Psoriatic Arthritis Treat to Target vs. Usual Care
- Conditions
- Psoriatic Arthritis (PsA)
- Registration Number
- NCT01692912
- Lead Sponsor
- Pope Research Corporation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients achieving low DAS Month 9 Visit 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients achieving ACR 20, 50, and 70 Month 3 Visit, Month 6 Visit, Month 9 Visit 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 CRPTime to achieving DAS28<2.6 Month 3 Visit, Month 6 Visit, and Month 9 Visit Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28\<2.6
Absolute change in DAS28 Month 3 Visit, Month 6 Visit, Month 9 Visit To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.
Percentage of patients achieving PsARC Month 3 Visit, Month 6 Visit, Month 9 Visit 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%.Absolute change in HAQ-DI Month 3 Visit, Month 6 Visit, Month 9 Visit 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.
Trial Locations
- 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
Pope Research Corp., 68 Green Acres Drive🇨🇦London, Ontario, Canada