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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| NYU Langone Health | OTHER |
| University of Utah | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Group | This is an observational study with only one group/cohort with no intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatology clinic patients with active PsA switching to or adding a TNFi.
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Ogdie, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10003 | United States | ||
| Cleveland Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38101918 | Derived | 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. |
| Label | URL |
|---|---|
| Responsiveness and Minimum Clinically Important Difference in Patient-Reported Outcome Measures Among Patients With Psoriatic Arthritis: A Prospective Cohort Study | View source |
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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.
This data will be accessible throughout and after completion of the study.
The de-identified information stored in the redcap will available only to the study teams at each of the sites involved in this study and to those PIs for future research. Researchers not involved in this study will not be permitted to request or use data or samples from this study.
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171 unique participants were enrolled in the study, but there were 266 instances of treatment initiation analyzed (each participant could initiate >1 therapy).
Of the 266 instances of treatment initiation, not all outcome measures were completed at both Baseline and Month 3. Therefore, some outcome measures have a smaller number of units analyzed to include only those completed at both timepoints.
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With PsA Starting a New Therapy | This is an observational study with only one group - participants with PsA starting a new therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Among the 171 unique participants, there were 266 instances of treatment initiation analyzed (each participant could initiate >1 therapy)
| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | This is an observational study with only one group/cohort with no intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 225 completed RAPID3 at Baseline and Month 3 | Posted | Mean | Standard Deviation | change in score | 3 Months | treatment initiations | treatment initiations |
|
AE data were collected for each participant for 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Group | This is an observational study with only one group/cohort with no intervention |
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171 unique participants were enrolled in the study, but there were 266 instances of treatment initiation analyzed (each participant could initiate >1 therapy).
Of the 266 instances of treatment initiation, not all outcome measures were completed at both Baseline and Month 3. Therefore, some outcome measures have a smaller number of units analyzed to include only those completed at both timepoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexis Ogdie-Beatty | University of Pennsylvania | 215-614-2454 | alexis.ogdie@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2019 | Jan 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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Approximately 40 mL (4 tubes) of blood will be drawn at each of 2 visits. The blood and information collected throughout this study will be used to build a repository for future research projects. The de-identified information stored in the redcap will available only to the study teams at each of the sites involved in this study and to those PIs for future research. Blood samples will be processed and stored at individual sites. De-identified blood samples may be shipped to a central location for further testing on bio-markers of treatment response and disease progression.
Participants may retract permission and ask that their samples be destroyed. Information from these samples is exploratory and will not be shared with participants or included in medical records
| 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. | 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). | 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. | 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. | 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. | 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. | 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. | 3 Months |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Hospital at the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease | View source |
| treatment initiations |
|
| years |
| treatment initiations |
|
| Sex: Female, Male | Count of Units | treatment initiations | treatment initiations |
|
| Ethnicity (NIH/OMB) | Count of Units | treatment initiations | treatment initiations |
|
| Race (NIH/OMB) | Count of Units | treatment initiations | treatment initiations |
|
| Tender joint count | Mean | Standard Deviation | joints | treatment initiations |
|
| Swollen joint count | Mean | Standard Deviation | joints | treatment initiations |
|
| Body surface area (%) | Mean | Standard Deviation | % | treatment initiations |
|
| Enthesitis count | Mean | Standard Deviation | entheses | treatment initiations |
|
| Dactylitis count | Mean | Standard Deviation | digits | treatment initiations |
|
|
|
| Secondary | 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. | 85 participants completed HAQ-DI at Baseline and Month 3 | Posted | Mean | Standard Deviation | change in score | 3 Months | treatment initiations | treatment initiations |
|
|
|
| Secondary | 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. | 183 instances of therapy initiation completed PROMIS10 PH at Baseline and Month 3. | Posted | Mean | Standard Deviation | change in score | 3 Months | therapy initiation | therapy initiation |
|
|
|
| Secondary | 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). | 225 instances of therapy initiation completed PSAID at Baseline and Month 3. | Posted | Mean | Standard Deviation | change in score | 3 Months | therapy initiations | therapy initiations |
|
|
|
| Secondary | 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. | 256 instances of therapy initiation had swollen joint count measured at Baseline and Month 3 | Posted | Mean | Standard Deviation | change in joint count | 3 Months | therapy initiations | therapy initiations |
|
|
|
| Secondary | 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. | 256 instances of therapy initiation had tender joint count measured at Baseline and Month 3. | Posted | Mean | Standard Deviation | change in joint count | 3 Months | therapy initiations | therapy initiations |
|
|
|
| Secondary | 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. | 234 instances of therapy initiation completed the Pt Pain assessment at Baseline and Month 3. | Posted | Mean | Standard Deviation | change of score | 3 Months | therapy initiations | therapy initiations |
|
|
|
| Secondary | 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. | 249 instances of therapy initiation had a Physician Global Assessment at Baseline and Month 3. | Posted | Mean | Standard Deviation | change in score | 3 Months | therapy initiations | therapy initiations |
|
|
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| Secondary | 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. | 234 instances of therapy initiation completed the Pt Global assessment at Baseline and Month 3. | Posted | Mean | Standard Deviation | change in score | 3 Months | therapy initiations | therapy initiations |
|
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|
| 0 |
| 171 |
| 0 |
| 171 |
| 0 |
| 171 |
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |