Psoriatic ArthritisPaGoPsANCT03620188
Treatment Goals in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are we Meeting Patient Treatment Goals With Guideline-based Therapy for 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.
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Standard of care
- Keywords
- Patient treatment goals
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of reaching PsA treatment goals/treatment success from a patient perspective.
The primary outcome determination is based on the patients' report of whether they are/are not at goal with their PsA treatment.
Measured: 12-16 weeks
Secondary outcomes (5)
To define a status of PsA treatment where patient treatment goals have been met.
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.
Measured: 52 weeks
Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.
Meaningful change values in patients who transition longitudinally from goals not met to goals met.
Measured: 12-16 weeks
Worsening thresholds (treatment failure) if transition is from goals met to not met.
Meaningful change values in patients who transition longitudinally from goals met to goals not met disease activity categories.
Measured: 12-16 weeks
Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective
Prevalence of patients reporting they met PsA treatment goals (successful treatment) from their perspective.
Measured: 52 weeks
Stability of a state of treatment goals met at subsequent study visits.
Frequency and direction of longitudinal transitions between treatment goals/met not met states: 3 observations/participant.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start20 Dec 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Ana-Maria Orbai, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620188
- Sponsor's protocol ID
- IRB00184580
- Acronym
- PaGoPsA
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2018
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27613807
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are we Meeting Patient Treatment Goals With Guideline-based Therapy for Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT03620188
- Acronym / sponsor ID
- PaGoPsA / IRB00184580
- Conditions
- Psoriatic Arthritis
- Keywords
- Patient treatment goals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of careStandard 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. | Other | – |
Primary outcome
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.
5 secondary outcomes
To define a status of PsA treatment where patient treatment goals have been met.
Time frame: 52 weeks
Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.
Time frame: 12-16 weeks
Worsening thresholds (treatment failure) if transition is from goals met to not met.
Time frame: 12-16 weeks
Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective
Time frame: 52 weeks
Stability of a state of treatment goals met at subsequent study visits.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 27613807Orbai 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.
- Prior work on patient priorities for psoriatic arthritis treatmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Orbai, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of reaching PsA treatment goals/treatment success from a patient perspective. (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.