Clinical trial NCT03620188: Treatment Goals in Psoriatic Arthritis
Official title: Are we Meeting Patient Treatment Goals With Guideline-based Therapy for Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Patient treatment goals
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2018-08-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictors of reaching PsA treatment goals/treatment success from a patient perspective.
timeFrame: 12-16 weeks
Secondary outcomes:
measure: To define a status of PsA treatment where patient treatment goals have been met.
timeFrame: 52 weeks
measure: Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.
timeFrame: 12-16 weeks
measure: Worsening thresholds (treatment failure) if transition is from goals met to not met.
timeFrame: 12-16 weeks
measure: Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective
timeFrame: 52 weeks
measure: Stability of a state of treatment goals met at subsequent study visits.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ana-Maria Orbai, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.