Suspended
An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test
What is being tested
Secukinumab 300 MG
+ Secukinumab 150 MG
+ Methotrexate
Drug
Who is being recruted
Arthritis+10
+ Bone Diseases
+ Joint Diseases
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: July 2021
Summary
Principal SponsorPeking Union Medical College Hospital
Study ContactXiaomei Leng, Dr.
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: July 15, 2021
Actual date on which the first participant was enrolled.Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of enthesitis in psoriatic arthritis patients. This study will be the first randomized trial of a biologic therapy in participants with psoriatic arthritis, using imaging test.
Official TitleAn Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test
Principal SponsorPeking Union Medical College Hospital
Study ContactXiaomei Leng, Dr.
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesPsoriasisSkin DiseasesSpinal DiseasesSpondylitisArthritis, PsoriaticSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathies
Criteria
5 inclusion criteria required to participate
aged 18 years or older,;
had received a diagnosis of psoriatic arthritis at least 6 months previously, fulfilled the Classification Criteria for Psoriatic Arthritis (CASPAR);
had at least 1 active enthesitis (confirmed by ultrasound) ;
had active arthritis (at least 3 tender/painful and 3 swollen joints) ;
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5 exclusion criteria prevent from participating
History of surgery or trauma at the site examined by ultrasound (hand, elbow, knee, ankle, etc.);
Local injection of glucocorticoids or other drugs at the site examined by ultrasound in recent 6 weeks;
Peripheral neuropathy;
Use of IL-17 or IL-12/23 inhibitors in the last 12 months;Use of infliximab, adamumab, golimumab, and cetuzumab in the last 10 weeks;PUVA treatment for the last 4 weeks;Use of topical treatment or UVB phototherapy that may have an effect on psoriasis in the last 2 weeks;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalRandomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
Group II
ExperimentalRandomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
Group III
Active Comparatormethotrexate
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, ChinaOpen Chinese Academy of Medical Sciences & Peking Union Medical College in Google MapsSuspendedOne Study Center