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Treatment Goals in Psoriatic Arthritis (PaGoPsA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620188
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Psoriatic Arthritis 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.

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Are we Meeting Patient Treatment Goals With Guideline-based Therapy for Psoriatic Arthritis
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Standard 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620188


Locations
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United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Amgen
Investigators
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Principal Investigator: Ana-Maria Orbai, MD, MHS Johns Hopkins University
Additional Information:
Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03620188    
Other Study ID Numbers: IRB00184580
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Patient treatment goals
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases