Psoriatic Arthritis Treat to Target vs. Usual Care (PRC-05-2011)
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care|
- Percentage of patients achieving low DAS [ Time Frame: Month 9 Visit ] [ Designated as safety issue: No ]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 to achieving DAS28<2.6 [ Time Frame: Month 3 Visit, Month 6 Visit, and Month 9 Visit ] [ Designated as safety issue: No ]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 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.
- Percentage of Patients achieving ACR 20, 50, and 70 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]
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)
- ESR or CRP
- Percentage of patients achieving PsARC [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]
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 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Intensive Care (IC)
Rheumatologists treating to target of DAS28<2.6
Other: Intensive Care
Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6
No Intervention: Routine Care (RC)
Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692912
|Contact: Janet E. Pope, MD, MPH, FRCPC||1-519-619-7317||Janet.Pope@sjhc.london.on.ca|
|Pope Research Corp., 68 Green Acres Drive||Not yet recruiting|
|London, Ontario, Canada, N6G 2S3|
|Contact: Janet E. Pope, MD, MPH, FRCPC 1-519-619-7317 Janet.Pope@sjhc.london.on.ca|
|The Arthritis Program Research Group||Recruiting|
|Newmarket, Ontario, Canada|
|Principal Investigator: Carter Thorne, MD|
|Toronto, Ontario, Canada, M9C 5N2|
|Principal Investigator: Arthur Karasik, MD, FRCPC|
|Institut de Rheumatologie de Montreal||Recruiting|
|Montreal, Quebec, Canada, H2L 1S6|
|Principal Investigator: Boulos Haraoui, MD|
|Principal Investigator:||Janet E. Pope, MD, MPH, FRCPC||Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London|