Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis

Study Overview
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Brief Summary
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The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).

Official Title
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Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)

Conditions
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Psoriatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult >= 18 years old Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel Active Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA Exclusion Criteria: Currently participating in another prospective study including controlled clinical trials and observational studies Patient cannot or will not sign informed consent Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated Previous treatment with anti-tumor necrosis factor (anti-TNF) or other biologic agent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| adalimumab<br>Responding to treatment with non-biologic DMARDs (disease-modifying antirheumatic drugs) and initiated on treatment with adalimumab as monotherapy or in combination with other medications | |
| DMARD (disease-modifying antirheumatic drugs)<br>Initiated on non-biologic DMARD(disease-modifying antirheumatic drugs) or requiring switching to another non biologic DMARD (disease-modifying antirheumatic drugs) as monotherapy, or in combination with other medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Disease Activity Score - 28 (DAS-28) | The DAS - 28 is calculated using the number of swollen (SJC) and tender (TJC) joints out of 28, the erythrocyte sedimentation rate (ESR) and the patient's global assessment of disease activity using a 100 mm visual analogue scale (VAS) | Every 3 months up to 6 months, then every 6 months up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Morning Stiffness (min) | This is ascertained by the treating physician during the patient assessment and is measured in minutes | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Dermatology Life Quality Index (DLQI) | This is a self-administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease. The 10 questions in the DLQI converge into six domains that measure symptoms and feelings, daily activities, leisure, work and / or school, personal relationships and satisfaction with treatment. | Baseline, month 6, month12, month 24 | 
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | Self-administered questionnaire measuring the patient's functional ability during the last week. | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Patient Global Assessment of Disease Activity (VAS and 5 Point Scale) | A 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity and a five point Likert Scale (0 - 4) that is completed by the patient at the physician's office | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Physician Global Assessment of Disease Activity (VAS and 5 Point Scale) | This is a 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity a five point Likert Scale (0 - 4) that is completed by the physician during the patient examination | Every 3 months up to 6 months, then every 6 months up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assessing Effectiveness in Psoriatic Arthritis