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

NCT ID: NCT01559038

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-16

Study Completion Date

2019-11-19

Brief Summary

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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).

Detailed Description

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Conditions

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Psoriatic Arthritis

Keywords

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Assessing Effectiveness in Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cato Research

INDUSTRY

Sponsor Role collaborator

JSS Medical Research Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Pont, Cranbrook, BC, CA /ID# 69120

Cranbrook, British Columbia, Canada

Site Status

Dr. Barbara T. Blumenauer Inc. /ID# 75393

Kamloops, British Columbia, Canada

Site Status

Hudson, Kamloops, Canada /ID# 69104

Kamloops, British Columbia, Canada

Site Status

Dr. Maqbool R. Sheriff Inc. /ID# 69125

Nanaimo, British Columbia, Canada

Site Status

Carmi Medical Clinic /ID# 69128

Penticton, British Columbia, Canada

Site Status

Dr. J. Antonio Avina-Zubieta /ID# 71035

Richmond, British Columbia, Canada

Site Status

Dr. Alfonso Verdejo Inc. /ID# 69131

Vancouver, British Columbia, Canada

Site Status

Dr. Milton F. Baker Inc. /ID# 69085

Victoria, British Columbia, Canada

Site Status

Manitoba Clinic /ID# 69113

Winnipeg, Manitoba, Canada

Site Status

Nexus Clinical Research /ID# 45622

St. John's, Newfoundland and Labrador, Canada

Site Status

St. Clare's Mercy Hospital /ID# 69121

St. John's, Newfoundland and Labrador, Canada

Site Status

Qe Ii Hsc /Id# 69129

Halifax, Nova Scotia, Canada

Site Status

Dr. Juris Lazovskis Inc. /ID# 69111

Sydney, Nova Scotia, Canada

Site Status

Waterside Clinique /ID# 72173

Barrie, Ontario, Canada

Site Status

Shickh, Bowmanville, Canada /ID# 90513

Bowmanville, Ontario, Canada

Site Status

Brockville Medical Center /ID# 69105

Brockville, Ontario, Canada

Site Status

Dr. Sanjay Dixit Medicine Professional Corporation /ID# 69092

Burlington, Ontario, Canada

Site Status

Dr. Chrisotomor Kouroukis & Dr /ID# 137894

Dundas, Ontario, Canada

Site Status

Charlton Medical Centre /ID# 133073

Hamilton, Ontario, Canada

Site Status

Charlton Medical Centre /ID# 69122

Hamilton, Ontario, Canada

Site Status

Dr. William G. Bensen Centre /ID# 69086

Hamilton, Ontario, Canada

Site Status

West Mountain Medical Center /ID# 128878

Hamilton, Ontario, Canada

Site Status

Lynderm Research Inc. /ID# 76736

Markham, Ontario, Canada

Site Status

Brandusa Florica Med Prof Corp /ID# 81876

Mississauga, Ontario, Canada

Site Status

Credit Valley Rheumatology /ID# 69089

Mississauga, Ontario, Canada

Site Status

Imtiaz MS Khan Medicine Prof /ID# 69110

Mississauga, Ontario, Canada

Site Status

Rajwinder S. Dhillon Medicine /ID# 138672

Niagara Falls, Ontario, Canada

Site Status

Davis, Ottawa, CA /ID# 69091

Ottawa, Ontario, Canada

Site Status

Setty, Owen Sound, CA /ID# 69123

Owen Sound, Ontario, Canada

Site Status

York Dermatology Clinic and Research Centre /ID# 127943

Richmond Hill, Ontario, Canada

Site Status

Pedvis Med Prof Corp /ID# 69388

Toronto, Ontario, Canada

Site Status

Jonathan Stein Med Prof Corp /ID# 71134

Toronto, Ontario, Canada

Site Status

Karasik, Toronto, CA /ID# 69109

Toronto, Ontario, Canada

Site Status

Institut de Rhum. de Montreal /ID# 69100

Montreal, Quebec, Canada

Site Status

PSS Medical Inc. /ID# 69127

Montreal, Quebec, Canada

Site Status

Couture, Outremont, CA /ID# 69090

Outremont, Quebec, Canada

Site Status

Ctr. de Rheum de l'est du QC /ID# 69097

Rimouski, Quebec, Canada

Site Status

Groupe de Recherche en Maladies Osseuses /ID# 69087

Sainte-Foy, Quebec, Canada

Site Status

CHUS - Hopital Fleurimont /ID# 94735

Sherbrooke, Quebec, Canada

Site Status

Ctr. de Recherche Musculo-Sque /ID# 69112

Trois-Rivières, Quebec, Canada

Site Status

Rheum Disease Ctr of Montreal /ID# 143964

Westmount, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35033999 (View on PubMed)

Related Links

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Other Identifiers

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P12-666

Identifier Type: -

Identifier Source: org_study_id