An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    60
  • sponsor
    Peking Union Medical College Hospital
Updated on 28 July 2021
methotrexate
psoriasis
secukinumab
arthritis
enthesitis
plaque psoriasis
biological drug

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.

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Arthritis
Treatment methotrexate, Secukinumab 300 mg, secukinumab 150 mg
Clinical Study IdentifierNCT04967950
SponsorPeking Union Medical College Hospital
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

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
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