Clinical trial NCT04967950: An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients
Official title: An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Psoriatic Arthritis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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) ;
* had active plaque psoriasis (there was no criteria for minimum psoriasis severity) at screening and baseline.

Exclusion Criteria:

* 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;
* recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease; evidence of active or latent or inadequately treated Mycobacterium tuberculosis; aspartate transaminase (AST) or alanine transaminase (ALT) \>3x upper limit of normal (ULN) at screening; estimated creatinine clearance \<40 mL/min.

Primary outcomes:
measure: Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score
timeFrame: Baseline，Week 12 and Week 24
Secondary outcomes:
measure: Change from Baseline in the OMERACT Heel Enthesitis MRI Scoring System(HEMRIS)
timeFrame: Baseline and Week 24
measure: Change from Baseline in the PsASon13 unilateral ultrasound composite score of synovitis
timeFrame: Baseline，Week 12 and Week 24
measure: Proportion of patients achieving ACR20、ACR50 and ACR70 response.
timeFrame: Baseline，Week 12 and Week 24
measure: Number of participants who achieve Psoriasis Area and Severity Index 75 (PASI 75)
timeFrame: Baseline，Week 12 and Week 24
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) score
timeFrame: Baseline and Week 24
measure: Change from Baseline in HAQ-DI score
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
References: