Effect of Secukinumab in the Treatment of Psoriatic Arthritis

Sponsor
University of Liverpool
Study ID
NCT02854163
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Secukinumab — DRUG
    All eligible patients registered into the study will receive four 150 - 300 mg subcutaneous injections at weekly intervals, followed by regular injections 150mg once a month thereafter for a total of 12 months

Study Details

The investigators propose an open label pragmatic clinical and laboratory study designed to investigate, in detail, the clinical and molecular effects of Interleukin 17 (IL-17) and inhibition of IL-17 with secukinumab, on neutrophil function in vitro and ex vivo. As secondary, exploratory objectives, the investigators will utilise the fact that secukinumab is to be administering to 20 patients with Psoriatic Arthritis (PsA) and investigate whether there is any relationship between vitamin D status and response to secukinumab, with respect to efficacy and adverse events. The results of this secondary exploratory analysis will inform the design of a larger, definitive study.

Key Dates

Start date
Oct 15, 2016
Status verified
Apr 2020
Primary completion
Sep 18, 2019
Completion
Sep 18, 2019

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Secukinumab
    Secukinumab will be given to all 20 patients registered (Secukinumab group). All doses will be given subcutaneously using the following schedule: 4 weekly injections of 150 or 300 mg subcutaneous injections depending the severity of skin involvement, followed by 11 monthly subcutaneous injections of 150mg. Patients will continue to use their normal DMARDs treatment.

Primary Outcome Measure

Change from baseline in neutrophil apoptosis in PsA patients treated with Secukinumab at 12 months [ Time Frame: 12 months ]

Related Studies