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

April 24, 2020 updated by: Amgen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1000
        • CHU St Pierre
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Brussels, Belgium, 1020
        • CHU Brugmann (Victor Horta)
      • Brussels, Belgium, 1070
        • Clin Univ de Bxl Hôpital Erasme
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Geel, Belgium, 2440
        • Private Practice Geel
      • Genk, Belgium, 3600
        • Private Practice Genk
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • AZ Sint Lucas
      • Godinne, Belgium, 5530
        • CHU UCL Mont-Godinne
      • Herstal, Belgium, 4040
        • Clinique André Renard d'Herstal
      • Lede, Belgium, 9340
        • Private Practice Lede
      • Leuven, Belgium, 3000
        • UZ Leuven Sint Rafael
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Loverval, Belgium, 6280
        • GHdC - site IMTR
      • Malgegem, Belgium, 9990
        • Dermatologie Maldegem
      • Mons, Belgium, 7000
        • Private Practice Mons
      • Namur, Belgium, 5000
        • Private Practice Namur
      • Namur, Belgium, 5000
        • Ste Elisabeth - Namur
      • Seraing, Belgium, 4100
        • CH Bois Abbaye-Hesbaye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Use of Apremilast in patient with plaque psoriasis
Psoriasis patients treated with Otezla® (Apremilast) in Belgium
Drug: Apremilast
Psoriasis patients treated with Otezla® (Apremilast) in Belgium

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
Up to 6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characteristics of the patients treated with apremilast
Time Frame: Baseline
The patients treated with Apremilast will be described according to the following characteristics: demographics (age, gender, weight, height, and ethnicity), professional status, lifestyle habits, medical history (including psoriasis treatment history), and comorbidities
Baseline
Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation
Time Frame: Up to 6 Months
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
Up to 6 Months
PBI-S outcome score after apremilast initiation
Time Frame: up to 18 months
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
up to 18 months
Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation
Time Frame: up to 6 months
PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)
up to 6 months
Change from baseline in the PtGA after apremilast initiation
Time Frame: up to 18 months
PtGA is defined as single-item 5-point categorised scale reflecting the patient's overall impression of psoriasis severity. This scale ranges from 0 (clear/no psoriasis) to 4 (severe psoriasis)
up to 18 months
Proportion of patients with Dermatology Life Quality Index (DLQI) ≤ 5 at 6 months after apremilast initiation.
Time Frame: Up to 6 Months
DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
Up to 6 Months
Change from baseline in the DLQI score after apremilast initiation
Time Frame: up to 18 months
DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument. It covers a variety of health dimensions, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Each item is graded on a Likert scale of 0-3, which gives an overall score ranging from 0 to 30 where lower scores mean better quality of life.
up to 18 months
Change from baseline in the psoriasis symptomatology
Time Frame: up to 18 months
Psoriasis symptomatology - pruritus, scalp psoriasis, nail psoriasis, skin discomfort/pain, joint pain, fatigue, overall wellbeing. Each symptom will be graded using a 7-grade discrete rating scale
up to 18 months
Change from baseline in the patient-reported treatment satisfaction (TSQM-9)
Time Frame: up to 18 months
TSQM-9 is 9-item validated self-administered questionnaire used to evaluate the patient's overall satisfaction with study treatment. The TSQM-9 consists of 8 items that make up 3 specific scales (effectiveness, side effects, convenience) and one global satisfaction scale. Scale scores are transformed into scores from 0 to 100 with higher scores representing higher satisfaction in that domain.
up to 18 months
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 or PASI 75 at 6 months after apremilast initiation
Time Frame: Up to 6 Months
PASI is common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline
Up to 6 Months
Change from baseline in the disease activity scores in terms of Body Surface Area (BSA)
Time Frame: up to 18 months
BSA is measurement of the body area involved in relation to the whole body surface.
up to 18 months
Change from baseline in the disease activity scores in terms of PASI
Time Frame: up to 18 months
PASI is common clinical tool used to measure the severity and extent of psoriasis. PASI score is a composite score grading the severity of psoriasis in four body regions according to erythema, scaling, and thickness, and the total area of skin affected. The final composite score ranges from 0 to 72, with a higher score indicating a greater severity of psoriasis. PASI 50 and PASI 75 responses were defined as >=50% and >= 75% improvement in overall PASI score when compared to baseline
up to 18 months
Mean duration of apremilast treatment in biologic-naïve patients and in patients having received a previous biological treatment
Time Frame: Up to 18 Months
Time to the stop of the treatment by Apremilast will be calculated as the time interval from the date of apremilast initiation to the date of the apremilast stop
Up to 18 Months
Rate of discontinuation of apremilast treatment within 6 months after initiation
Time Frame: Up to 6 months
Descriptive statistics will be provided for the rate and reasons for discontinuation of treatment within 6 months. This analysis will be performed on safety population and restricted to patients who stop the treatment before the time point to analyse or for which the follow-up is at least so long as the time point to analyse.
Up to 6 months
Adverse Events (AEs)
Time Frame: Up to 18 months
Number of participants with adverse event
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-10004-PSOR-016
  • U1111-1194-1580 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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