An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

NCT ID: NCT04967950

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-12-31

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secukinumab 300mg

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

Group Type: EXPERIMENTAL

Secukinumab 300 MG

Intervention Type: DRUG

Secukinumab 150 mg s.c. with loading dose at baseline, week 1,2,3,4 and then every 4 weeks from week 5 up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, Secukinumab 150 mg will be with a switch to 300 mg.

Secukinumab 150mg

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

Group Type: EXPERIMENTAL

Secukinumab 150 MG

Intervention Type: DRUG

Methotrexate 15 mg po. every week up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, methotrexate with a switch to Secukinumab 150 mg at 12 weeks.

methotrexate

methotrexate

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

methotrexate

Interventions

Secukinumab 300 MG

Secukinumab 150 mg s.c. with loading dose at baseline, week 1,2,3,4 and then every 4 weeks from week 5 up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, Secukinumab 150 mg will be with a switch to 300 mg.

Intervention Type: DRUG

Secukinumab 150 MG

Methotrexate 15 mg po. every week up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, methotrexate with a switch to Secukinumab 150 mg at 12 weeks.

Intervention Type: DRUG

Methotrexate

methotrexate

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaomei Leng, Dr.

Role: CONTACT

lpumch@126.com

+8613681057089

Facility Contacts

Xiaomei Leng

Role: primary

lpumch@126.com

+8613681057089

Other Identifiers

PUMCH-IL17

Identifier Type: -

Identifier Source: org_study_id