Psoriasis-Arthritis & Bone Program

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT02483234
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Purpose and rationale: To define the role of IL-17 as a mediator of structural bone lesions in psoriasis patients and patients with PsA. Primary Objective is the improvement of the PsAMRIS synovitis score baseline vs. week 24. Drug tested is Secukinumab 300 mg administered weekly for 4 weeks, then 4 weekly s.c. with a duration total of 24 weeks. Indication for this study is Psoriasis (Pso) and psoriatic arthritis (PsA).

Key Dates

Start date
May 31, 2015
Status verified
Sep 2019
Primary completion
Jun 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psoriasis/Psoriatic arthritis
    Patients with Psoriasis and inflammatory and/or structural lesions and/or erosions in the MRI/HR-qCT scan will be treated with Secukinumab. Patients with psoriatic arthritis will be treated with Secukinumab. Bone changes will be evaluated influenced by IL-17 blockade

Primary Outcome Measure

The improvement of the PsAMRIS synovitis score [ Time Frame: baseline to week 24 ]

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