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Psoriatic Arthritis (PsA)PRC-05-2011NCT01692912

Psoriatic Arthritis Treat to Target vs. Usual Care

A study testing Intensive Care in people with Psoriatic Arthritis (PsA), run by Pope Research Corporation at 4 sites in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis (PsA)
What is being tested?
Intensive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesCanada
Study dates
Oct 2012to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Pope Research Corp., 68 Green Acres Drive

    London, Ontario, N6G 2S3

  • Institut de Rheumatologie de Montreal

    Montreal, Quebec, H2L 1S6

  • The Arthritis Program Research Group

    Newmarket, Ontario

  • Arthur Karasik

    Toronto, Ontario, M9C 5N2

Other trials in Canada

About this study

Official title: A Trial of Active Psoriatic Arthritis (PsA): Randomizing to Treat to a Target vs. Usual Care

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.

Read the 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.

Being tested
Intensive Care
Keywords
Psoriatic Arthritis, Randomized, Single blind, Treat to target
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive CareOther

    Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6

Study groups in NCT01692912
Study groupRoleWhat they receive
Intensive Care (IC)Active comparatorRheumatologists treating to target of DAS28<2.6
Receives: Other: Intensive Care
Routine Care (RC)No interventionParticipants treated in the routine manner by their rheumatologist (not treated to the target of DAS28<2.6)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 9 Visit

Secondary outcomes (5)

  1. 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

    Measured: Month 3 Visit, Month 6 Visit, and Month 9 Visit

  2. Absolute change in DAS28

    To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.

    Measured: Month 3 Visit, Month 6 Visit, Month 9 Visit

  3. 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

    Measured: Month 3 Visit, Month 6 Visit, Month 9 Visit

  4. 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%.

    Measured: Month 3 Visit, Month 6 Visit, Month 9 Visit

  5. 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.

    Measured: Month 3 Visit, Month 6 Visit, Month 9 Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: no enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01692912
Sponsor's protocol ID
PRC-05-2011
Acronym
PRC-05-2011
Status last verified
Apr 2017
First submitted
21 Sep 2012
Last updated
7 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Care in people with Psoriatic Arthritis (PsA), run by Pope Research Corporation at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving low DAS (time frame: Month 9 Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01692912.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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