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

AbbVie (prior sponsor, Abbott)722 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

722

Conditions

Ankylosing Spondylitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (56)

Outcomes

Primary Outcomes

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))

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Rheumatology Clinic /ID# 54768

Calgary, Alberta, Canada

Associate Clinic /ID# 64274

Calgary, Alberta, Canada

Pont, Cranbrook, BC, CA /ID# 55242

Cranbrook, British Columbia, Canada

Dr. Barbara T. Blumenauer Inc. /ID# 55226

Kamloops, British Columbia, Canada

Hudson, Kamloops, Canada /ID# 54577

Kamloops, British Columbia, Canada

Dr. Maqbool R. Sheriff Inc. /ID# 55247

Nanaimo, British Columbia, Canada

Stewart, Penticton, CA /ID# 67096

Penticton, British Columbia, Canada

Dr. Michael Buchanan, Inc. /ID# 55227

Prince George, British Columbia, Canada

Dr. J. Antonio Avina-Zubieta /ID# 68263

Richmond, British Columbia, Canada

Dr. Alfonso Verdejo Inc. /ID# 54572

Vancouver, British Columbia, Canada

...and 46 more locations

Secondary Outcomes

BASFI (Bath AS Functional Assay)

This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations

Time frame: 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.

Time frame: 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

Time frame: Every 3 months up to 6 months, then every 6 months up to 24 months