EBIO - Enthesitis Biopsy Study

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT04887597
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab — DRUG
    The study is composed of a single arm receiving secukinumab for the duration of 6 months.

Study Details

The purpose of this Phase IV study is to determine the effect of secukinumab on total immune cell numbers obtaines by entheseal biopsy in the inflamed human entheses in patients with Psoriatic Arthritis. This is a single arm, single centre, prospective, open label study with secukinumab.

Key Dates

Start date
Mar 18, 2019
Status verified
May 2021
Primary completion
Mar 31, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Secukinumab Treatment
    all patients receive Secukinumab as well as a biopsy before and after treatment

Primary Outcome Measure

Percent of patients with reduction of total immune cell (PMN, M, T cells, B cells, ILC3, Mast cells) numbers by at least 50 percent in the enthesial tissue after 24 weeks of treatment with secukinumab [ Time Frame: baseline and 6 months ]

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