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| Name | Class |
|---|---|
| Group Data Management Biostatistics | UNKNOWN |
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The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis | Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do). | Baseline, months 3,6,9,12 |
| SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best). | Baseline, months 3,6,9,12 |
| EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status. | Baseline, months 3,6,9,12 |
| Measure | Description | Time Frame |
|---|---|---|
| DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value). |
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Inclusion Criteria:
In addition one of the following criteria must be fulfilled:
Exclusion Criteria:
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Primary care clinic and medical practice specialized in rheumatology
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Dworan-Timler, MD | Abbott AUSTRIA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator # 32372 | Amstetten | A-3300 | Austria | |||
| Site Reference ID/Investigator # 32368 |
A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis (RA) | Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. |
| FG001 | Psoriasis Arthritis (PsA) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline,months 3,6,9,12 |
| Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity. | Baseline, months 3,6,9,12 |
| Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). | Baseline, months 3,6,9,12 |
| Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state). | Baseline, months 3,6,9,12 |
| Erythrocyte Sedimentation Rate | Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement. | Baseline, months 3,6,9,12 |
| C-Reactive Protein | The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Baseline, months 3,6,9,12 |
| Bludenz |
| A-6700 |
| Austria |
| Site Reference ID/Investigator # 32367 | Gloggnitz | A-2640 | Austria |
| Site Ref # / Investigator 37123 | Graz | A-8020 | Austria |
| Site Ref # / Investigator 37125 | Innsbruck | A-6020 | Austria |
| Site Reference ID/Investigator # 32375 | Klagenfurt | A-9020 | Austria |
| Site Reference ID/Investigator # 32365 | Linz | A-4020 | Austria |
| Site Reference ID/Investigator # 32369 | Linz | A-4020 | Austria |
| Site Reference ID/Investigator # 32371 | Linz | A-4020 | Austria |
| Site Reference ID/Investigator # 32376 | Linz | A-4020 | Austria |
| Site Reference ID/Investigator # 32373 | Neudorf | A-2351 | Austria |
| Site Reference ID/Investigator # 32364 | Salzburg | A-5020 | Austria |
| Site Reference ID/Investigator # 18782 | Vienna | A-1030 | Austria |
| Site Reference ID/Investigator # 32363 | Vienna | A-1030 | Austria |
| Site Reference ID/Investigator # 32377 | Vienna | A-1100 | Austria |
| Site Reference ID/Investigator # 32378 | Vienna | A-1100 | Austria |
| Site Reference ID/Investigator # 32366 | Vienna | A-1140 | Austria |
| Site Reference ID/Investigator # 32374 | Vöcklabruck | A-4840 | Austria |
| Site Reference ID/Investigator # 32370 | Weiz | A-8160 | Austria |
| Site Ref # / Investigator 37124 | Wels | A-4600 | Austria |
Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
| FG002 | Ankylosing Spondylitis (AS) | Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis (RA) | Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. |
| BG001 | Psoriasis Arthritis (PsA) | Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. |
| BG002 | Ankylosing Spondylitis (AS) | Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Duration of underlying disease | Average duration (years) of underlying disease | Mean | Standard Deviation | years |
|
| 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 | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do). | Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best). | Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [participants who discontinued the study early]) in each disease group. No participants in the PsA or the AS group attended an early termination visit. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Primary | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status. | Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value). | Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline,months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity. | Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]). | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). | Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state). | Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Erythrocyte Sedimentation Rate | Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement. | Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, months 3,6,9,12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | C-Reactive Protein | The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, months 3,6,9,12 |
|
Adverse events and serious adverse events were collected throughout the study (12 months) and 70 days following the last dose of adalimumab.
A total of 15 out of 161 participants had at least one adverse event. Percentages for individual adverse events are calculated for each disease group (based on the number of participants in each group) as well as the total number of participants overall.
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 | Rheumatoid Arthritis (RA) | Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | 6 | 93 | 10 | 93 | ||
| EG001 | Psoriasis Arthritis (PsA) | Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | 2 | 28 | 1 | 28 | ||
| EG002 | Ankylosing Spondylitis (AS) | Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. | 0 | 40 | 1 | 40 | ||
| EG003 | Total | 8 | 161 | 12 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea infectious | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Uriticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Synovectomy | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| 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 |
Not provided
Not provided
| Male |
|
|
| 6 months |
|
| 9 months |
|
| 12 months |
|
| Early Termination |
|
Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
| OG002 | Ankylosing Spondylitis (AS) | Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. |
| OG003 | Total |
|
|
| Ankylosing Spondylitis (AS) |
Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. |
| OG003 | Total |
|
|
| Total |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Total |
|
|
| OG003 | Total |
|
|