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Study Complete
Sponsor ID
CC-10004-PSOR-016

A study of the real-life management of psoriasis patients treated with Otezla® (apremilast) in BelgiumOTELO

Sponsor ID
CC-10004-PSOR-016
Clinicaltrials.gov ID
NCT03097003
EUCTIS ID
N/A
EudraCT ID
N/A
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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.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
124
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of patients with Patient Benefit Index for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation.

Timeframe: Up to 6 Months

Secondary Outcome Measures

Characteristics of the patients treated with apremilast

Timeframe: Baseline

Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation

Timeframe: Up to 6 Months

PBI-S outcome score after apremilast initiation

Timeframe: up to 18 months

Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation

Timeframe: up to 6 months

Change from baseline in the PtGA after apremilast initiation

Timeframe: up to 18 months

Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation.

Timeframe: Up to 6 Months

Change from baseline in the DLQI score after apremilast initiation

Timeframe: up to 18 months

Change from baseline in the psoriasis symptomatology

Timeframe: up to 18 months

Change from baseline in the patient-reported treatment satisfaction (TSQM-9)

Timeframe: up to 18 months

Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 or PASI 75 at 6 months after apremilast initiation

Timeframe: Up to 6 Months

Change from baseline in the disease activity scores in terms of Body Surface Area (BSA)

Timeframe: up to 18 months

Change from baseline in the disease activity scores in terms of PASI

Timeframe: up to 18 months

Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment

Timeframe: Up to 18 Months

Rate of discontinuation of apremilast treatment within 6 months after initiation

Timeframe: Up to 6 months

Adverse Events (AEs)

Timeframe: Up to 18 months

Locations

Location
Status
Contact Us
Location
UZ Leuven Sint Rafael
Leuven, Belgium, 3000
Status
Recruiting
Location
Private Practice Namur
Namur, Belgium, 5000
Status
Not yet recruiting
Location
CHU UCL Mont-Godinne
Godinne, Belgium, 5530
Status
Recruiting
Location
Clin Univ de Bxl Hôpital Erasme
Brussels, Belgium, 1070
Status
Recruiting
Location
AZ Sint Lucas
Gent, Belgium, 9000
Status
Not yet recruiting
Location
CH Bois Abbaye-Hesbaye
Seraing, Belgium, 4100
Status
Not yet recruiting
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Apr 2017 - Dec 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Patients who meet ALL the following criteria can be enrolled: • Male or female aged at least 18 years. • With a diagnosis of moderate-to-severe chronic plaque psoriasis. As per Belgian National Institute for Health and Disability Insurance (NIHDI), moderate-to-severe plaque psoriasis in adult patients is defined by a Body Surface Area (BSA) > 10% or aPsoriasis Area and Severity Index (PASI) > 10. • For whom the treating dermatologist has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria • Able to follow the instructions of the study. • Having signed an Informed Consent Form (ICF)
    Exclusion Criteria:
    Patients who meet AT LEAST one of the following exclusion criteria will be excluded: • Patients who have received apremilast > 4 weeks prior to the enrolment visit. • Women who are pregnant, breastfeeding or planning on becoming pregnant. • Non-menopausal women who are not using an adequate contraception method. • Patients with hypersensitivity to apremilast or to one of its excipients.