Treatment Goals in Psoriatic Arthritis

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: NCT03620188
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-08
• Study Start: 2018-12-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Bayview; 🇺🇸 Baltimore, Maryland, United States