An interventional study of Intensive Care in Psoriatic Arthritis (PsA), sponsored by Pope Research Corporation. Withdrawn at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Pope Research Corporation · Not applicable, Interventional, and Supportive care
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.
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
Browse Arthritis studies →Pope Research Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rheumatologists treating to target of DAS28\<2.6
Other: Intensive Care
Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28\<2.6)
Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28\<2.6
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
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.
Time frame: Month 3 Visit, Month 6 Visit, Month 9 Visit
This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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