Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Registration Number
- NCT01387802
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 722
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis Every 3 months up to 6 months, then every 6 months up to 24 months 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))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease Every 3 months up to 6 months, then every 6 months up to 24 months 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))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia Every 3 months up to 6 months, then every 6 months up to 24 months 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))
Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis Every 3 months up to 6 months, then every 6 months up to 24 months 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))
- Secondary Outcome Measures
Name Time Method BASDAI (Bath AS Disease Activity Index) Every 3 months up to 6 months, then every 6 months up to 24 months This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity
BASFI (Bath AS Functional Assay) Every 3 months up to 6 months, then every 6 months up to 24 months This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations
PASQ (Psoriasis and Arthritis Screening Questionnaire) Every 3 months up to 6 months, then every 6 months up to 24 months This is an 11 item tool that ascertains self reported presence of joint pain and swelling.
Trial Locations
- Locations (56)
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
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