Ankylosing Spondylitis
Conditions
Keywords
Assessing Effectiveness in Ankylosing Spondylitis
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.
Interventions
None listed
Sponsors
JSS Medical Research Inc.
Cato Research
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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)) |
| 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
Canada
Outcome results
None listed