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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Collaborators:
Cato Research
JSS Medical Research Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01387802
First received: July 1, 2011
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    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:
  • BASDAI (Bath AS Disease Activity Index) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    This is a 100 VAS with 0 indicating lowest disease activity and 10 highest disease activity

  • BASFI (Bath AS Functional Assay) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    This is a 100 VAS with 0 indicating lowest functional limitations and 10 highest functional limitations

  • PASQ (Psoriasis and Arthritis Screening Questionnaire) [ Time Frame: Every 3 months up to 6 months, then every 6 months up to 24 months ] [ Designated as safety issue: No ]
    This is an 11 item tool that ascertains self reported presence of joint pain and swelling.


Estimated Enrollment: 1120
Study Start Date: July 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Biologic arm
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Offices of community rheumatologists

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387802

Contacts
Contact: Annie Daudrumez 514-832-7498 annie.daudrumez@abbvie.com
Contact: Josée Lafortune 514-832-7435 josee.lafortune@abbvie.com

  Show 109 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Cato Research
JSS Medical Research Inc.
Investigators
Study Director: Linda Assouline, PhD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01387802     History of Changes
Other Study ID Numbers: P12-672
Study First Received: July 1, 2011
Last Updated: October 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Assessing Effectiveness in Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014