Psoriatic Arthritis (PsA)
Conditions
Keywords
Psoriatic Arthritis, Randomized, Single blind, Treat to target
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.
Interventions
OTHERIntensive Care
Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28\<2.6
Sponsors
Amgen
Pope Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time 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 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 CRP |
| 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. |
Countries
Canada
Outcome results
None listed