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

This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
Collaborators:
CATO Research Canada
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: May 17, 2013
Last verified: May 2013
History of Changes
  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:

Drug Information available for: Adalimumab
U.S. FDA Resources

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

Contacts
Contact: Annie Daudrumez 514-832-7498 annie.daudrumez@abbvie.com
Contact: Chantal Lacasse 514-832-7728 chantal.daudrumez@abbvie.com

Locations
Canada
Site Reference ID/Investigator# 54758 Recruiting
Brampton, Canada, L6T 3J1
Principal Investigator: Site Reference ID/Investigator# 54758            
Site Reference ID/Investigator# 65502 Recruiting
Brockville, Canada, K2G 5J9
Principal Investigator: Site Reference ID/Investigator# 65502            
Site Reference ID/Investigator# 54764 Recruiting
Burlington, Canada, L7R 1E2
Principal Investigator: Site Reference ID/Investigator# 54764            
Site Reference ID/Investigator# 67347 Recruiting
Burlington, Canada, L7L 0B7
Principal Investigator: Site Reference ID/Investigator# 67347            
Site Reference ID/Investigator# 64274 Recruiting
Calgary, Canada, T3H 3T2
Principal Investigator: Site Reference ID/Investigator# 64274            
Site Reference ID/Investigator# 55242 Recruiting
Cranbrook, Canada, V1C 2R8
Principal Investigator: Site Reference ID/Investigator# 55242            
Site Reference ID/Investigator# 54748 Recruiting
Fredericton, Canada, E3B 6H5
Principal Investigator: Site Reference ID/Investigator# 54748            
Site Reference ID/Investigator# 55256 Recruiting
Fredericton, Canada, E3B 6H5
Principal Investigator: Site Reference ID/Investigator# 55256            
Site Reference ID/Investigator# 65011 Recruiting
Hamilton, Canada, L8M 1C6
Principal Investigator: Site Reference ID/Investigator# 65011            
Site Reference ID/Investigator# 54762 Recruiting
Hamilton, Canada, L8N 1Y2
Principal Investigator: Site Reference ID/Investigator# 54762            
Site Reference ID/Investigator# 55417 Recruiting
Hamilton, Canada, L8N 1Y2
Principal Investigator: Site Reference ID/Investigator# 55417            
Site Reference ID/Investigator# 54577 Recruiting
Kamloops, Canada, V2C 6G6
Principal Investigator: Site Reference ID/Investigator# 54577            
Site Reference ID/Investigator# 70093 Recruiting
Kitchener, Canada, N2M 5N6
Principal Investigator: Site Reference ID/Investigator# 70093            
Site Reference ID/Investigator# 54576 Recruiting
Laval, Canada, H7T 2P5
Principal Investigator: Site Reference ID/Investigator# 54576            
Site Reference ID/Investigator# 81877 Recruiting
Milton, Canada, L9T 2N2
Principal Investigator: Site Reference ID/Investigator# 81877            
Site Reference ID/Investigator# 54750 Recruiting
Mississauga, Canada, L5M 2V8
Principal Investigator: Site Reference ID/Investigator# 54750            
Site Reference ID/Investigator# 55401 Recruiting
Mississauga, Canada, L5B 4A2
Principal Investigator: Site Reference ID/Investigator# 55401            
Site Reference ID/Investigator# 54581 Recruiting
Mississauga, Canada, L5B 2P7
Principal Investigator: Site Reference ID/Investigator# 54581            
Site Reference ID/Investigator# 63655 Recruiting
Montreal, Canada, H3T 1E2
Principal Investigator: Site Reference ID/Investigator# 63655            
Site Reference ID/Investigator# 54754 Recruiting
Montreal, Canada, H3T 1Y3
Principal Investigator: Site Reference ID/Investigator# 54754            
Site Reference ID/Investigator# 54761 Recruiting
Montreal, Canada, H2L 1S6
Principal Investigator: Site Reference ID/Investigator# 54761            
Site Reference ID/Investigator# 55410 Recruiting
Nepean, Canada, K2G 6E2
Principal Investigator: Site Reference ID/Investigator# 55410            
Site Reference ID/Investigator# 55296 Recruiting
Ottawa, Canada, K2P 1V3
Principal Investigator: Site Reference ID/Investigator# 55296            
Site Reference ID/Investigator# 54574 Recruiting
Outremont, Canada, H2V 3Z5
Principal Investigator: Site Reference ID/Investigator# 54574            
Site Reference ID/Investigator# 54583 Recruiting
Owen Sound, Canada, N4K 6M9
Principal Investigator: Site Reference ID/Investigator# 54583            
Site Reference ID/Investigator# 67096 Recruiting
Penticton, Canada, V2A 3G7
Principal Investigator: Site Reference ID/Investigator# 67096            
Site Reference ID/Investigator# 55227 Recruiting
Prince George, Canada, V2L 5B6
Principal Investigator: Site Reference ID/Investigator# 55227            
Site Reference ID/Investigator# 45623 Recruiting
Quebec City, Canada, G1V 3M7
Principal Investigator: Site Reference ID/Investigator# 45623            
Site Reference ID/Investigator# 54765 Recruiting
Rimouski, Canada, G5L 8W1
Principal Investigator: Site Reference ID/Investigator# 54765            
Site Reference ID/Investigator# 55460 Recruiting
St-Leonard, Canada
Principal Investigator: Site Reference ID/Investigator# 55460            
Site Reference ID/Investigator# 67282 Recruiting
St. Catharines, Canada, L2N 7E4
Principal Investigator: Site Reference ID/Investigator# 67282            
Site Reference ID/Investigator# 54757 Recruiting
St. John's, Canada, A1A 5E8
Principal Investigator: Site Reference ID/Investigator# 54757            
Site Reference ID/Investigator# 55449 Recruiting
Toronto, Canada, M9V 4B8
Principal Investigator: Site Reference ID/Investigator# 55449            
Site Reference ID/Investigator# 55411 Recruiting
Toronto, Canada, M4S 2C6
Principal Investigator: Site Reference ID/Investigator# 55411            
Site Reference ID/Investigator# 54751 Recruiting
Toronto, Canada, M9C 5N2
Principal Investigator: Site Reference ID/Investigator# 54751            
Site Reference ID/Investigator# 54575 Recruiting
Toronto, Canada, M4X 1W4
Principal Investigator: Site Reference ID/Investigator# 54575            
Site Reference ID/Investigator# 55469 Recruiting
Trois-Rivieres, Canada, G8Z 1Y2
Principal Investigator: Site Reference ID/Investigator# 55469            
Site Reference ID/Investigator# 54572 Recruiting
Vancouver, Canada, V6Z 2E8
Principal Investigator: Site Reference ID/Investigator# 54572            
Site Reference ID/Investigator# 55197 Recruiting
Victoria, Canada
Principal Investigator: Site Reference ID/Investigator# 55197            
Site Reference ID/Investigator# 54580 Recruiting
Winnipeg, Canada, R3A 1M3
Principal Investigator: Site Reference ID/Investigator# 54580            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
CATO Research Canada
JSS Medical Research Inc.
Investigators
Study Director: Linda Assouline, PhD AbbVie
  More Information

Additional Information:
United States Prescribing Information is provided  This link exits the ClinicalTrials.gov site

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: May 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Assessing Effectiveness in Ankylosing Spondylitis

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

ClinicalTrials.gov processed this record on May 23, 2013