Psoriatic Arthritis Treat to Target vs. Usual Care (PRC-05-2011)

A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual 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.

Study Overview

• Status: Withdrawn
• Conditions: Psoriatic Arthritis (PsA)
• Intervention / Treatment: Other: Intensive 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 2S3
      • Pope Research Corp., 68 Green Acres Drive
    • Newmarket, Ontario, Canada
      • The Arthritis Program Research Group
    • Toronto, Ontario, Canada, M9C 5N2
      • Arthur Karasik
  • Quebec
    • Montreal, Quebec, Canada, H2L 1S6
      • Institut de Rheumatologie de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: 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	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: 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%.	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

Collaborators and Investigators

• Sponsor: Pope Research Corporation
• Collaborators: Amgen
• Investigators: Principal Investigator: Janet E. Pope, MD, MPH, FRCPC, Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 21, 2012
• First Posted (ESTIMATE): September 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; Randomized; Single blind; Treat to target
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: PRC-05-2011