Psoriatic arthritis from a mechanistic perspective.
Georg Schett, Proton Rahman, Christopher Ritchlin...
https://pubmed.ncbi.nlm.nih.gov/35513599Actively Recruiting
Age: 18Years +
All Genders
ID06987292
Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler Ultrasonography (PDUS) in a Prospective, Open-label Study
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-05-23
50
Participants Needed
2
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the effects of IL-17 inhibitors on subclinical enthesitis in adults with moderate to severe psoriasis. The study is observational, prospective, and open-label, aiming to assess the safety and effectiveness of these inhibitors using Power Doppler Ultrasonography (PDUS) to detect enthesitis. It focuses on patients with inflammatory changes at peripheral attachment points, which are not yet clinically apparent. Participants will receive IL-17 inhibitor treatment as part of routine care, with study evaluations occurring over a 52-week period. The primary outcome is the change in the Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24. Secondary outcomes include changes in GUESS at various time points, resolution of enthesitis, bone changes, skin assessments, pain scores, and progression to psoriatic arthritis. Throughout the study, participants will undergo ultrasound assessments and clinical evaluations at multiple visits up to week 52. Researchers will monitor skin and joint symptoms, pain levels, and structural changes using various scoring tools. Safety and treatment effects will be tracked prospectively, with participant involvement lasting approximately one year.
CONDITIONS
Brief Title
A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with chronic plaque-type psoriasis
- Have a Psoriasis Area and Severity Index (PASI) score greater than 6, or scalp involvement, or nail involvement
- Show inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point
- Psoriasis is inadequately controlled by current topical therapy or phototherapy
- Able to provide informed consent
You will not qualify if you...
- Diagnosis of psoriatic arthritis according to CASPAR criteria
- Presence of any known rheumatic disease or positive rheumatoid factor/anti-citrullinated protein antibodies
- Prior treatment with anti-rheumatic drugs
- Treatment with systemic corticosteroids within 12 weeks or 5 half-lives before screening
- Obesity that impedes ultrasound examination
- Pregnant or lactating women or women planning conception within 5 months before or after treatment
- Participation in other clinical trials
- Significant medical problems including uncontrolled hypertension, severe heart failure, low blood cell counts, abnormal liver or kidney function
- History or evidence of tuberculosis or chronic infections such as HIV, hepatitis B or C
- History of malignancy within past 5 years
- Unable or unwilling to undergo repeated blood draws
- History of alcohol or drug abuse within 6 months prior to baseline
- Known hypersensitivity to any component of the study drug
- Did not accept live vaccines within 4 weeks prior to enrollment and no planned live vaccines during study or within 6 months after last dose
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 52 weeks
Participants receive IL-17 inhibitors as treatment for moderate to severe psoriasis with subclinical enthesitis.
Visits at weeks 4, 12, 24, 36, and 52
Trial Site Locations
Total: 2 locations
1
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
2
Department of Dermatology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
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Research Team
W
Wenjun Hou, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Advantages of ultrasound imaging for the early diagnosis of psoriatic arthritis in patients with moderate to severe psoriasis.
Rongfen Chen, Xiaoyuan Zhong, Dawei Huang...
https://pubmed.ncbi.nlm.nih.gov/39055795Ultrasonography in the assessment of peripheral joint involvement in psoriatic arthritis : a comparison with radiography, MRI and scintigraphy.
S M Weiner, S Jurenz, M Uhl...
https://pubmed.ncbi.nlm.nih.gov/18259687Ultrasonography of entheseal insertions in the lower limb in spondyloarthropathy.
P V Balint, D Kane, H Wilson...
https://pubmed.ncbi.nlm.nih.gov/12228161