Clinical trial NCT01387802: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis
Official title: Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis (Complete - AS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Assessing Effectiveness in Ankylosing Spondylitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
name: Cato Research
First posted: 2011-07-06
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Offices of community rheumatologists

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.


Eligibility 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

Primary outcomes:
measure: Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Uveitis
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Psoriasis
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Inflammatory Bowel Disease
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Occurrence, flare-up or exacerbation of Extra Articular Manifestations in Enthesitis of the Heel: Achilles Tendon and Plantar Fascia
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
Secondary outcomes:
measure: BASFI (Bath AS Functional Assay)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: PASQ (Psoriasis and Arthritis Screening Questionnaire)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: BASDAI (Bath AS Disease Activity Index)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rheumatology Clinic /ID# 54768
state: Alberta
city: Calgary
country: Canada
facility: Associate Clinic /ID# 64274
state: Alberta
city: Cranbrook
country: Canada
facility: Pont, Cranbrook, BC, CA /ID# 55242
state: British Columbia
city: Kamloops
country: Canada
facility: Dr. Barbara T. Blumenauer Inc. /ID# 55226
state: British Columbia
city: Kamloops
country: Canada
facility: Hudson, Kamloops, Canada /ID# 54577
state: British Columbia
city: Nanaimo
country: Canada
facility: Dr. Maqbool R. Sheriff Inc. /ID# 55247
state: British Columbia
city: Penticton
country: Canada
facility: Stewart, Penticton, CA /ID# 67096
state: British Columbia
city: Prince George
country: Canada
facility: Dr. Michael Buchanan, Inc. /ID# 55227
state: British Columbia
city: Richmond
country: Canada
facility: Dr. J. Antonio Avina-Zubieta /ID# 68263
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Alfonso Verdejo Inc. /ID# 54572
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Milton F. Baker Inc. /ID# 55197
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 54580
state: Manitoba
city: Fredericton
country: Canada
facility: Bulleid Henderson Prof. Corp. /ID# 55256
state: New Brunswick
city: Fredericton
country: Canada
facility: Ecker, Fredericton, CA /ID# 54748
state: New Brunswick
city: St. John's
country: Canada
facility: Nexus Clinical Research /ID# 54757
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital /ID# 54767
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 55261
state: Nova Scotia
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc. /ID# 61562
state: Nova Scotia
city: Ancaster
country: Canada
facility: Pavlova, Hamilton, CA /ID# 65011
state: Ontario
city: Barrie
country: Canada
facility: Waterside Clinique /ID# 72174
state: Ontario
city: Brampton
country: Canada
facility: Joshi, Brampton, Canada /ID# 54758
state: Ontario
city: Brockville
country: Canada
facility: Brockville Medical Center /ID# 65502
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sanjay Dixit Medicine Professional Corporation /ID# 67347
state: Ontario
city: Burlington
country: Canada
facility: Aviva Clinical Trial Group /ID# 54764
state: Ontario
city: Dundas
country: Canada
facility: Dr. Chrisotomor Kouroukis & Dr /ID# 137831
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Centre /ID# 133072
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Centre /ID# 55417
state: Ontario
city: Hamilton
country: Canada
facility: Dr. William G. Bensen Centre /ID# 54762
state: Ontario
city: Hamilton
country: Canada
facility: West Mountain Medical Center /ID# 128877
state: Ontario
city: Kitchener
country: Canada
facility: KW Musculoskeletal Research /ID# 70093
state: Ontario
city: Mississauga
country: Canada
facility: Brandusa Florica Med Prof Corp /ID# 81877
state: Ontario
city: Mississauga
country: Canada
facility: Montgomery, Mississauga, CA /ID# 54581
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 54750
state: Ontario
city: Mississauga
country: Canada
facility: Imtiaz MS Khan Medicine Prof /ID# 55401
state: Ontario
city: Nepean
country: Canada
facility: Morassut, Nepean, Canada /ID# 55410
state: Ontario
city: Newmarket
country: Canada
facility: The Arthritis Program Res Grp /ID# 54755
state: Ontario
city: Niagara Falls
country: Canada
facility: Rajwinder S. Dhillon Medicine /ID# 138671
state: Ontario
city: Ottawa
country: Canada
facility: Kapur, Ottawa, Canada /ID# 55397
state: Ontario
city: Ottawa
country: Canada
facility: Davis, Ottawa, CA /ID# 55296
state: Ontario
city: Owen Sound
country: Canada
facility: Setty, Owen Sound, CA /ID# 54583
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Peninsula Arthritis Ct /ID# 67282
state: Ontario
city: Toronto
country: Canada
facility: Pedvis Med Prof Corp /ID# 55411
state: Ontario
city: Toronto
country: Canada
facility: Hamilton, Toronto, CA /ID# 54575
state: Ontario
city: Toronto
country: Canada
facility: Jonathan Stein Med Prof Corp /ID# 55451
state: Ontario
city: Toronto
country: Canada
facility: Karasik, Toronto, CA /ID# 54751
state: Ontario
city: Toronto
country: Canada
facility: Dr. Samuel K Silverberg /ID# 55449
state: Ontario
city: Laval
country: Canada
facility: Ctr de Med Sportive de Laval /ID# 54576
state: Quebec
city: Montreal
country: Canada
facility: Institut de Rhum. de Montreal /ID# 54761
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 63655
state: Quebec
city: Montreal
country: Canada
facility: PSS Medical Inc. /ID# 54754
state: Quebec
city: Outremont
country: Canada
facility: Couture, Outremont, CA /ID# 54574
state: Quebec
city: Rimouski
country: Canada
facility: Ctr. de Rheum de l'est du QC /ID# 54765
state: Quebec
city: Saint-leonard
country: Canada
facility: Clinique Medicale Langelier /ID# 55460
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses /ID# 45623
state: Quebec
city: Trois-rivières
country: Canada
facility: Ctr. de Recherche Musculo-Sque /ID# 55469
state: Quebec
city: Westmount
country: Canada
facility: Rheum Disease Ctr of Montreal /ID# 143963
state: Quebec
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: