Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis

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 Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.

Official Title
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Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)

Conditions
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Ankylosing Spondylitis

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 Ankylosing Spondylitis as per the judgment of the treating physician Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS 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-TNF (Tumor Necrosis Factor) or other biologic agent Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS

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 |
| --- | --- |
| Non-Biologic arm<br>Patients that have not responded to the current treatment with an NSAID (Nonsteroidal Anti-Inflammatory Drug) and/or non - biologic DMARD (Disease-Modifying Anti Rheumatic Drug) for peripheral joint involvement and switch to or addition of another NSAID /DMARDS | |
| Biologic arm<br>Patients that have not responded to the current treatment with non biologic DMARDS (Disease-Modifying Anti Rheumatic Drug) /NSAID (Nonsteroidal Anti-Inflammatory Drug) and switch to or addition of adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis | Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe)) | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis | Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe)) | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease | Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe)) | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia | Baseline will be assessed as follows: Never Present, Positive History (Not present- Complete Remission,Time since remission onset; Present- Assessment of severity using a five point Likert scale (0 = Absent (Clear for Psoriasis); 5 = Most Severe)) Follow-up visits will be assessed as follows:Not present (Never present, Complete remission) Present (New Onset or Recurrence, Assessment of severity using a five point Likert scale (0 = Absent; 5 = Most Severe)) | Every 3 months up to 6 months, then every 6 months up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BASFI (Bath AS Functional Assay) | This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| PASQ (Psoriasis and Arthritis Screening Questionnaire) | This is an 11 item tool that ascertains self reported presence of joint pain and swelling. | Every 3 months up to 6 months, then every 6 months up to 24 months | 
| BASDAI (Bath AS Disease Activity Index) | This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity | 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 Ankylosing Spondylitis