Clinical trial NCT01692912: Psoriatic Arthritis Treat to Target vs. Usual Care
Official title: A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psoriatic Arthritis (PsA)
Keywords: Psoriatic Arthritis
Randomized
Single blind
Treat to target
Lead sponsor: Pope Research Corporation
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2012-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients achieving low DAS
timeFrame: Month 9 Visit
Secondary outcomes:
measure: Time to achieving DAS28<2.6
timeFrame: Month 3 Visit, Month 6 Visit, and Month 9 Visit
measure: Absolute change in DAS28
timeFrame: Month 3 Visit, Month 6 Visit, Month 9 Visit
measure: Percentage of Patients achieving ACR 20, 50, and 70
timeFrame: Month 3 Visit, Month 6 Visit, Month 9 Visit
measure: Percentage of patients achieving PsARC
timeFrame: Month 3 Visit, Month 6 Visit, Month 9 Visit
measure: Absolute change in HAQ-DI
timeFrame: Month 3 Visit, Month 6 Visit, Month 9 Visit
Other outcomes:
Locations:
city: London
country: Canada
facility: Pope Research Corp., 68 Green Acres Drive
state: Ontario
city: Newmarket
country: Canada
facility: The Arthritis Program Research Group
state: Ontario
city: Toronto
country: Canada
facility: Arthur Karasik
state: Ontario
city: Montreal
country: Canada
facility: Institut de Rheumatologie de Montreal
state: Quebec
Study officials:
affiliation: Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London
name: Janet E. Pope, MD, MPH, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: