Psoriatic Arthritis Treat to Target vs. Usual Care

Pope Research Corporation

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Conditions

Psoriatic Arthritis (PsA)

Interventions

Intensive CareOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Pope Research Corp., 68 Green Acres Drive

London, Ontario, Canada

The Arthritis Program Research Group

Newmarket, Ontario, Canada

Arthur Karasik

Toronto, Ontario, Canada

Institut de Rheumatologie de Montreal

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Percentage of patients achieving low DAS

The primary outcome measure will be the percentage of patients achieving low Disease Activity Score (DAS\<2.6) in each patient group (Intensive Care vs. Routine Care) at the end of the study.

Time frame: Month 9 Visit

Secondary Outcomes

Time to achieving DAS28<2.6

Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28\<2.6

Time frame: Month 3 Visit, Month 6 Visit, and Month 9 Visit

Absolute change in DAS28

To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.

Time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit

Percentage of Patients achieving ACR 20, 50, and 70

ACR 20/50/70 defined as: * 20%, 50%, or 70% reduction in tender joint count, and * 20%, 50%, or 70% reduction in swollen joint count, and * a 20%, 50%, or 70% reduction in 3 of the following 5 measures: * Patient and physician global assessments (VAS) * Patient pain score (VAS) * HAQ-DI * ESR or CRP

Time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit

Percentage of patients achieving PsARC

PsARC defined as improvement in at least 2 of the 4 following measures, one of which must be joint swelling or tenderness, and no worsening in any of the 4 measures: * MDGA (0-5 point scale): reduction by 1 point. * PGA (0-5 point scale): reduction by 1 point. * TJC (76 or 68): reduction by \>=30%. * SJC (76 or 68): reduction by \>=30%.

Time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit

Absolute change in HAQ-DI

HAQ-DI is a self-administered questionnaire using the patient's functional ability during the last week. It consists of 20 items converging to 8 scales measuring dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The patients rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 4 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability.

Data from ClinicalTrials.gov

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