Psoriatic Arthritis Treat to Target vs. Usual Care (PRC-05-2011)
Primary Purpose
Psoriatic Arthritis (PsA)
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intensive Care
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriatic Arthritis (PsA) focused on measuring Psoriatic Arthritis, Randomized, Single blind, Treat to target
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
Sites / Locations
- Pope Research Corp., 68 Green Acres Drive
- The Arthritis Program Research Group
- Arthur Karasik
- Institut de Rheumatologie de Montreal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intensive Care (IC)
Routine Care (RC)
Arm Description
Rheumatologists treating to target of DAS28<2.6
Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Absolute change in DAS28
To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.
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
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%.
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.
Full Information
NCT ID
NCT01692912
First Posted
September 21, 2012
Last Updated
April 5, 2017
Sponsor
Pope Research Corporation
Collaborators
Amgen
1. Study Identification
Unique Protocol Identification Number
NCT01692912
Brief Title
Psoriatic Arthritis Treat to Target vs. Usual Care
Acronym
PRC-05-2011
Official Title
A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pope Research Corporation
Collaborators
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis (PsA)
Keywords
Psoriatic Arthritis, Randomized, Single blind, Treat to target
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Care (IC)
Arm Type
Active Comparator
Arm Description
Rheumatologists treating to target of DAS28<2.6
Arm Title
Routine Care (RC)
Arm Type
No Intervention
Arm Description
Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6)
Intervention Type
Other
Intervention Name(s)
Intensive Care
Intervention Description
Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6
Primary Outcome Measure Information:
Title
Percentage of patients achieving low DAS
Description
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 Frame
Month 9 Visit
Secondary Outcome Measure Information:
Title
Time to achieving DAS28<2.6
Description
Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28<2.6
Time Frame
Month 3 Visit, Month 6 Visit, and Month 9 Visit
Title
Absolute change in DAS28
Description
To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.
Time Frame
Month 3 Visit, Month 6 Visit, Month 9 Visit
Title
Percentage of Patients achieving ACR 20, 50, and 70
Description
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
Time Frame
Month 3 Visit, Month 6 Visit, Month 9 Visit
Title
Percentage of patients achieving PsARC
Description
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%.
Time Frame
Month 3 Visit, Month 6 Visit, Month 9 Visit
Title
Absolute change in HAQ-DI
Description
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.
Time Frame
Month 3 Visit, Month 6 Visit, Month 9 Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet E. Pope, MD, MPH, FRCPC
Organizational Affiliation
Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pope Research Corp., 68 Green Acres Drive
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2S3
Country
Canada
Facility Name
The Arthritis Program Research Group
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Arthur Karasik
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9C 5N2
Country
Canada
Facility Name
Institut de Rheumatologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Psoriatic Arthritis Treat to Target vs. Usual Care
We'll reach out to this number within 24 hrs