Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Multicenter Post Marketing Observational Study for the Evaluation of Quality of Life Outcomes and Tolerability of HUMIRA in Routine Clinical Use in Patients With RA PsA AS After Unsustainable Response to Disease Modifying Antirheumatic Drugs and or Biologicals

Conditions
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Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age greater than or equal to 18 Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA unsatisfactory NSAID response in patients with AS or unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS. Exclusion Criteria: Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC Patients participating in another study or clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid, Psoriatic Arthritis, Ankylosing Spondylitis<br>Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, patients with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monoclonals, Antibodies, Ankylosing Spondylitis, Antirheumatic Agents, Quality of Life, Adalimumab, rheumatoid arthritis, psoriatic arthritis