Psoriatic Arthritis Treat to Target vs. Usual Care

Study Overview
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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.

Official Title
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A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care

Conditions
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Psoriatic Arthritis (PsA)

Intervention / Treatment
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* Other: Intensive Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive Care (IC)<br>Rheumatologists treating to target of DAS28<2.6 | Other: Intensive Care<br>* Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6<br>|
| No Intervention: Routine Care (RC)<br>Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 9 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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%. | 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. | Month 3 Visit, Month 6 Visit, Month 9 Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Single blind, Treat to target, Randomized