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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 : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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).


Condition or disease Intervention/treatment
Psoriasis Drug: Apremilast

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, which includes an enrollment period of 1 year and a follow up period of up to 1 year.


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : March 26, 2019
Estimated Study Completion Date : September 26, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
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).
Drug: Apremilast
Apremilast




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757013


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
France
Private Practice, Amiens Recruiting
Amiens, France, 80000
Private Practice, Auch Recruiting
Auch, France, 32000
Private Practice, Bordeaux Recruiting
Bordeaux, France, 33000
Private Practice, Bègles Recruiting
Bègles, France, 33130
Private Practice, Caen Recruiting
Caen, France, 14000
Private Practice, Chamalières Recruiting
Chamalières, France, 63400
Private Practice, Charleville Mezières Recruiting
Charleville Mezières, France, 08000
Private Practice, Chartres Recruiting
Chartres, France, 28000
Private Practice 2, Dijon Recruiting
Dijon, France, 21000
Private Practice, Dijon Recruiting
Dijon, France, 21000
Private Practice 2, Joue les Tours Recruiting
Joue les Tours, France, 37300
Private Practice 3, Joue les Tours Recruiting
Joue les Tours, France, 37300
Private Practice, Joue les Tours Recruiting
Joue les Tours, France, 37300
Private Practice, L'Union Recruiting
L'Union, France, 31240
Private Practice, La Varenne Saint Hilaire Recruiting
La Varenne Saint Hilaire, France, 94210
Private Practice, Laval Recruiting
Laval, France, 53000
Private Practice, Le Mans Recruiting
Le Mans, France, 72000
Private Practice, Le-Bourget-du-Lac Recruiting
Le-Bourget-du-Lac, France, 73370
Private Practice, Luce Recruiting
Luce, France, 28110
Private Practice, Lyon Recruiting
Lyon, France, 69002
Private Practice 2, Lyon Recruiting
Lyon, France, 69006
Private Practice 3, Lyon Recruiting
Lyon, France, 69008
Private Practice 4, Lyon Recruiting
Lyon, France, 69008
Private Practice, Martigues Recruiting
Martigues, France, 13500
Private Practice, Metz Tessy Recruiting
Metz Tessy, France, 74370
Private Practice, Nevers Recruiting
Nevers, France, 58000
Private Practice, Paris Recruiting
Paris, France, 75005
Private Practice 2, Paris Recruiting
Paris, France, 75006
Private Practice, Pontoise Recruiting
Pontoise, France, 95300
Private Practice, Saint-Etienne Recruiting
Saint-Etienne, France, 42000
Private Practice, Sainte Maxime Recruiting
Sainte Maxime, France, 83120
Private Practice, Sanary sur Mer Recruiting
Sanary sur Mer, France, 83110
Private Practice, Toulon Recruiting
Toulon, France, 83000
Private Practice, Toulouse Recruiting
Toulouse, France, 31000
Private Practice, Vannes Recruiting
Vannes, France, 56000
Sponsors and Collaborators
Celgene
Investigators
Study Director: Emmanuel Thibout, MD Celgene Corporation

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03757013     History of Changes
Other Study ID Numbers: CC-10004-PSOR-021
U1111-1218-9791 ( Registry Identifier: WHO )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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

Keywords provided by Celgene:
Plaque Psoriasis
Apremilast
France
CC-10004

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents