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Completed

NCT Number: NCT03620188

Treatment Goals in 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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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.

Primary outcomes

  1. Predictors of reaching PsA treatment goals/treatment success from a patient perspective.

    Time frame: 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 outcomes

  1. To define a status of PsA treatment where patient treatment goals have been met.

    Time frame: 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.

  2. Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.

    Time frame: 12-16 weeks

    Meaningful change values in patients who transition longitudinally from goals not met to goals met.

  3. Worsening thresholds (treatment failure) if transition is from goals met to not met.

    Time frame: 12-16 weeks

    Meaningful change values in patients who transition longitudinally from goals met to goals not met disease activity categories.

  4. Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective

    Time frame: 52 weeks

    Prevalence of patients reporting they met PsA treatment goals (successful treatment) from their perspective.

  5. Stability of a state of treatment goals met at subsequent study visits.

    Time frame: 52 weeks

    Frequency and direction of longitudinal transitions between treatment goals/met not met states: 3 observations/participant.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Amgen

Registry information

Official study title

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

Acronym: PaGoPsA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2018
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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