Trial Outcomes & Findings for Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab (NCT NCT01282372)
NCT ID: NCT01282372
Last Updated: 2015-11-09
Results Overview
The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
COMPLETED
500 participants
Baseline (Day 1) and Month 24
2015-11-09
Participant Flow
The 'reason 1' and 'reason 2' for discontinuation for 'other' categories listed in participant flow is "relocation, regression of symptoms, pregnancy, and loss of insurance coverage" and "participant withdrew consent and loss of insurance coverage", respectively. AE = Adverse Event.
Participant milestones
| Measure |
Participants With Moderate to Severe Rheumatic Disease
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
421
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Participants With Moderate to Severe Rheumatic Disease
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
|
|---|---|
|
Overall Study
Lack of Efficacy / Exacerbation
|
25
|
|
Overall Study
Lost to Follow-up
|
23
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Refer Pre-Assignment Detail for Reason 1
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Presence of AE, Lack of Efficacy
|
1
|
|
Overall Study
Presence of AE, Regression of Symptoms
|
1
|
|
Overall Study
Refer Pre-Assignment Detail for Reason 2
|
1
|
|
Overall Study
Adverse Event
|
12
|
Baseline Characteristics
Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
Baseline characteristics by cohort
| Measure |
Participants With Moderate to Severe Rheumatic Disease
n=500 Participants
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
|
|---|---|
|
Age, Continuous
|
52.5 Years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=5 Participants
|
|
Employment Status
Housewife
|
127 Participants
n=5 Participants
|
|
Employment Status
Retired
|
118 Participants
n=5 Participants
|
|
Employment Status
Employee
|
116 Participants
n=5 Participants
|
|
Employment Status
Self-employed
|
95 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
35 Participants
n=5 Participants
|
|
Employment Status
Student
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=169 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Work Time Missed Due to Health Problem
Baseline
|
21.0 Impairment percentage
Standard Deviation 27.4
|
—
|
—
|
|
Mean Change From Baseline in Work Time Missed Due to Health Problem
Change from Baseline to Month 24
|
-18.9 Impairment percentage
Standard Deviation 28.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=166 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem
Baseline
|
52.8 Impairment percentage
Standard Deviation 26.2
|
—
|
—
|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem
Change from Baseline to Month 24
|
-40.0 Impairment percentage
Standard Deviation 31.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=159 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem
Baseline
|
57.8 Impairment percentage
Standard Deviation 26.9
|
—
|
—
|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem
Change from Baseline to Month 24
|
-46.8 Impairment percentage
Standard Deviation 31.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=500 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem
Baseline
|
62.1 Impairment percentage
Standard Deviation 24.2
|
—
|
—
|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem
Change from Baseline to Month 24
|
-47.0 Impairment percentage
Standard Deviation 27.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=41 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
n=59 Participants
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
n=69 Participants
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups
Baseline
|
20.7 Impairment percentage
Standard Deviation 25.3
|
24.8 Impairment percentage
Standard Deviation 31.1
|
17.8 Impairment percentage
Standard Deviation 25.0
|
|
Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups
Change from Baseline to Month 24 (N=22, 34, 44)
|
-25.5 Impairment percentage
Standard Deviation 28.6
|
-21.6 Impairment percentage
Standard Deviation 29.7
|
-13.5 Impairment percentage
Standard Deviation 26.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=40 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
n=57 Participants
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
n=69 Participants
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups
Baseline
|
57.0 Impairment percentage
Standard Deviation 24.4
|
49.3 Impairment percentage
Standard Deviation 26.9
|
53.3 Impairment percentage
Standard Deviation 26.7
|
|
Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups
Change from Baseline to Month 24 (N=21, 34, 43)
|
-50.5 Impairment percentage
Standard Deviation 25.0
|
-33.5 Impairment percentage
Standard Deviation 30.4
|
-40.0 Impairment percentage
Standard Deviation 33.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=40 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
n=53 Participants
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
n=66 Participants
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups
Baseline
|
62.3 Impairment percentage
Standard Deviation 25.1
|
53.9 Impairment percentage
Standard Deviation 27.4
|
58.3 Impairment percentage
Standard Deviation 27.6
|
|
Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups
Change from Baseline to Month 24 (N=21, 31, 42)
|
-55.2 Impairment percentage
Standard Deviation 26.0
|
-40.6 Impairment percentage
Standard Deviation 32.7
|
-47.1 Impairment percentage
Standard Deviation 32.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.
The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=184 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
n=166 Participants
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
n=150 Participants
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups
Baseline
|
64.5 Impairment percentage
Standard Deviation 24.4
|
59.4 Impairment percentage
Standard Deviation 23.3
|
62.1 Impairment percentage
Standard Deviation 24.9
|
|
Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups
Change from Baseline to Month 24 (N=155, 139, 127)
|
-47.5 Impairment percentage
Standard Deviation 28.2
|
-45.8 Impairment percentage
Standard Deviation 26.1
|
-47.6 Impairment percentage
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.
The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=184 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Disease Activity Score 28 (DAS28)
Baseline
|
5.95 Scores on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Mean Disease Activity Score 28 (DAS28)
Month 3 (N= 179)
|
4.05 Scores on a scale
Standard Deviation 1.35
|
—
|
—
|
|
Mean Disease Activity Score 28 (DAS28)
Month 6 (N=175)
|
3.39 Scores on a scale
Standard Deviation 1.26
|
—
|
—
|
|
Mean Disease Activity Score 28 (DAS28)
Month 12 (N=164)
|
3.08 Scores on a scale
Standard Deviation 1.27
|
—
|
—
|
|
Mean Disease Activity Score 28 (DAS28)
Month 18 (N=160)
|
2.90 Scores on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Mean Disease Activity Score 28 (DAS28)
Month 24 (N=153)
|
2.72 Scores on a scale
Standard Deviation 1.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.
The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=181 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline
|
1.60 Scores on a scale
Standard Deviation 0.61
|
—
|
—
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 3 (N=179)
|
0.98 Scores on a scale
Standard Deviation 0.62
|
—
|
—
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 6 (N=176)
|
0.77 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 12 (N=164)
|
0.65 Scores on a scale
Standard Deviation 0.54
|
—
|
—
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 18 (N=159)
|
0.58 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
|
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Month 24 (N=153)
|
0.51 Scores on a scale
Standard Deviation 0.53
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.
The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=146 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Baseline
|
5.75 Scores on a scale
Standard Deviation 1.67
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Month 3
|
3.34 Scores on a scale
Standard Deviation 1.71
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Month 6 (N=138)
|
2.51 Scores on a scale
Standard Deviation 1.55
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Month 12 (N=130)
|
2.05 Scores on a scale
Standard Deviation 1.48
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Month 18 (N=125)
|
1.69 Scores on a scale
Standard Deviation 1.24
|
—
|
—
|
|
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Month 24 (N=125)
|
1.50 Scores on a scale
Standard Deviation 1.28
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The PsARC score was not assessed in this study.
As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.
Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=166 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Baseline
|
98.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Month 3 (N=163)
|
72.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Month 6 (N=155)
|
48.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Month 12 (N=147)
|
34.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Month 18 (N=144)
|
32.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
TJC at Month 24 (N=139)
|
28.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Baseline
|
91.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Month 3 (N=163)
|
52.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Month 6 (N=155)
|
32.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Month 12 (N=147)
|
26.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Month 18 (N=144)
|
28.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero
SJC at Month 24 (N=139)
|
17.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.
Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=158 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Baseline
|
40.2 mm/hr
Standard Deviation 22.1
|
—
|
—
|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Month 3 (N=157)
|
25.3 mm/hr
Standard Deviation 15.4
|
—
|
—
|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Month 6 (N=150)
|
21.7 mm/hr
Standard Deviation 16.3
|
—
|
—
|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Month 12 (N=146)
|
18.5 mm/hr
Standard Deviation 13.3
|
—
|
—
|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Month 18 (N=140)
|
17.6 mm/hr
Standard Deviation 12.6
|
—
|
—
|
|
Mean Erythrocyte Sedimentation Rate (ESR)
Month 24 (N=137)
|
16.2 mm/hr
Standard Deviation 11.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.
Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=150 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Baseline
|
9.94 mg/L
Standard Deviation 13.93
|
—
|
—
|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Month 3 (N=144)
|
5.05 mg/L
Standard Deviation 9.48
|
—
|
—
|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Month 6 (N=140)
|
3.26 mg/L
Standard Deviation 6.49
|
—
|
—
|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Month 12 (N=141)
|
1.94 mg/L
Standard Deviation 3.05
|
—
|
—
|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Month 18 (N=137)
|
1.99 mg/L
Standard Deviation 3.60
|
—
|
—
|
|
Mean Plasma Concentrations of C-Reactive Protein (CRP)
Month 24 (N=133)
|
1.91 mg/L
Standard Deviation 4.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.
The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=166 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Baseline
|
65.80 Scores on a scale
Standard Deviation 16.90
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Month 3 (N=163)
|
32.00 Scores on a scale
Standard Deviation 19.40
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Month 6 (N=155)
|
21.90 Scores on a scale
Standard Deviation 18.20
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Month 12 (N=147)
|
15.10 Scores on a scale
Standard Deviation 13.90
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Month 18 (N=144)
|
14.10 Scores on a scale
Standard Deviation 13.20
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS pt at Month 24 (N=139)
|
12.00 Scores on a scale
Standard Deviation 13.60
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Baseline
|
62.55 Scores on a scale
Standard Deviation 16.70
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Month 3 (N=163)
|
29.30 Scores on a scale
Standard Deviation 19.40
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Month 6 (N=155)
|
19.67 Scores on a scale
Standard Deviation 17.40
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Month 12 (N=147)
|
14.20 Scores on a scale
Standard Deviation 15.10
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Month 18 (N=144)
|
12.75 Scores on a scale
Standard Deviation 12.10
|
—
|
—
|
|
Mean Visual Analogue Scale (VAS) Score
VAS ph at Month 24 (N=139)
|
11.31 Scores on a scale
Standard Deviation 13.90
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24Population: The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.
The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.
Outcome measures
| Measure |
Participants With Moderate to Severe Rheumatic Disease - RA
n=500 Participants
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - PsA
Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
|
Participants With Moderate to Severe Rheumatic Disease - AS
Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
|
|---|---|---|---|
|
Mean Sleep Disturbance Subscale Score
Baseline
|
50.9 Scores on a scale
Standard Deviation 23.6
|
—
|
—
|
|
Mean Sleep Disturbance Subscale Score
Month 3 (N=492)
|
30.3 Scores on a scale
Standard Deviation 18.0
|
—
|
—
|
|
Mean Sleep Disturbance Subscale Score
Month 6 (N=472)
|
23.4 Scores on a scale
Standard Deviation 16.7
|
—
|
—
|
|
Mean Sleep Disturbance Subscale Score
Month 12 (N=446)
|
19.7 Scores on a scale
Standard Deviation 16.9
|
—
|
—
|
|
Mean Sleep Disturbance Subscale Score
Month 18 (N=432)
|
18.3 Scores on a scale
Standard Deviation 15.7
|
—
|
—
|
|
Mean Sleep Disturbance Subscale Score
Month 24 (N=421)
|
16.6 Scores on a scale
Standard Deviation 15.6
|
—
|
—
|
Adverse Events
Participants With Moderate to Severe Rheumatic Disease
Serious adverse events
| Measure |
Participants With Moderate to Severe Rheumatic Disease
n=500 participants at risk
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Asthenia
|
0.40%
2/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Chills
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Fatigue
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Pain
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Pyrexia
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Immune system disorders
Anaphylactic shock
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Rash pustular
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
VIIth nerve injury
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Metabolism and nutrition disorders
Obesity
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid plexus papilloma
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Hypoaesthesia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Suffocation feeling
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Vascular disorders
Hypertension
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
Other adverse events
| Measure |
Participants With Moderate to Severe Rheumatic Disease
n=500 participants at risk
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Congenital, familial and genetic disorders
Sturge-Weber syndrome
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Flatulence
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Toothache
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Drug effect incomplete
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Drug ineffective
|
4.8%
24/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Influenza like illness
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Oedema peripheral
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Pain
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Peripheral swelling
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Polyp
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
General disorders
Pyrexia
|
2.0%
10/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Bronchitis
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Furuncle
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Gastroenteritis
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Herpes zoster
|
0.40%
2/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Metabolism and nutrition disorders
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Pharyngitis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Respiratory tract infection
|
2.6%
13/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Sinusitis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Tonsillitis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Tooth abscess
|
0.40%
2/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.80%
4/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
6/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Vaginal infection
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Infections and infestations
Viral infection
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Drug dose omission
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Foetal exposure during pregnancy
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
Blood glucose increased
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
C-reactive protein increased
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
Drug specific antibody present
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
Glycosylated hemoglobin increased
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Investigations
White blood cell count decreased
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.2%
11/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.40%
2/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Burning sensation
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Headache
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Memory impairment
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Nervous system disorders
Sciatica
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Normal newborn
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Psychiatric disorders
Anxiety disorder
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Psychiatric disorders
Depression
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Psychiatric disorders
Insomnia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Renal and urinary disorders
Albuminuria
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.60%
3/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
|
Vascular disorders
Hypertension
|
0.20%
1/500 • Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
|
Additional Information
Global Medical Information
AbbVie (prior sponsor, Abbott)
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