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Completed

NCT Number: NCT01387802

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Associate Clinic /ID# 64274, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis

    Time frame: 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))

  2. 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

    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))

  3. 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

    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))

  4. Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia

    Time frame: 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 outcomes

  1. BASFI (Bath AS Functional Assay)

    Time frame: 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

  2. PASQ (Psoriasis and Arthritis Screening Questionnaire)

    Time frame: 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.

  3. BASDAI (Bath AS Disease Activity Index)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Cato Research
  • JSS Medical Research Inc.

Registry information

Official study title

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

Acronym: Complete-AS

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2011
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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