A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium

Sponsor
Amgen
Study ID
NCT03097003
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Apremilast — DRUG
    Psoriasis patients treated with Otezla® (Apremilast) in Belgium

Study Details

OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the study treatment. As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice.

Key Dates

First listed
Mar 31, 2017
Start date
Apr 6, 2017
Status verified
Apr 2020
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018

Study Design

Enrollment
124 participants (actual)

Arms

  • Arm: Use of Apremilast in patient with plaque psoriasis
    Psoriasis patients treated with Otezla® (Apremilast) in Belgium

Primary Outcome Measure

Proportion of patients with Patient Benefit Index for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation. [ Time Frame: Up to 6 Months ]

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