Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-16
Brief Title:
Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis
Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Organization:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Overview
Official Title:
Ultrasound-based Response of Enthesitis to Upadacitinib in Psoriatic Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 24
Secondary objective
1 To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 12
2 To evaluate the clinical response of enthesitis to upadacitinib by LEI at week 12 and week 24
3 To evaluate the clinical response of disease activity by DAPSA at week 12 and week 24
Study Design single-arm observational longitudinal prospective study
Population The study population will consist of adult patients aged 18 years old and 65 years old with PsA according to CASPAR classification criteria who have been prescribed upadacitinib over the course of routine practice in accordance with the applicable approved label and local regulatory and reimbursement policies In patients with psoriatic arthritis upadacitinib would be a therapeutic alternative after failure inadequate response or intolerance to csDMARDs and anti-TNF and have at least one ultrasound-determined peripheral enthesitis
Secondary objective
1 To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 12
2 To evaluate the clinical response of enthesitis to upadacitinib by LEI at week 12 and week 24
3 To evaluate the clinical response of disease activity by DAPSA at week 12 and week 24
Study Design single-arm observational longitudinal prospective study
Population The study population will consist of adult patients aged 18 years old and 65 years old with PsA according to CASPAR classification criteria who have been prescribed upadacitinib over the course of routine practice in accordance with the applicable approved label and local regulatory and reimbursement policies In patients with psoriatic arthritis upadacitinib would be a therapeutic alternative after failure inadequate response or intolerance to csDMARDs and anti-TNF and have at least one ultrasound-determined peripheral enthesitis
Detailed Description:
Rationale and Background
Psoriatic arthritis PsA is a complex and heterogeneous skin-musculoskeletal disease with a broad clinical phenotype spectrum of mostly peripheral ie arthritis enthesitis dactylitis but also axial ie spondylitis manifestations Among PsA domains enthesitis in addition to being a hallmark of the disease has shown to be associated with higher disease activity disability and incapacity to work ultimately leading to poor quality of life In clinical practice and clinical trials in PsA enthesitis has traditionally been measured by physical examination or by clinical indices developed for spondyloarthritis SpA however clinical examination of entheses depends on eliciting tenderness on direct palpation of the insertional site and may be not only nonspecific and insensitive but also does not inform of the grade of inflammation or the presence of underlying structural changes Ultrasound has clearly demonstrated higher sensitivity than clinical assessment for detecting enthesitis in PsA patients Since 2008 under the umbrella of the Outcome Measures in Rheumatology OMERACT Ultrasound Group a subtask force for enthesitis was created to produce standardized agreed definitions of ultrasound-detected enthesitis components and a reliable scoring system for enthesitis
Following a stepwise consensus-based methodology the group agreed on the definitions of the elementary components of enthesitis and then decided which of them should be included in the final definition of an ultrasound-detected enthesitis for SpA PsA Since 2014 through a number of consecutive live scanning exercises on patients with SpA and PsA the intraobserver and interobserver reliability of the ultrasound elementary lesions and the scoring system of enthesitis was successfully tested Furthermore the responsiveness of ultrasound-determined enthesitis has been demonstrated in multicentre studies on patients with SpAPsA treated with TNF inhibitors
There are no studies on ultrasound-assessed enthesitis response to upadacitinib In patients who have an inadequate response IR to conventional synthetic cs DMARDs in SELECT-PsA 1 clinical trial both doses of upadacitinib demonstrated statistical differences versus placebo in clinical resolution of enthesitis according to LEI In bDMARD-IR patients SELECT-PsA 2 as an exploratory endpoint a greater proportion of patients reached clinical resolution of enthesitis by LEI and SPARCC on either dose of upadacitinib versus placebo The results of the current ultrasound-based study will further characterize the effectiveness of upadacitinib in the enthesitis domain
Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 24
Secondary objective
1 To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 12
2 To evaluate the clinical response of enthesitis to upadacitinib by LEI at week 12 and week 24
3 To evaluate the clinical response of disease activity by DAPSA at week 12 and week 24
Study Design single-arm observational longitudinal prospective study
Population The study population will consist of adult patients aged 18 years old and 65 years old with PsA according to CASPAR classification criteria who have been prescribed upadacitinib over the course of routine practice in accordance with the applicable approved label and local regulatory and reimbursement policies In patients with psoriatic arthritis upadacitinib would be a therapeutic alternative after failure inadequate response or intolerance to csDMARDs and anti-TNF and have at least one ultrasound-determined peripheral enthesitis
Variables
Primary endpoint Changes from baseline in B-mode and Doppler-mode enthesitis measured by the OMERACT enthesitis scoring system at 24 weeks of follow-up
Secondary endpoint Changes in B-mode and Doppler-mode enthesitis measured by the OMERACT enthesitis scoring system at 12 weeks
Change in DAPSA score between baseline to week 12 and baseline to week 24 Change in LEI score between baseline to week 12 and baseline to week 24
Descriptive variables Baseline 12 weeks 24 weeks Treatment for PsA Joint tenderness in 68 joints Joint swelling in 66 joints Patients assessment of pain NRS 0-10 Patients Global Assessment of Disease Activity PtGA Psoriatic Arthritis Impact of Disease PsAID12 SPARCC enthesitis index Presence of dactylitis in hands or feet C-reactive protein CRP Health Assessment Questionnaire-Disability Index HAQ-DI
Data Sources Patient medical records clinical and ultrasound assessments
Study Size 19 patients
Data Analysis
Categorical variables will be summarized with frequency and percentage Continuous variables will be summarized with descriptive statistics mean and standard deviation median minimum and maximum if these variables show a skewed distribution of values median and interquartile range will also be reported
Changes from baseline variation in the OMERACT enthesitis scoring DAPSA SPARCC and LEI score will be analysed by means of the Wilcoxon signed rank test for paired samples
Correlations between clinical and BMUSPDUS quantitative variables will be analysed using Spearmans correlation test If association is demonstrated it will be considered poor correlation if r 02 fair correlation if r02 and r 04 moderate correlation if r 04 and r 07 and strong correlation if r 07
Nominal p-value will be provided for associations
Psoriatic arthritis PsA is a complex and heterogeneous skin-musculoskeletal disease with a broad clinical phenotype spectrum of mostly peripheral ie arthritis enthesitis dactylitis but also axial ie spondylitis manifestations Among PsA domains enthesitis in addition to being a hallmark of the disease has shown to be associated with higher disease activity disability and incapacity to work ultimately leading to poor quality of life In clinical practice and clinical trials in PsA enthesitis has traditionally been measured by physical examination or by clinical indices developed for spondyloarthritis SpA however clinical examination of entheses depends on eliciting tenderness on direct palpation of the insertional site and may be not only nonspecific and insensitive but also does not inform of the grade of inflammation or the presence of underlying structural changes Ultrasound has clearly demonstrated higher sensitivity than clinical assessment for detecting enthesitis in PsA patients Since 2008 under the umbrella of the Outcome Measures in Rheumatology OMERACT Ultrasound Group a subtask force for enthesitis was created to produce standardized agreed definitions of ultrasound-detected enthesitis components and a reliable scoring system for enthesitis
Following a stepwise consensus-based methodology the group agreed on the definitions of the elementary components of enthesitis and then decided which of them should be included in the final definition of an ultrasound-detected enthesitis for SpA PsA Since 2014 through a number of consecutive live scanning exercises on patients with SpA and PsA the intraobserver and interobserver reliability of the ultrasound elementary lesions and the scoring system of enthesitis was successfully tested Furthermore the responsiveness of ultrasound-determined enthesitis has been demonstrated in multicentre studies on patients with SpAPsA treated with TNF inhibitors
There are no studies on ultrasound-assessed enthesitis response to upadacitinib In patients who have an inadequate response IR to conventional synthetic cs DMARDs in SELECT-PsA 1 clinical trial both doses of upadacitinib demonstrated statistical differences versus placebo in clinical resolution of enthesitis according to LEI In bDMARD-IR patients SELECT-PsA 2 as an exploratory endpoint a greater proportion of patients reached clinical resolution of enthesitis by LEI and SPARCC on either dose of upadacitinib versus placebo The results of the current ultrasound-based study will further characterize the effectiveness of upadacitinib in the enthesitis domain
Primary objective To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 24
Secondary objective
1 To evaluate the peripheral enthesitis response to upadacitinib treatment by BMUS and DMUS in PsA patients at week 12
2 To evaluate the clinical response of enthesitis to upadacitinib by LEI at week 12 and week 24
3 To evaluate the clinical response of disease activity by DAPSA at week 12 and week 24
Study Design single-arm observational longitudinal prospective study
Population The study population will consist of adult patients aged 18 years old and 65 years old with PsA according to CASPAR classification criteria who have been prescribed upadacitinib over the course of routine practice in accordance with the applicable approved label and local regulatory and reimbursement policies In patients with psoriatic arthritis upadacitinib would be a therapeutic alternative after failure inadequate response or intolerance to csDMARDs and anti-TNF and have at least one ultrasound-determined peripheral enthesitis
Variables
Primary endpoint Changes from baseline in B-mode and Doppler-mode enthesitis measured by the OMERACT enthesitis scoring system at 24 weeks of follow-up
Secondary endpoint Changes in B-mode and Doppler-mode enthesitis measured by the OMERACT enthesitis scoring system at 12 weeks
Change in DAPSA score between baseline to week 12 and baseline to week 24 Change in LEI score between baseline to week 12 and baseline to week 24
Descriptive variables Baseline 12 weeks 24 weeks Treatment for PsA Joint tenderness in 68 joints Joint swelling in 66 joints Patients assessment of pain NRS 0-10 Patients Global Assessment of Disease Activity PtGA Psoriatic Arthritis Impact of Disease PsAID12 SPARCC enthesitis index Presence of dactylitis in hands or feet C-reactive protein CRP Health Assessment Questionnaire-Disability Index HAQ-DI
Data Sources Patient medical records clinical and ultrasound assessments
Study Size 19 patients
Data Analysis
Categorical variables will be summarized with frequency and percentage Continuous variables will be summarized with descriptive statistics mean and standard deviation median minimum and maximum if these variables show a skewed distribution of values median and interquartile range will also be reported
Changes from baseline variation in the OMERACT enthesitis scoring DAPSA SPARCC and LEI score will be analysed by means of the Wilcoxon signed rank test for paired samples
Correlations between clinical and BMUSPDUS quantitative variables will be analysed using Spearmans correlation test If association is demonstrated it will be considered poor correlation if r 02 fair correlation if r02 and r 04 moderate correlation if r 04 and r 07 and strong correlation if r 07
Nominal p-value will be provided for associations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None