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 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 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))
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (56)
Dr. Barbara T. Blumenauer Inc. /ID# 55226
🇨🇦Kamloops, British Columbia, Canada
Ecker, Fredericton, CA /ID# 54748
🇨🇦Fredericton, New Brunswick, Canada
Pont, Cranbrook, BC, CA /ID# 55242
🇨🇦Cranbrook, 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
Dr. Milton F. Baker Inc. /ID# 55197
🇨🇦Victoria, British Columbia, Canada
Bulleid Henderson Prof. Corp. /ID# 55256
🇨🇦Fredericton, New Brunswick, Canada
Nexus Clinical Research /ID# 54757
🇨🇦St. John's, Newfoundland and Labrador, Canada
St. Clare's Mercy Hospital /ID# 54767
🇨🇦St. John's, Newfoundland and Labrador, Canada
Credit Valley Rheumatology /ID# 54750
🇨🇦Mississauga, Ontario, Canada
Karasik, Toronto, CA /ID# 54751
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital /ID# 63655
🇨🇦Montreal, Quebec, Canada
Rheumatology Clinic /ID# 54768
🇨🇦Calgary, Alberta, Canada
Associate Clinic /ID# 64274
🇨🇦Calgary, Alberta, Canada
Manitoba Clinic /ID# 54580
🇨🇦Winnipeg, Manitoba, Canada
Qe Ii Hsc /Id# 55261
🇨🇦Halifax, Nova Scotia, Canada
Dr. Juris Lazovskis Inc. /ID# 61562
🇨🇦Sydney, Nova Scotia, Canada
Pavlova, Hamilton, CA /ID# 65011
🇨🇦Ancaster, Ontario, Canada
Waterside Clinique /ID# 72174
🇨🇦Barrie, Ontario, Canada
Brockville Medical Center /ID# 65502
🇨🇦Brockville, Ontario, Canada
Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347
🇨🇦Burlington, Ontario, Canada
Aviva Clinical Trial Group /ID# 54764
🇨🇦Burlington, Ontario, Canada
Dr. Chrisotomor Kouroukis & Dr /ID# 137831
🇨🇦Dundas, Ontario, Canada
Dr. William G. Bensen Centre /ID# 54762
🇨🇦Hamilton, Ontario, Canada
KW Musculoskeletal Research /ID# 70093
🇨🇦Kitchener, Ontario, Canada
Charlton Medical Centre /ID# 133072
🇨🇦Hamilton, Ontario, Canada
Charlton Medical Centre /ID# 55417
🇨🇦Hamilton, Ontario, Canada
West Mountain Medical Center /ID# 128877
🇨🇦Hamilton, Ontario, Canada
Brandusa Florica Med Prof Corp /ID# 81877
🇨🇦Mississauga, Ontario, Canada
Montgomery, Mississauga, CA /ID# 54581
🇨🇦Mississauga, Ontario, Canada
Rajwinder S. Dhillon Medicine /ID# 138671
🇨🇦Niagara Falls, Ontario, Canada
Imtiaz MS Khan Medicine Prof /ID# 55401
🇨🇦Mississauga, Ontario, Canada
Morassut, Nepean, Canada /ID# 55410
🇨🇦Nepean, Ontario, Canada
The Arthritis Program Res Grp /ID# 54755
🇨🇦Newmarket, Ontario, Canada
Kapur, Ottawa, Canada /ID# 55397
🇨🇦Ottawa, Ontario, Canada
Jonathan Stein Med Prof Corp /ID# 55451
🇨🇦Toronto, Ontario, Canada
Davis, Ottawa, CA /ID# 55296
🇨🇦Ottawa, Ontario, Canada
Hamilton, Toronto, CA /ID# 54575
🇨🇦Toronto, Ontario, Canada
Setty, Owen Sound, CA /ID# 54583
🇨🇦Owen Sound, Ontario, Canada
Niagara Peninsula Arthritis Ct /ID# 67282
🇨🇦St. Catharines, Ontario, Canada
Dr. Samuel K Silverberg /ID# 55449
🇨🇦Toronto, Ontario, Canada
Pedvis Med Prof Corp /ID# 55411
🇨🇦Toronto, Ontario, Canada
Ctr de Med Sportive de Laval /ID# 54576
🇨🇦Laval, Quebec, Canada
Institut de Rhum. de Montreal /ID# 54761
🇨🇦Montreal, Quebec, Canada
PSS Medical Inc. /ID# 54754
🇨🇦Montreal, Quebec, Canada
Couture, Outremont, CA /ID# 54574
🇨🇦Outremont, Quebec, Canada
Clinique Medicale Langelier /ID# 55460
🇨🇦Saint-leonard, Quebec, Canada
Ctr. de Rheum de l'est du QC /ID# 54765
🇨🇦Rimouski, Quebec, Canada
Groupe de Recherche en Maladies Osseuses /ID# 45623
🇨🇦Sainte-foy, Quebec, Canada
Rheum Disease Ctr of Montreal /ID# 143963
🇨🇦Westmount, Quebec, Canada
Ctr. de Recherche Musculo-Sque /ID# 55469
🇨🇦Trois-rivières, Quebec, Canada
Hudson, Kamloops, Canada /ID# 54577
🇨🇦Kamloops, British Columbia, Canada
Joshi, Brampton, Canada /ID# 54758
🇨🇦Brampton, Ontario, Canada