Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an improvement in work productivity in participants with rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and AS) and no data was available for the effect of adalimumab treatment on work productivity in PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted to evaluate the effect of treatment with adalimumab on work productivity and sleep disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and AS).
This was a multi-center, uncontrolled, prospective, observational study in participants with moderate to severe rheumatic disease (RA, PsA, or AS) who received adalimumab under normal clinical practice in accordance with Summary of Product Characteristics (SmPC), with or without other anti-rheumatic treatments.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Work Time Missed Due to Health Problem | 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. | Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Impairment While Working Due to Health Problem | 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. | Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Overall Work Impairment Due to Health Problem | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label, as prescribed by the physicians under normal clinical practice.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Theofilos Karatsourakis, MD | AbbVie Pharmaceuticals S.A. | Study Chair |
Not provided
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
Up to 2 years from signing of informed consent
The occurrence, type, severity, and relationship of adverse events to adalimumab were assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Overall Activity Impairment Due to Health Problem | 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. | Baseline (Day 1) and Month 24 |
| Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups | 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. | Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups | 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. | Baseline (Day 1) and Month 24 |
| Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups | 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. | Baseline (Day 1) and Month 24 |
| Mean Disease Activity Score 28 (DAS28) | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Psoriatic Arthritis Response Criteria (PsARC) Score | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Erythrocyte Sedimentation Rate (ESR) | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Plasma Concentrations of C-Reactive Protein (CRP) | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Visual Analogue Scale (VAS) Score | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Mean Sleep Disturbance Subscale Score | 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. | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Refer Pre-Assignment Detail for Reason 1 |
|
| Death |
|
| Presence of AE, Lack of Efficacy |
|
| Presence of AE, Regression of Symptoms |
|
| Refer Pre-Assignment Detail for Reason 2 |
|
| Adverse Event |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Employment Status | Number | Participants |
|
| OG000 |
| Participants With Moderate to Severe Rheumatic Disease - RA |
Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label |
| OG001 | Participants With Moderate to Severe Rheumatic Disease - PsA | Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label |
| OG002 | Participants With Moderate to Severe Rheumatic Disease - AS | Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label |
|
|
| Primary | Mean Change From Baseline in Work Time Missed Due to Health Problem | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Secondary | Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Primary | Mean Change From Baseline in Impairment While Working Due to Health Problem | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Secondary | Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Primary | Mean Change From Baseline in Overall Work Impairment Due to Health Problem | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Secondary | Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Primary | Mean Change From Baseline in Overall Activity Impairment Due to Health Problem | 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. | 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. | Posted | Mean | Standard Deviation | Impairment percentage | Baseline (Day 1) and Month 24 |
|
|
|
| Secondary | Mean Disease Activity Score 28 (DAS28) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Psoriatic Arthritis Response Criteria (PsARC) Score | 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. | The PsARC score was not assessed in this study. | Posted | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
| Secondary | Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero | 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. | The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points. | Posted | Number | Percentage of participants | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Erythrocyte Sedimentation Rate (ESR) | 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. | The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points. | Posted | Mean | Standard Deviation | mm/hr | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Plasma Concentrations of C-Reactive Protein (CRP) | 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. | The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points. | Posted | Mean | Standard Deviation | mg/L | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Visual Analogue Scale (VAS) Score | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Mean Sleep Disturbance Subscale Score | 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. | The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| 33 |
| 500 |
| 158 |
| 500 |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| VIIth nerve injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Choroid plexus papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Suffocation feeling | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sturge-Weber syndrome | Congenital, familial and genetic disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Drug effect incomplete | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Polyp | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypertransaminasemia | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Metabolism and nutrition disorders | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Drug dose omission | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Foetal exposure during pregnancy | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Drug specific antibody present | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Glycosylated hemoglobin increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Normal newborn | Pregnancy, puerperium and perinatal conditions | MedDRA version 17.1 | Non-systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Mesangioproliferative glomerulonephritis | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Guttate psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
|
|
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=164) |
|
| Month 18 (N=160) |
|
| Month 24 (N=153) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=164) |
|
| Month 18 (N=159) |
|
| Month 24 (N=153) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=130) |
|
| Month 18 (N=125) |
|
| Month 24 (N=125) |
|
| Title | Measurements |
|---|---|
|
| TJC at Month 12 (N=147) |
|
| TJC at Month 18 (N=144) |
|
| TJC at Month 24 (N=139) |
|
| SJC at Baseline |
|
| SJC at Month 3 (N=163) |
|
| SJC at Month 6 (N=155) |
|
| SJC at Month 12 (N=147) |
|
| SJC at Month 18 (N=144) |
|
| SJC at Month 24 (N=139) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=146) |
|
| Month 18 (N=140) |
|
| Month 24 (N=137) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=141) |
|
| Month 18 (N=137) |
|
| Month 24 (N=133) |
|
| Title | Measurements |
|---|---|
|
| VAS pt at Month 12 (N=147) |
|
| VAS pt at Month 18 (N=144) |
|
| VAS pt at Month 24 (N=139) |
|
| VAS ph at Baseline |
|
| VAS ph at Month 3 (N=163) |
|
| VAS ph at Month 6 (N=155) |
|
| VAS ph at Month 12 (N=147) |
|
| VAS ph at Month 18 (N=144) |
|
| VAS ph at Month 24 (N=139) |
|
| Title | Measurements |
|---|---|
|
| Month 12 (N=446) |
|
| Month 18 (N=432) |
|
| Month 24 (N=421) |
|