Treatment With Apremilast in Patients With Psoriatic Arthritis

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT02558361
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Treatment with Apremilast — DRUG
    Standard dosing with apremilast (Otezla) will be used. \[30mg po BID after initial titration\]

Study Details

Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis. Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.

Key Dates

First listed
Sep 24, 2015
Start date
Apr 30, 2016
Status verified
Jun 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

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

Arms

  • Other: Open label, single arm
    Baseline visit:assess disease activity,synovial tissue biopsy of the knee with active synovitis \[target joint\] and punch skin biopsy of a target psoriatic plaque. Perform a similar punch skin biopsy on adjacent normal skin. Start apremilast (standard dosing). Perform venipuncture: blood samples will be obtained for routine studies, quantitative RT-PCR \& ex vivo cytokine production assays. UA/pregnancy test. Month 1: assess disease active , monitor for AE's; repeat punch skin biopsy of target psoriatic plaque. Blood samples will be obtained for RT-PCR and ex vivo cytokine production assays. Month 3: same as month 1; repeat synovial tissue biopsy from target knee joint and punch skin biopsy on target psoriatic plaque. Blood samples for RT-PCR ex vivo cytokine production assays and routine studies.

Primary Outcome Measure

Comparison of the change in the specific 32 gene products as measured by RT-PCR from baseline to Month 3 on synovial, skin samples (Co-primary endpoints) using the sign test. [ Time Frame: To be assessed by a change from baseline to month three ]

Locations (1)

FacilityCityStateZIPSite coordinators
Morsani Center for Advanced healthcareTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Morsani Center for Advanced healthcare· Tampa, FL

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