Psoriatic Arthritis
Conditions
Keywords
Patient treatment goals
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.
Interventions
OTHERStandard of care
Standard of care in PsA is outline in treatment guidelines as adjustment of therapy every 3 months until goals of treatment are being met. Goals of treatment are defined as remission or low disease activity.
Sponsors
Amgen
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed