Clinical trial NCT01559038: Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis
Official title: Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Assessing Effectiveness in Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
name: JSS Medical Research Inc.
First posted: 2012-03-21
Enrollment: 483
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 \& dermatologists

Brief summary: The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).


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 Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis
* Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA

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-tumor necrosis factor (anti-TNF) or other biologic agent

Primary outcomes:
measure: Change in the Disease Activity Score - 28 (DAS-28)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
Secondary outcomes:
measure: Duration of Morning Stiffness (min)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, month 6, month12, month 24
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Patient Global Assessment of Disease Activity (VAS and 5 Point Scale)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
measure: Physician Global Assessment of Disease Activity (VAS and 5 Point Scale)
timeFrame: Every 3 months up to 6 months, then every 6 months up to 24 months
Other outcomes:
Locations:
city: Cranbrook
country: Canada
facility: Pont, Cranbrook, BC, CA /ID# 69120
state: British Columbia
city: Kamloops
country: Canada
facility: Dr. Barbara T. Blumenauer Inc. /ID# 75393
state: British Columbia
city: Kamloops
country: Canada
facility: Hudson, Kamloops, Canada /ID# 69104
state: British Columbia
city: Nanaimo
country: Canada
facility: Dr. Maqbool R. Sheriff Inc. /ID# 69125
state: British Columbia
city: Penticton
country: Canada
facility: Carmi Medical Clinic /ID# 69128
state: British Columbia
city: Richmond
country: Canada
facility: Dr. J. Antonio Avina-Zubieta /ID# 71035
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Alfonso Verdejo Inc. /ID# 69131
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Milton F. Baker Inc. /ID# 69085
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 69113
state: Manitoba
city: St. John's
country: Canada
facility: Nexus Clinical Research /ID# 45622
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital /ID# 69121
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 69129
state: Nova Scotia
city: Sydney
country: Canada
facility: Dr. Juris Lazovskis Inc. /ID# 69111
state: Nova Scotia
city: Barrie
country: Canada
facility: Waterside Clinique /ID# 72173
state: Ontario
city: Bowmanville
country: Canada
facility: Shickh, Bowmanville, Canada /ID# 90513
state: Ontario
city: Brockville
country: Canada
facility: Brockville Medical Center /ID# 69105
state: Ontario
city: Burlington
country: Canada
facility: Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092
state: Ontario
city: Dundas
country: Canada
facility: Dr. Chrisotomor Kouroukis & Dr /ID# 137894
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Centre /ID# 133073
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Centre /ID# 69122
state: Ontario
city: Hamilton
country: Canada
facility: Dr. William G. Bensen Centre /ID# 69086
state: Ontario
city: Hamilton
country: Canada
facility: West Mountain Medical Center /ID# 128878
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc. /ID# 76736
state: Ontario
city: Mississauga
country: Canada
facility: Brandusa Florica Med Prof Corp /ID# 81876
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology /ID# 69089
state: Ontario
city: Mississauga
country: Canada
facility: Imtiaz MS Khan Medicine Prof /ID# 69110
state: Ontario
city: Niagara Falls
country: Canada
facility: Rajwinder S. Dhillon Medicine /ID# 138672
state: Ontario
city: Ottawa
country: Canada
facility: Davis, Ottawa, CA /ID# 69091
state: Ontario
city: Owen Sound
country: Canada
facility: Setty, Owen Sound, CA /ID# 69123
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre /ID# 127943
state: Ontario
city: Toronto
country: Canada
facility: Pedvis Med Prof Corp /ID# 69388
state: Ontario
city: Toronto
country: Canada
facility: Jonathan Stein Med Prof Corp /ID# 71134
state: Ontario
city: Toronto
country: Canada
facility: Karasik, Toronto, CA /ID# 69109
state: Ontario
city: Montreal
country: Canada
facility: Institut de Rhum. de Montreal /ID# 69100
state: Quebec
city: Montreal
country: Canada
facility: PSS Medical Inc. /ID# 69127
state: Quebec
city: Outremont
country: Canada
facility: Couture, Outremont, CA /ID# 69090
state: Quebec
city: Rimouski
country: Canada
facility: Ctr. de Rheum de l'est du QC /ID# 69097
state: Quebec
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses /ID# 69087
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 94735
state: Quebec
city: Trois-rivières
country: Canada
facility: Ctr. de Recherche Musculo-Sque /ID# 69112
state: Quebec
city: Westmount
country: Canada
facility: Rheum Disease Ctr of Montreal /ID# 143964
state: Quebec
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Khraishi MM, Remple VP, Silverberg S, Stewart JC, Florica B, Bessette L. Canadian Adalimumab Postmarketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-month Results of Comparative Effectiveness of Adalimumab and nbDMARDs. J Rheumatol. 2022 May;49(5):454-464. doi: 10.3899/jrheum.200609. Epub 2022 Jan 15.