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

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ClinicalTrials.gov Identifier: NCT01692912
Recruitment Status : Withdrawn (no enrollment)
First Posted : September 25, 2012
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Pope Research Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis (PsA) Other: Intensive Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients achieving low DAS [ Time Frame: Month 9 Visit ]
    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 :
  1. Time to achieving DAS28<2.6 [ Time Frame: Month 3 Visit, Month 6 Visit, and Month 9 Visit ]
    Compares the effectiveness of Intensive Care and Routine Care groups, as measured by the time to achieving target of DAS28<2.6

  2. Absolute change in DAS28 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ]
    To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.

  3. Percentage of Patients achieving ACR 20, 50, and 70 [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ]

    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

  4. Percentage of patients achieving PsARC [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ]

    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%.

  5. Absolute change in HAQ-DI [ Time Frame: Month 3 Visit, Month 6 Visit, Month 9 Visit ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692912


Locations
Canada, Ontario
Pope Research Corp., 68 Green Acres Drive
London, Ontario, Canada, N6G 2S3
The Arthritis Program Research Group
Newmarket, Ontario, Canada
Arthur Karasik
Toronto, Ontario, Canada, M9C 5N2
Canada, Quebec
Institut de Rheumatologie de Montreal
Montreal, Quebec, Canada, H2L 1S6
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
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Responsible Party: Pope Research Corporation
ClinicalTrials.gov Identifier: NCT01692912     History of Changes
Other Study ID Numbers: PRC-05-2011
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

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

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