Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis
Complete-PsA
1 other identifier
observational
483
1 country
41
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2019
CompletedNovember 19, 2020
December 1, 2019
7.8 years
March 19, 2012
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Disease Activity Score - 28 (DAS-28)
The DAS - 28 is calculated using the number of swollen (SJC) and tender (TJC) joints out of 28, the erythrocyte sedimentation rate (ESR) and the patient's global assessment of disease activity using a 100 mm visual analogue scale (VAS)
Every 3 months up to 6 months, then every 6 months up to 24 months
Secondary Outcomes (5)
Duration of Morning Stiffness (min)
Every 3 months up to 6 months, then every 6 months up to 24 months
Dermatology Life Quality Index (DLQI)
Baseline, month 6, month12, month 24
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Every 3 months up to 6 months, then every 6 months up to 24 months
Patient Global Assessment of Disease Activity (VAS and 5 Point Scale)
Every 3 months up to 6 months, then every 6 months up to 24 months
Physician Global Assessment of Disease Activity (VAS and 5 Point Scale)
Every 3 months up to 6 months, then every 6 months up to 24 months
Study Arms (2)
adalimumab
Responding to treatment with non-biologic DMARDs (disease-modifying antirheumatic drugs) and initiated on treatment with adalimumab as monotherapy or in combination with other medications
DMARD (disease-modifying antirheumatic drugs)
Initiated on non-biologic DMARD(disease-modifying antirheumatic drugs) or requiring switching to another non biologic DMARD (disease-modifying antirheumatic drugs) as monotherapy, or in combination with other medications
Eligibility Criteria
Offices of community rheumatologists \& dermatologists
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVie (prior sponsor, Abbott)lead
- Cato Researchcollaborator
- JSS Medical Research Inc.collaborator
Study Sites (41)
Pont, Cranbrook, BC, CA /ID# 69120
Cranbrook, British Columbia, V1C 2R7, Canada
Dr. Barbara T. Blumenauer Inc. /ID# 75393
Kamloops, British Columbia, V2C 0B8, Canada
Hudson, Kamloops, Canada /ID# 69104
Kamloops, British Columbia, V2C 6G6, Canada
Dr. Maqbool R. Sheriff Inc. /ID# 69125
Nanaimo, British Columbia, V9S 4S1, Canada
Carmi Medical Clinic /ID# 69128
Penticton, British Columbia, V2A 3G7, Canada
Dr. J. Antonio Avina-Zubieta /ID# 71035
Richmond, British Columbia, V6X 2C7, Canada
Dr. Alfonso Verdejo Inc. /ID# 69131
Vancouver, British Columbia, V6Z 2E8, Canada
Dr. Milton F. Baker Inc. /ID# 69085
Victoria, British Columbia, V8P 5P6, Canada
Manitoba Clinic /ID# 69113
Winnipeg, Manitoba, R3A IM3, Canada
Nexus Clinical Research /ID# 45622
St. John's, Newfoundland and Labrador, A1B 5E8, Canada
St. Clare's Mercy Hospital /ID# 69121
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Qe Ii Hsc /Id# 69129
Halifax, Nova Scotia, B3H 1V7, Canada
Dr. Juris Lazovskis Inc. /ID# 69111
Sydney, Nova Scotia, B1S 3N1, Canada
Waterside Clinique /ID# 72173
Barrie, Ontario, L4M 6L2, Canada
Shickh, Bowmanville, Canada /ID# 90513
Bowmanville, Ontario, L1C 1P6, Canada
Brockville Medical Center /ID# 69105
Brockville, Ontario, K6V 5J9, Canada
Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092
Burlington, Ontario, L7L 0B7, Canada
Dr. Chrisotomor Kouroukis & Dr /ID# 137894
Dundas, Ontario, L9H 1B7, Canada
Charlton Medical Centre /ID# 133073
Hamilton, Ontario, L8N 1Y2, Canada
Charlton Medical Centre /ID# 69122
Hamilton, Ontario, L8N 1Y2, Canada
Dr. William G. Bensen Centre /ID# 69086
Hamilton, Ontario, L8N 1Y2, Canada
West Mountain Medical Center /ID# 128878
Hamilton, Ontario, L9C 5N2, Canada
Lynderm Research Inc. /ID# 76736
Markham, Ontario, L3P 1X2, Canada
Brandusa Florica Med Prof Corp /ID# 81876
Mississauga, Ontario, L5A 3V8, Canada
Credit Valley Rheumatology /ID# 69089
Mississauga, Ontario, L5M 2V8, Canada
Imtiaz MS Khan Medicine Prof /ID# 69110
Mississauga, Ontario, L5M 4N4, Canada
Rajwinder S. Dhillon Medicine /ID# 138672
Niagara Falls, Ontario, L2E 6A6, Canada
Davis, Ottawa, CA /ID# 69091
Ottawa, Ontario, K2P 1V3, Canada
Setty, Owen Sound, CA /ID# 69123
Owen Sound, Ontario, N4K 1S4, Canada
York Dermatology Clinic and Research Centre /ID# 127943
Richmond Hill, Ontario, L4C 9M7, Canada
Pedvis Med Prof Corp /ID# 69388
Toronto, Ontario, M4S 2C6, Canada
Jonathan Stein Med Prof Corp /ID# 71134
Toronto, Ontario, M6S 4W4, Canada
Karasik, Toronto, CA /ID# 69109
Toronto, Ontario, M9C 5N2, Canada
Institut de Rhum. de Montreal /ID# 69100
Montreal, Quebec, H2L 1S6, Canada
PSS Medical Inc. /ID# 69127
Montreal, Quebec, H3T 1Y3, Canada
Couture, Outremont, CA /ID# 69090
Outremont, Quebec, H2V 3Z5, Canada
Ctr. de Rheum de l'est du QC /ID# 69097
Rimouski, Quebec, G5L 8W1, Canada
Groupe de Recherche en Maladies Osseuses /ID# 69087
Sainte-Foy, Quebec, G1V 3M7, Canada
CHUS - Hopital Fleurimont /ID# 94735
Sherbrooke, Quebec, J1H 5N4, Canada
Ctr. de Recherche Musculo-Sque /ID# 69112
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Rheum Disease Ctr of Montreal /ID# 143964
Westmount, Quebec, H3Z 2Z3, Canada
Related Publications (1)
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.
PMID: 35033999DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 21, 2012
Study Start
February 16, 2012
Primary Completion
November 19, 2019
Study Completion
November 19, 2019
Last Updated
November 19, 2020
Record last verified: 2019-12