Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)

Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA)

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).

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 483

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Cranbrook, British Columbia, Canada, V1C 2R7
      • Pont, Cranbrook, BC, CA /ID# 69120
    • Kamloops, British Columbia, Canada, V2C 0B8
      • Dr. Barbara T. Blumenauer Inc. /ID# 75393
    • Kamloops, British Columbia, Canada, V2C 6G6
      • Hudson, Kamloops, Canada /ID# 69104
    • Nanaimo, British Columbia, Canada, V9S 4S1
      • Dr. Maqbool R. Sheriff Inc. /ID# 69125
    • Penticton, British Columbia, Canada, V2A 3G7
      • Carmi Medical Clinic /ID# 69128
    • Richmond, British Columbia, Canada, V6X 2C7
      • Dr. J. Antonio Avina-Zubieta /ID# 71035
    • Vancouver, British Columbia, Canada, V6Z 2E8
      • Dr. Alfonso Verdejo Inc. /ID# 69131
    • Victoria, British Columbia, Canada, V8P 5P6
      • Dr. Milton F. Baker Inc. /ID# 69085
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A IM3
      • Manitoba Clinic /ID# 69113
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 5E8
      • Nexus Clinical Research /ID# 45622
    • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
      • St. Clare's Mercy Hospital /ID# 69121
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Qe Ii Hsc /Id# 69129
    • Sydney, Nova Scotia, Canada, B1S 3N1
      • Dr. Juris Lazovskis Inc. /ID# 69111
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Waterside Clinique /ID# 72173
    • Bowmanville, Ontario, Canada, L1C 1P6
      • Shickh, Bowmanville, Canada /ID# 90513
    • Brockville, Ontario, Canada, K6V 5J9
      • Brockville Medical Center /ID# 69105
    • Burlington, Ontario, Canada, L7L 0B7
      • Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092
    • Dundas, Ontario, Canada, L9H 1B7
      • Dr. Chrisotomor Kouroukis & Dr /ID# 137894
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Charlton Medical Centre /ID# 133073
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Charlton Medical Centre /ID# 69122
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dr. William G. Bensen Centre /ID# 69086
    • Hamilton, Ontario, Canada, L9C 5N2
      • West Mountain Medical Center /ID# 128878
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc. /ID# 76736
    • Mississauga, Ontario, Canada, L5A 3V8
      • Brandusa Florica Med Prof Corp /ID# 81876
    • Mississauga, Ontario, Canada, L5M 2V8
      • Credit Valley Rheumatology /ID# 69089
    • Mississauga, Ontario, Canada, L5M 4N4
      • Imtiaz MS Khan Medicine Prof /ID# 69110
    • Niagara Falls, Ontario, Canada, L2E 6A6
      • Rajwinder S. Dhillon Medicine /ID# 138672
    • Ottawa, Ontario, Canada, K2P 1V3
      • Davis, Ottawa, CA /ID# 69091
    • Owen Sound, Ontario, Canada, N4K 1S4
      • Setty, Owen Sound, CA /ID# 69123
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre /ID# 127943
    • Toronto, Ontario, Canada, M4S 2C6
      • Pedvis Med Prof Corp /ID# 69388
    • Toronto, Ontario, Canada, M6S 4W4
      • Jonathan Stein Med Prof Corp /ID# 71134
    • Toronto, Ontario, Canada, M9C 5N2
      • Karasik, Toronto, CA /ID# 69109
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rhum. de Montreal /ID# 69100
    • Montreal, Quebec, Canada, H3T 1Y3
      • PSS Medical Inc. /ID# 69127
    • Outremont, Quebec, Canada, H2V 3Z5
      • Couture, Outremont, CA /ID# 69090
    • Rimouski, Quebec, Canada, G5L 8W1
      • Ctr. de Rheum de l'est du QC /ID# 69097
    • Sainte-foy, Quebec, Canada, G1V 3M7
      • Groupe de Recherche en Maladies Osseuses /ID# 69087
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • CHUS - Hopital Fleurimont /ID# 94735
    • Trois-rivières, Quebec, Canada, G8Z 1Y2
      • Ctr. de Recherche Musculo-Sque /ID# 69112
    • Westmount, Quebec, Canada, H3Z 2Z3
      • Rheum Disease Ctr of Montreal /ID# 143964

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Offices of community rheumatologists & dermatologists

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Morning Stiffness (min)	This is ascertained by the treating physician during the patient assessment and is measured in minutes	Every 3 months up to 6 months, then every 6 months up to 24 months
Dermatology Life Quality Index (DLQI)	This is a self-administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease. The 10 questions in the DLQI converge into six domains that measure symptoms and feelings, daily activities, leisure, work and / or school, personal relationships and satisfaction with treatment.	Baseline, month 6, month12, month 24
Health Assessment Questionnaire - Disability Index (HAQ-DI)	Self-administered questionnaire measuring the patient's functional ability during the last week.	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)	A 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity and a five point Likert Scale (0 - 4) that is completed by the patient at the physician's office	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)	This is a 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity a five point Likert Scale (0 - 4) that is completed by the physician during the patient examination	Every 3 months up to 6 months, then every 6 months up to 24 months

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Cato Research; JSS Medical Research Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info
• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2012
• Primary Completion (ACTUAL): November 19, 2019
• Study Completion (ACTUAL): November 19, 2019

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 19, 2012
• First Posted (ESTIMATE): March 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Assessing Effectiveness in Psoriatic Arthritis
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: P12-666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No