Clinical trial NCT03097003: A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
Official title: An Observational Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Proriasis
Real-life management
Observational
Otezla
CC-10004
Apremilast
Belgium
OTELO
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with moderate-to-severe plaque psoriasis visiting dermatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria.

Patients may be enrolled into the study up to 4 weeks after commencing the treatment with apremilast. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.

Brief summary: 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.

Detailed description: Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologists every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Patient data will be collected until 31st December 2018. Assuming a recruitment phase of 18-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date. During the first months of the study, the recruitment rate has been slower than expected. Therefore, it has been decided in October 2017 to increase the period of recruitment to 18 months in order to have enough evaluable patients to keep the accuracy required for the statistical analysis.

During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating dermatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.

All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an eCRF. Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.

During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.

Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.

Eligibility 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.

Primary outcomes:
measure: 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 outcomes:
measure: Characteristics of the patients treated with apremilast
timeFrame: Baseline
measure: Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation
timeFrame: Up to 6 Months
measure: PBI-S outcome score after apremilast initiation
timeFrame: up to 18 months
measure: Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation
timeFrame: up to 6 months
measure: Change from baseline in the PtGA after apremilast initiation
timeFrame: up to 18 months
measure: Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation.
timeFrame: Up to 6 Months
measure: Change from baseline in the DLQI score after apremilast initiation
timeFrame: up to 18 months
measure: Change from baseline in the psoriasis symptomatology
timeFrame: up to 18 months
measure: Change from baseline in the patient-reported treatment satisfaction (TSQM-9)
timeFrame: up to 18 months
measure: 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
measure: Change from baseline in the disease activity scores in terms of Body Surface Area (BSA)
timeFrame: up to 18 months
measure: Change from baseline in the disease activity scores in terms of PASI
timeFrame: up to 18 months
measure: Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment
timeFrame: Up to 18 Months
measure: Rate of discontinuation of apremilast treatment within 6 months after initiation
timeFrame: Up to 6 months
measure: Adverse Events (AEs)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussels
country: Belgium
facility: CHU St Pierre
city: Brussels
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Brussels
country: Belgium
facility: Clin Univ de Bxl Hôpital Erasme
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Geel
country: Belgium
facility: Private Practice Geel
city: Genk
country: Belgium
facility: Private Practice Genk
city: Gent
country: Belgium
facility: AZ Sint Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Herstal
country: Belgium
facility: Clinique André Renard d'Herstal
city: Lede
country: Belgium
facility: Private Practice Lede
city: Leuven
country: Belgium
facility: UZ Leuven Sint Rafael
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Loverval
country: Belgium
facility: GHdC - site IMTR
city: Malgegem
country: Belgium
facility: Dermatologie Maldegem
city: Mons
country: Belgium
facility: Private Practice Mons
city: Namur
country: Belgium
facility: Private Practice Namur
city: Namur
country: Belgium
facility: Ste Elisabeth - Namur
city: Seraing
country: Belgium
facility: CH Bois Abbaye-Hesbaye
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Ghislain PD, Lambert J, Lam Hoai XL, Hillary T, Roquet-Gravy PP, de la Brassinne M, Segaert S. Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study. Adv Ther. 2022 Feb;39(2):1068-1080. doi: 10.1007/s12325-021-01981-7. Epub 2022 Jan 3.