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Completed

NCT Number: NCT03757013

A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.

REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Private Practice, Amiens, Amiens, France

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About this study

Eligible patients will be identified and invited to enroll from approximately 100 dermatologists in France practicing in public hospitals (or private clinics) or private practice. Patients will be followed over 12 months after initiation of apremilast or until discontinuation of apremilast whatever the earlier. Given the observational nature of the study, apremilast dosing and duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice. 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 dermatologist every 6 months. In this study, patients will be followed up at most 12 months after apremilast initiation.

During this study, it is expected to collect data at inclusion (enrolment visit) and around 6 months and 12 months after apremilast initiation, on electronic case report forms (eCRF) by the dermatologist after performing a visit around 6 and 12 months to evaluate the treatment response following the apremilast initiation.

Due to the observational nature of the study, the study protocol does not require any specific tests or additional examinations. All assessments will be recorded in the electronic case report form (eCRF) according to the normal practice of the treating dermatologist. Self-questionnaires will be filled by the patient when visiting his/her dermatologist.

Total duration of the study is 2 years and 6 months, which includes an enrollment period of 1 year and 6 months and a follow up period of up to 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged at least 18 years
  • Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis
  • For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy)
  • Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study
  • Patient literate and willing to fill in questionnaires
  • Non-opposition form signed by the investigator indicating that the patient received information about the study, and orally agreed.

Exclusion criteria

  • Patient who refuses to participate in the study or is unable to give his/her oral consent
  • Patient having participated in an interventional study in the last 30 days

Treatment and study plan

Apremilast

Drug

Apremilast

Primary outcomes

  1. Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.

    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.

Secondary outcomes

  1. Proportion of subjects with PBI-S (range 0-4) 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.

  2. 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

  3. Adherence Rate

    Time frame: Up to 12 months

    The adherence rate will be defined as the percentage of patients pursuing the treatment with apremilast at 12 months after the initiation of apremilast.. The calculation will take into account the patients having started and discontinued apremilast within 4 weeks before the enrolment visit.

  4. Percentage of patients substituting apremilast

    Time frame: Up to 24 months

    The percentage of patients substituting apremilast by a biologic will be estimated by the Kaplan Meier method. The date of origin will be defined as the date apremilast has been started.

  5. Dermatology Life Quality Index (DLQI)

    Time frame: Up to 24 months

    DLQ is a 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. The recall period is 7 days. 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.

  6. Proportion of patients with DLQI ≤ 5

    Time frame: Up to 24 months

    DLQ is a 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. The recall period is 7 days. 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.

  7. Proportion of patients achieving DLQI 0/1

    Time frame: Up to 24 months

    DLQ is a 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. The recall period is 7 days. 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.

  8. Change in DLQI score from M0 to M6 and M12

    Time frame: Up to 12 months

    DLQ is a 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. The recall period is 7 days. 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.

  9. Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12

    Time frame: Up to 12 months

    DLQ is a 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. The recall period is 7 days. 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.

  10. Treatment Satisfaction Questionnaire for Medication (TSQM9)

    Time frame: Up to 24 months

    TSQM-9 is a 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.

  11. Proportion of patients with sPGA 0 or 1

    Time frame: Up to 24 months

    sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.

  12. Change in sPGA from baseline to M6 and M12

    Time frame: Up to 12 months

    sPGA static physician global assessment is defined as single-item-5-point categorized scale reflecting the physician's assessment of psoriasis severity. This scale ranges from 0 to 4.

  13. Percentage of BSA (%BSA) involved at M0, M6, M12

    Time frame: Up to 12 months

    BSA is the measurement of the body area involved in relation to the whole body surface

  14. Change in % BSA from M0 to M6, M12

    Time frame: Up to 12 months

    BSA is the measurement of the body area involved in relation to the whole body surface

  15. Psoriasis Area Severity Index (PASI) at M0, M6, M12

    Time frame: Up to 12 months

    PASI is a 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

  16. Change in PASI from M0 to M6, M12

    Time frame: Up to 12 months

    PASI is a 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

  17. Proportion of patients achieving PASI50 at M6, M12

    Time frame: Up to 12 months

    PASI is a 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

  18. Proportion of patients achieving PASI75 at M6, M12.

    Time frame: Up to 12 months

    PASI is a 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

  19. Adverse Events (AEs)

    Time frame: Up to 24 months

    Number of participants with adverse events

  20. Duration of disease

    Time frame: Baseline

    Duration of disease will be defined as the length of time the disease has been present, indication by months of years.

  21. Number of areas of plaque psoriasis

    Time frame: Baseline

    The number of area of plaque psoriasis will be defined by the number of area observed by the Investigator

  22. Type of chronic psoriasis involved

    Time frame: Baseline

    Types if chronic psoriasis, scalp, palmoplantar, genital

  23. The number of lines of previous systemic treatments

    Time frame: Baseline

    Number of lines of previous systemic treatments will be described by one line, two lines

  24. Type of systemic therapy previously administered

    Time frame: Baseline

    The type of systemic therapies includes corticosteroids, topical, other classification of medications

  25. Duration of previous chronic psoriasis treatment

    Time frame: Baseline

    The duration of previous treatment will be described in months, years.

  26. Number of motivations of the prescription of apremilast

    Time frame: Up to 24 months

    Motivations will be described by the number of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.

  27. Percentage of motivations of the prescription of apremilast

    Time frame: Up to 24 months

    Motivations will be described by the percentage of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France

Acronym: REALIZE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2018
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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