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

This study is currently recruiting participants.
Verified November 2013 by Pope Research Corporation
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Pope Research Corporation
ClinicalTrials.gov Identifier:
NCT01692912
First received: September 21, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Psoriatic Arthritis (PsA)
Other: Intensive Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care

Resource links provided by NLM:


Further study details as provided by Pope Research Corporation:

Primary Outcome Measures:
  • Percentage of patients achieving low DAS [ Time Frame: Month 9 Visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 3 Visit, Month 6 Visit, and Month 9 Visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]
    To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.

  • Percentage of Patients achieving ACR 20, 50, and 70 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]

    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 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]

    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 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 230
Study Start Date: October 2012
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692912

Contacts
Contact: Janet E. Pope, MD, MPH, FRCPC 1-519-619-7317 Janet.Pope@sjhc.london.on.ca

Locations
Canada, Ontario
Pope Research Corp., 68 Green Acres Drive Not yet recruiting
London, Ontario, Canada, N6G 2S3
Contact: Janet E. Pope, MD, MPH, FRCPC    1-519-619-7317    Janet.Pope@sjhc.london.on.ca   
The Arthritis Program Research Group Recruiting
Newmarket, Ontario, Canada
Principal Investigator: Carter Thorne, MD         
Arthur Karasik Recruiting
Toronto, Ontario, Canada, M9C 5N2
Principal Investigator: Arthur Karasik, MD, FRCPC         
Canada, Quebec
Institut de Rheumatologie de Montreal Recruiting
Montreal, Quebec, Canada, H2L 1S6
Principal Investigator: Boulos Haraoui, MD         
Sponsors and Collaborators
Pope Research Corporation
Amgen
Investigators
Principal Investigator: Janet E. Pope, MD, MPH, FRCPC Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London
  More Information

No publications provided

Responsible Party: Pope Research Corporation
ClinicalTrials.gov Identifier: NCT01692912     History of Changes
Other Study ID Numbers: PRC-05-2011
Study First Received: September 21, 2012
Last Updated: November 13, 2013
Health Authority: Canada: Health Canada

Keywords provided by Pope Research Corporation:
Psoriatic Arthritis
Randomized
Single blind
Treat to target

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 20, 2014