An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 1

Conditions: Psoriatic Arthritis

Treatments: Drug: Secukinumab 300 MG; Drug: Secukinumab 150 MG; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT04967950

PUMCH-IL17

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Secukinumab 300mg

Experimental group

Description:

Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw

Treatment:

Drug: Secukinumab 300 MG

Secukinumab 150mg

Experimental group

Description:

Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw

Treatment:

Drug: Secukinumab 150 MG

methotrexate

Active Comparator group

Description:

methotrexate

Treatment:

Drug: Methotrexate