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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Withdrawn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
Pope Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 21, 2012
Last Updated
April 5, 2017
Sponsor
Pope Research Corporation
Collaborators
Amgen
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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

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Psoriatic Arthritis Treat to Target vs. Usual Care

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