NCT04967950

An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

An Efficacy Study of Secukinumab in Enthesitis of Psoriatic Arthritis Patients as Measured by Imaging Test

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
DRUG	Methotrexate	methotrexate

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2021-07-20
• Last updated: 2021-07-20

Locations

1 site across 1 country: China