Psoriatic ArthritisPARC-BNCT03378336
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
An observational study of Psoriatic Arthritis, run by University of Pennsylvania at 4 sites in United States.
Trial summary
Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 171 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Dec 2017to 16 Aug 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- Adult, Older adult
Study population: Rheumatology clinic patients with active PsA switching to or adding a TNFi.
Who may be able to join
- Age 18-89
- Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)
Who cannot join
- Unable to give informed consent
- Out of the age range
- Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms.
- Patients with only active PsA
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
NYU School of Medicine
New York, New York, 10003
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132
About this study
Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.
- Conditions
- Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | This is an observational study with only one group/cohort with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Function Response to Biologic Therapy as Measured by RAPID3
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit.
RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = moderate; 3.1-6 = low; < or =3 = remission.
Measured: 3 Months
Secondary outcomes (8)
Patient Function Response to Biologic Therapy as Measured by HAQ-DI
Patient's perception of response to therapy as related to patient functionality. Measured by change in HAQ-DI score from baseline to 3 month visit.
The HAQ-DI (Health Assessment Questionnaire - Disability Index) covers 20 items in eight domains related to measuring difficulty in performing activities of daily living. Each question is rated on a 0-3 scale, where 0 indicates "without difficulty" and 3 indicates "unable to do." The highest score in each domain is accepted as the score in that domain. Scores for the 8 domains are averaged to compute final score between 0 and 3. Scores 0-1 indicate mild to moderate disability, 1-2 indicate moderate to severe disability, and 2-3 indicate severe to very severe disability.
Measured: 3 Months
Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10
Patient's perception of response to therapy as related to quality of life. Measured by change in PROMIS10 Physical Health score from baseline to 3 month visit.
PROMIS10 (Patient-Reported Outcomes Measurement Information System) Physical Health is a 10-item questionnaire, each with a five point scale from Poor to Excellent. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100). Increasing score indicates improvement.
Measured: 3 Months
Patient Quality of Life Response to Biologic Therapy as Measured by PSAID
Patient's perception of response to therapy as related to quality of life. Measured by change in PSAID score from baseline to 3 month visit.
PSAID (PsA Impact of Disease) is a questionnaire composed of 12 health domains, examining different perspectives (both physical and psychological). Each domain is evaluated by a single question with a range from 0-10 in which higher results indicate a greater impact of the disease. Individual domain scores are weighted to indicate those with a greater effect, then the sum of weighted domain scores is divided by 20 to compute the final score (range 0-10).
Measured: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.
Measured: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.
Measured: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Pain Assessment from baseline to 3 month visit.
The Patient Pain Assessment is measured on a scale of 0-100 where a higher score indicates worse pain.
Measured: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Physician Global Assessment from baseline to 3 month visit.
Physician Global Assessment is measured on a scale from 0-10 where a higher score indicates greater disease impact.
Measured: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Global Assessment from baseline to 3 month visit.
Patient Global Assessment is measured on a scale of 0-10 where a higher score indicates greater disease impact.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start31 Dec 2017
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of PennsylvaniaThe 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, NYU Langone Health, University of Utah
- Responsible party
- Sponsor
- Investigators
- Alexis Ogdie, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378336
- Sponsor's protocol ID
- 828357
- Acronym
- PARC-B
- Status last verified
- May 2025
- First submitted
- 27 Nov 2017
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All four institutions use the Epic electronic medical record system and have existing REDCap databases. For the purpose of this study and use in future studies, we will build a PARC Core REDCap Database. All four institutions will have access to this Core REDCap Database with designated data use agreements. The PARC Core REDCap Database will then be populated from each of our existing institutional RedCap databases. Personal identifiers (name, medical record number) will not be stored as a part of this dataset. Instead, personal identifiers will remain within each individual institution and only de-identified data placed in the Core REDCap database. To ensure the protection of the subjects and data integrity, we will maintain the highest security settings for the Core REDCap Database.
Publications
Reddy SM, Xue K, Husni ME, Scher JU, Stephens-Shields AJ, Goel N, Koplin J, Craig ET, Walsh JA, Ogdie A. Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease. J Rheumatol. 2024 Feb 1;51(2):139-143. doi: 10.3899/jrheum.2023-0504.
PubMed 38101918
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
- ClinicalTrials.gov ID
- NCT03378336
- Acronym / sponsor ID
- PARC-B / 828357
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, NYU Langone Health, University of Utah
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | –This is an observational study with only one group/cohort with no intervention |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Rheumatology clinic patients with active PsA switching to or adding a TNFi.
Key inclusion criteria (2 listed)
- Age 18-89
- Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)
Key exclusion criteria (4 listed)
- Unable to give informed consent
- Out of the age range
- Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms.
- Patients with only active PsA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Function Response to Biologic Therapy as Measured by RAPID3
Time frame: 3 Months
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: >12 = high; 6.1-12 = moderate; 3.1-6 = low; < or =3 = remission.
8 secondary outcomes
Patient Function Response to Biologic Therapy as Measured by HAQ-DI
Time frame: 3 Months
Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10
Time frame: 3 Months
Patient Quality of Life Response to Biologic Therapy as Measured by PSAID
Time frame: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
Time frame: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38101918Reddy SM, Xue K, Husni ME, Scher JU, Stephens-Shields AJ, Goel N, Koplin J, Craig ET, Walsh JA, Ogdie A. Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease. J Rheumatol. 2024 Feb 1;51(2):139-143. doi: 10.3899/jrheum.2023-0504.
- Responsiveness and Minimum Clinically Important Difference in Patient-Reported Outcome Measures Among Patients With Psoriatic Arthritis: A Prospective Cohort StudyLink provided by the sponsor.
- Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All four institutions use the Epic electronic medical record system and have existing REDCap databases. For the purpose of this study and use in future studies, we will build a PARC Core REDCap Database. All four institutions will have access to this Core REDCap Database with designated data use agreements. The PARC Core REDCap Database will then be populated from each of our existing institutional RedCap databases. Personal identifiers (name, medical record number) will not be stored as a part of this dataset. Instead, personal identifiers will remain within each individual institution and only de-identified data placed in the Core REDCap database. To ensure the protection of the subjects and data integrity, we will maintain the highest security settings for the Core REDCap Database.
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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.
Alexis Ogdie, MD principal investigator
University of Pennsylvania
4 sites 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 University of Pennsylvania at 4 sites 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 2 inclusion and 4 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 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Function Response to Biologic Therapy as Measured by RAPID3 (time frame: 3 Months). 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 NCT03378336, 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 9 May 2025.