An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04967950
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab 300 MG — 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 150 MG — 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 — DRUG
    methotrexate

Study Details

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.

Key Dates

Start date
Jul 15, 2021
Status verified
Jun 2021
Primary completion
Oct 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab 300mg
    Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
  • Experimental: Secukinumab 150mg
    Randomized in a 1:1:1 ratio to secukinumab 300mg or secukinumab 150mg or MTX 15mg qw
  • Active Comparator: methotrexate
    methotrexate

Primary Outcome Measure

Change from Baseline in the Madrid Sonographic Enthesis Index (MASEI) ultrasound enthesitis score [ Time Frame: Baseline，Week 12 and Week 24 ]

Central Contacts

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