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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)

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ClinicalTrials.gov Identifier: NCT03757013
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date September 25, 2018
First Posted Date November 28, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date September 25, 2018
Estimated Primary Completion Date June 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2018)
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Adverse Events (AEs) [ Time Frame: Up to 24 months ]
    Number of participants with adverse events
  • 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.
  • 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
  • Type of chronic psoriasis involved [ Time Frame: Baseline ]
    Types if chronic psoriasis, scalp, palmoplantar, genital
  • 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
  • Type of systemic therapy previously administered [ Time Frame: Baseline ]
    The type of systemic therapies includes corticosteroids, topical, other classification of medications
  • Duration of previous chronic psoriasis treatment [ Time Frame: Baseline ]
    The duration of previous treatment will be described in months, years.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official 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
Brief Summary

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).

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

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.

All eligible patients will be included in the safety population in consecutive order based on the date of the non-opposition form.

However, only patients who have completed 6 (± 1) months of treatment will be included in the reference analysis population

Condition Psoriasis
Intervention Drug: Apremilast
Apremilast
Study Groups/Cohorts Patients treated with Apremilast
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).
Intervention: Drug: Apremilast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 21, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 24, 2021
Estimated Primary Completion Date June 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03757013
Other Study ID Numbers CC-10004-PSOR-021
U1111-1218-9791 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date June 2020