Psoriatic Arthritis Treat to Target vs. Usual Care

Psoriatic Arthritis (PsA) Clinical Trial

— PRC-05-2011  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01692912
• Other study ID #: PRC-05-2011
• Status: Withdrawn
• Phase: N/A
• First received: September 21, 2012
• Last updated: April 5, 2017
• Start date: October 2012
• Est. completion date: November 2014

Study information

• Verified date: April 2017
• Source: Pope Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 care.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis (PsA)

Intervention

Other:
• Intensive Care
Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6

Locations

Country	Name	City	State
Canada	Pope Research Corp., 68 Green Acres Drive	London	Ontario
Canada	Institut de Rheumatologie de Montreal	Montreal	Quebec
Canada	The Arthritis Program Research Group	Newmarket	Ontario
Canada	Arthur Karasik	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Pope Research Corporation	Amgen

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Month 3 Visit, Month 6 Visit, and Month 9 Visit
Secondary	Absolute change in DAS28	To compare the effectiveness of Intensive Care and Routine Care in improving the patient DAS28.	Month 3 Visit, Month 6 Visit, Month 9 Visit
Secondary	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	Month 3 Visit, Month 6 Visit, Month 9 Visit
Secondary	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%.	Month 3 Visit, Month 6 Visit, Month 9 Visit
Secondary	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.	Month 3 Visit, Month 6 Visit, Month 9 Visit