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 — DRUGPsoriasis 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 psoriasisPsoriasis 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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