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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on October 29, 2014