NCT01692912

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

September 21, 2012

Last Update Submit

April 5, 2017

Conditions

Psoriatic Arthritis (PsA)

Keywords

Psoriatic ArthritisRandomizedSingle blindTreat to target

Outcome Measures

Primary Outcomes (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.

    Month 9 Visit

Secondary Outcomes (5)

  • Time to achieving DAS28<2.6

    Month 3 Visit, Month 6 Visit, and Month 9 Visit

  • Absolute change in DAS28

    Month 3 Visit, Month 6 Visit, Month 9 Visit

  • Percentage of Patients achieving ACR 20, 50, and 70

    Month 3 Visit, Month 6 Visit, Month 9 Visit

  • Percentage of patients achieving PsARC

    Month 3 Visit, Month 6 Visit, Month 9 Visit

  • Absolute change in HAQ-DI

    Month 3 Visit, Month 6 Visit, Month 9 Visit

Study Arms (2)

Intensive Care (IC)

ACTIVE COMPARATOR

Rheumatologists treating to target of DAS28\<2.6

Other: Intensive Care

Routine Care (RC)

NO INTERVENTION

Participants treated in the routine manner by their rheumatologist (not treated to the target of DAS28\<2.6)

Interventions

Intensive CareOTHER

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

Intensive Care (IC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pope Research Corp., 68 Green Acres Drive

London, Ontario, N6G 2S3, Canada

Location

The Arthritis Program Research Group

Newmarket, Ontario, Canada

Location

Arthur Karasik

Toronto, Ontario, M9C 5N2, Canada

Location

Institut de Rheumatologie de Montreal

Montreal, Quebec, H2L 1S6, Canada

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Critical Care

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Janet E. Pope, MD, MPH, FRCPC

    Pope Research Corp., University of Western Ontario, St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 25, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

CA(4)