Canadian Humira Post Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— Complete-PsA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559038
• Other study ID #: P12-666
• Status: Completed
• Start date: February 16, 2012
• Est. completion date: November 19, 2019

Study information

• Verified date: December 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
Canada	Waterside Clinique /ID# 72173	Barrie	Ontario
Canada	Shickh, Bowmanville, Canada /ID# 90513	Bowmanville	Ontario
Canada	Brockville Medical Center /ID# 69105	Brockville	Ontario
Canada	Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092	Burlington	Ontario
Canada	Pont, Cranbrook, BC, CA /ID# 69120	Cranbrook	British Columbia
Canada	Dr. Chrisotomor Kouroukis & Dr /ID# 137894	Dundas	Ontario
Canada	Qe Ii Hsc /Id# 69129	Halifax	Nova Scotia
Canada	Charlton Medical Centre /ID# 133073	Hamilton	Ontario
Canada	Charlton Medical Centre /ID# 69122	Hamilton	Ontario
Canada	Dr. William G. Bensen Centre /ID# 69086	Hamilton	Ontario
Canada	West Mountain Medical Center /ID# 128878	Hamilton	Ontario
Canada	Dr. Barbara T. Blumenauer Inc. /ID# 75393	Kamloops	British Columbia
Canada	Hudson, Kamloops, Canada /ID# 69104	Kamloops	British Columbia
Canada	Lynderm Research Inc. /ID# 76736	Markham	Ontario
Canada	Brandusa Florica Med Prof Corp /ID# 81876	Mississauga	Ontario
Canada	Credit Valley Rheumatology /ID# 69089	Mississauga	Ontario
Canada	Imtiaz MS Khan Medicine Prof /ID# 69110	Mississauga	Ontario
Canada	Institut de Rhum. de Montreal /ID# 69100	Montreal	Quebec
Canada	PSS Medical Inc. /ID# 69127	Montreal	Quebec
Canada	Dr. Maqbool R. Sheriff Inc. /ID# 69125	Nanaimo	British Columbia
Canada	Rajwinder S. Dhillon Medicine /ID# 138672	Niagara Falls	Ontario
Canada	Davis, Ottawa, CA /ID# 69091	Ottawa	Ontario
Canada	Couture, Outremont, CA /ID# 69090	Outremont	Quebec
Canada	Setty, Owen Sound, CA /ID# 69123	Owen Sound	Ontario
Canada	Carmi Medical Clinic /ID# 69128	Penticton	British Columbia
Canada	Dr. J. Antonio Avina-Zubieta /ID# 71035	Richmond	British Columbia
Canada	York Dermatology Clinic and Research Centre /ID# 127943	Richmond Hill	Ontario
Canada	Ctr. de Rheum de l'est du QC /ID# 69097	Rimouski	Quebec
Canada	Groupe de Recherche en Maladies Osseuses /ID# 69087	Sainte-foy	Quebec
Canada	CHUS - Hopital Fleurimont /ID# 94735	Sherbrooke	Quebec
Canada	Nexus Clinical Research /ID# 45622	St. John's	Newfoundland and Labrador
Canada	St. Clare's Mercy Hospital /ID# 69121	St. John's	Newfoundland and Labrador
Canada	Dr. Juris Lazovskis Inc. /ID# 69111	Sydney	Nova Scotia
Canada	Jonathan Stein Med Prof Corp /ID# 71134	Toronto	Ontario
Canada	Karasik, Toronto, CA /ID# 69109	Toronto	Ontario
Canada	Pedvis Med Prof Corp /ID# 69388	Toronto	Ontario
Canada	Ctr. de Recherche Musculo-Sque /ID# 69112	Trois-rivières	Quebec
Canada	Dr. Alfonso Verdejo Inc. /ID# 69131	Vancouver	British Columbia
Canada	Dr. Milton F. Baker Inc. /ID# 69085	Victoria	British Columbia
Canada	Rheum Disease Ctr of Montreal /ID# 143964	Westmount	Quebec
Canada	Manitoba Clinic /ID# 69113	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Cato Research, JSS Medical Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis
•   Related Info