- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386717
Upadacitinib Versus IL-17 Inhibitors in Patients With Psoriatic Arthritis (UVIPWP)
Upadacitinib Versus IL-17 Inhibitors in Patients With Psoriatic Arthritis: A Cohort Study
Psoriatic arthritis (PsA) is a chronic inflammatory disease with heterogeneous musculoskeletal and dermatologic manifestations, leading to significant functional impairment and reduced quality of life. Although targeted therapies such as Janus kinase inhibitors and interleukin-17 inhibitors have demonstrated efficacy in randomized controlled trials, real-world comparative evidence between these treatment strategies remains limited.
This observational cohort study aims to compare the real-world effectiveness and safety of upadacitinib and interleukin-17 inhibitors in patients with PsA over a 24-week follow-up period. By evaluating clinical outcomes under routine clinical practice conditions, this study seeks to provide evidence to support individualized treatment selection in PsA management.
Study Overview
Status
Detailed Description
This is a real-world, observational cohort study conducted at Peking University First Hospital. Adult patients diagnosed with psoriatic arthritis will be enrolled and followed for 24 weeks in routine clinical practice.
Participants will be categorized into two cohorts based on treatment exposure at baseline: patients receiving upadacitinib and patients receiving interleukin-17 inhibitors. Treatment decisions are made by treating physicians according to standard clinical practice and are not influenced by the study protocol.
Clinical assessments will be performed at baseline and during routine follow-up visits within the 24-week observation period. Effectiveness outcomes will be evaluated across musculoskeletal and dermatologic domains, and safety outcomes will be monitored throughout follow-up. This study does not involve experimental interventions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Peking University First Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of psoriatic arthritis according to established classification criteria
- Treatment with upadacitinib or an interleukin-17 inhibitor at baseline
- Availability of baseline and follow-up clinical data over 24 weeks
Exclusion Criteria:
- Diagnosis of other inflammatory arthritides
- History of malignancy or severe uncontrolled infection
- Incomplete clinical data preventing outcome assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1: Upadacitinib-Treated PsA Patients
Adult patients with psoriatic arthritis receiving upadacitinib as part of routine clinical care and followed for 24 weeks.
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Cohort 2: IL-17 Inhibitor-Treated PsA Patients
Adult patients with psoriatic arthritis receiving interleukin-17 inhibitors (e.g., secukinumab or ixekizumab) as part of routine clinical care and followed for 24 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical effectiveness of treatment
Time Frame: Baseline to Week 24
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Changes in joint and skin disease activity assessed using validated clinical measures during the 24-week follow-up period.
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Baseline to Week 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVIPWP_V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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