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no enrollment
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Care (IC) | Active Comparator | Rheumatologists treating to target of DAS28<2.6 |
|
| Routine Care (RC) | No Intervention | Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Care | Other | Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet E. Pope, MD, MPH, FRCPC | Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pope Research Corp., 68 Green Acres Drive | London | Ontario | N6G 2S3 | Canada | ||
| The Arthritis Program Research Group |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D003422 | Critical Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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:
| 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:
| 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 |
| Newmarket |
| Ontario |
| Canada |
| Arthur Karasik | Toronto | Ontario | M9C 5N2 | Canada |
| Institut de Rheumatologie de Montreal | Montreal | Quebec | H2L 1S6 | Canada |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |