Treatment Goals in Psoriatic Arthritis (PaGoPsA)

Are we Meeting Patient Treatment Goals With Guideline-based Therapy for Psoriatic Arthritis

The PaGoPsA study objective is to ascertain if guideline-based psoriatic arthritis clinical care achieves individual patient goals as articulated by patients, and to identify predictors of achieving individual patient goals from psoriatic arthritis treatment.

Study Overview

• Status: Completed
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Other: Standard of care

Detailed Description

Psoriatic arthritis (PsA) is a heterogeneous autoimmune disease that occurs in one in three people with the skin disease psoriasis. PsA can cause arthritis (joint inflammation), enthesitis (tendon and ligament inflammation), sausage digits (swollen entire finger or toe), spondyloarthritis (spinal inflammation). Skin involvement by psoriasis is also highly variable in terms of psoriasis type and location. Through combined skin and musculoskeletal involvement, psoriatic disease has a significant life impact with decrease quality of life including uncomfortable symptoms, ability to participate in life and functioning. Medications used to treat PsA have sometimes an uneven effect on the various PsA manifestations where some are more effective for skin while others more effective for the joints. In this context, clinical care and treatment of PsA is a complex process which balances disease activity with medication risks and benefits as well as patient priorities. Professional PsA treatments guidelines state that PsA treatment goals are disease remission or low disease activity. Several studies to date have shown that physicians tend to overestimate remission and low disease activity in PsA patients when compared to disease activity indices. Also patients and physicians frequently do not align on perceptions of remission or low disease activity. In the proposed study the investigators aim to identify predictors of successful treatment from a patient perspective on a range of disease measures including psoriasis, arthritis, enthesitis, dactylitis, patient reported outcomes, and laboratory assessments which are routinely collected in the clinical care of PsA. Secondary endpoints are to quantify longitudinally how stable a state of treatment success is from a patient perspective, and to define score ranges for disease measurements, including health-related quality of life measures, that correspond to treatment success from a patient perspective. The impact of this research is that the investigators will be able to define parameters predictive of achieving treatment success from a patient perspective, which will then inform goals of care for psoriatic arthritis.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adults with a diagnosis of psoriatic arthritis meeting CASPAR classification criteria for psoriatic arthritis who are followed every 3-4 months for regular rheumatologic care. Consecutive clinic patients will be recruited.

Description

Inclusion Criteria:

• English speaking/reading adults
• Patients of the Johns Hopkins Arthritis Center and/or the Johns Hopkins Psoriatic Arthritis Clinical Program
• Followed every 3-4 months for regular psoriatic arthritis clinical care
• Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
• Able to interact with touch screen computer.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of reaching PsA treatment goals/treatment success from a patient perspective.	The primary outcome determination is based on the patients' report of whether they are/are not at goal with their PsA treatment.	12-16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To define a status of PsA treatment where patient treatment goals have been met.	Score ranges that correspond to a status of patients' treatment goals met on a set of PsA outcome measures used in the study, including composite disease activity measures.	52 weeks
Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.	Meaningful change values in patients who transition longitudinally from goals not met to goals met.	12-16 weeks
Worsening thresholds (treatment failure) if transition is from goals met to not met.	Meaningful change values in patients who transition longitudinally from goals met to goals not met disease activity categories.	12-16 weeks
Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective	Prevalence of patients reporting they met PsA treatment goals (successful treatment) from their perspective.	52 weeks
Stability of a state of treatment goals met at subsequent study visits.	Frequency and direction of longitudinal transitions between treatment goals/met not met states: 3 observations/participant.	52 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Amgen
• Investigators: Principal Investigator: Ana-Maria Orbai, MD, MHS, Johns Hopkins University

Publications and helpful links

General Publications

• Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY, Tillett W, Elmamoun M, Callis Duffin K, Campbell W, Christensen R, Coates L, Dures E, Eder L, FitzGerald O, Gladman D, Goel N, Grieb SD, Hewlett S, Hoejgaard P, Kalyoncu U, Lindsay C, McHugh N, Shea B, Steinkoenig I, Strand V, Ogdie A. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis. 2017 Apr;76(4):673-680. doi: 10.1136/annrheumdis-2016-210242. Epub 2016 Sep 9.

Helpful Links

• Prior work on patient priorities for psoriatic arthritis treatment

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Patient treatment goals
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: IRB00184580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No