events
RA, PsA, AS
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RA, PsA, AS
n=155 participants at risk
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|
|
Nervous system disorders
Carotid artery stenosis
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Infections and infestations
Respiratory tract infection
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
General disorders
Treatment failure
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
Other adverse events
| Measure |
RA, PsA, AS
n=155 participants at risk
Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
|
|---|---|
|
Immune system disorders
Drug ineffective
|
11.0%
17/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Psychiatric disorders
Sleep disorder
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Psychiatric disorders
Depression
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Musculoskeletal and connective tissue disorders
Intervetebral disc protrusion
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Infections and infestations
Arthritis reactive
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
|
Investigations
C-reactive protein increased
|
0.65%
1/155 • All serious adverse events were reported from the time of informed consent (and adverse events were reported from Baseline) until 70 days following the intake of the last dose of physician-prescribed treatment. Duration of study was 871 days.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER