Psoriatic Arthritis Treat to Target vs. Usual Care (PRC-05-2011)
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|ClinicalTrials.gov Identifier: NCT01692912|
Recruitment Status : Withdrawn (no enrollment)
First Posted : September 25, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriatic Arthritis (PsA)||Other: Intensive Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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)
- Percentage of patients achieving low DAS [ Time Frame: 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.
- Time to achieving DAS28<2.6 [ Time Frame: 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 [ Time Frame: 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 ACR 20, 50, and 70 [ Time Frame: 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)
- ESR or CRP
- Percentage of patients achieving PsARC [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692912
|Pope Research Corp., 68 Green Acres Drive|
|London, Ontario, Canada, N6G 2S3|
|The Arthritis Program Research Group|
|Newmarket, Ontario, Canada|
|Toronto, Ontario, Canada, M9C 5N2|
|Institut de Rheumatologie de Montreal|
|Montreal, Quebec, Canada, H2L 1S6|
|Principal Investigator:||Janet E. Pope, MD, MPH, FRCPC||Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London|