Psoriatic Arthritis Treat to Target vs. Usual Care

NCT ID: NCT01692912

Last Updated: 2017-04-07

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score \<2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.

Detailed Description

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Canadian Rheumatologists will be randomized to treat their participants with active Psoriatic Arthritis to a target (disease activity score \<2.6), or as per their routine care. The aim of this study is to determine whether treating to a target results in greater disease improvement than treating patients using routine care.

Conditions

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Psoriatic Arthritis (PsA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intensive Care (IC)

Rheumatologists treating to target of DAS28\<2.6

Group Type ACTIVE_COMPARATOR

Intensive Care

Intervention Type OTHER

Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28\<2.6

Routine Care (RC)

Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28\<2.6)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Care

Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28\<2.6

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Psoriatic Arthritis as diagnosed by a rheumatologist and meeting ACR classification criteria for PsA or CASPAR criteria
* The subject must provide written informed consent for participation in the study before any study specific procedures are performed
* Subject has 3 or more SJC on 28 joint count
* Age \>=18

Exclusion Criteria

* Subject has a history of being non-compliant
* Serious concomitant illnesses that in the investigator's opinion negate ability to optimally treat the patient
* If treating with TNF inhibitor, positive PPD \> 5mm who have not received INH for recommended course or untreated TB (ie CXR evidence of latent infection). Usual screening is in place for standard of care.
* Pregnancy, breast-feeding or considering pregnancy over the next 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Pope Research Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet E. Pope, MD, MPH, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London

Locations

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Pope Research Corp., 68 Green Acres Drive

London, Ontario, Canada

Site Status

The Arthritis Program Research Group

Newmarket, Ontario, Canada

Site Status

Arthur Karasik

Toronto, Ontario, Canada

Site Status

Institut de Rheumatologie de Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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PRC-05-2011

Identifier Type: -

Identifier Source: org_study_id

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