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)

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: 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 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
• Enrollment (Actual): 453

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Private Practice, Amiens
  • Angouleme, France, 16000
    • Saint-Joseph Clinic, Angouleme
  • Antibes, France, 06600
    • Private Practice, Antibes
  • Antony, France, 92160
    • Private Practice 2, Antony
  • Arcachon, France, 33120
    • Private Practice 2, Arcachon
  • Argenteuil, France, 95100
    • Private Practice, Argenteuil
  • Aubière, France, 63170
    • Private Practice, Aubière
  • Auch, France, 32000
    • Private Practice, Auch
  • Auxerre, France, 89000
    • Auxerre Hospital
  • Avignon Cedex 9, France, 84902
    • Henri Duffaut Hospital
  • Besançon, France, 25000
    • Private Practice, Besançon
  • Bezannes, France, 51430
    • Reims-Bezannes Polyclinic 2
  • Bezannes, France, 51430
    • Reims-Bezannes Polyclinic 3
  • Bezannes, France, 51430
    • Reims-Bezannes Polyclinic
  • Biarritz, France, 64200
    • Private Practice, Biarritz
  • Bordeaux, France, 33000
    • Private Practice, Bordeaux
  • Boulogne-sur-Mer, France, 62321
    • Docteur Duchenne Hospital 2
  • Boulogne-sur-Mer, France, 62321
    • Docteur Duchenne Hospital
  • Bègles, France, 33130
    • Private Practice, Bègles
  • Caen, France, 14000
    • Private Practice 2, Caen
  • Caen, France, 14000
    • Private Practice 3, Caen
  • Caen, France, 14000
    • Private Practice, Caen
  • Cannes, France, 06400
    • Private Practice, Cannes
  • Chalons-en -Champagne, France, 51000
    • Private Practice 2, Chalons-en-Champagne
  • Chalons-en-Champagne, France, 51000
    • Private Practice, Chalons-en-Champagne
  • Chalons-en-Champagne, France, 51005
    • Chalons-en-Champagne Hospital
  • Chamalières, France, 63400
    • Private Practice, Chamalières
  • Chambray-Les-Tours Cedex, France, 37171
    • Trousseau Hospital
  • Chambéry, France, 73000
    • Métropole Savoie Hospital
  • Chartres, France, 28000
    • Private Practice 2, Chartres
  • Chartres, France, 28000
    • Private Practice, Chartres
  • Corbeil Essonnes, France, 91100
    • New Sud Francilien Hospital
  • Dax, France, 40107
    • GH de Dax, Dax
  • Dijon, France, 21000
    • Private Practice 2, Dijon
  • Dijon, France, 21000
    • Private Practice 3, Dijon
  • Dijon, France, 21000
    • Private Practice, Dijon
  • Dole, France, 39100
    • Private Practice, Dole
  • Dreux, France, 28102
    • Victor Jousselin Hospital
  • Epinal Cedex, France, 88021
    • Emile Durkheim Hospital - Saint Jean Health Center
  • Essey-les-Nancy, France, 54270
    • Private Practice, Essey-les-Nancy
  • Gassin, France, 83580
    • Golfe de St-Tropez Clinic
  • Joue les Tours, France, 37300
    • Private Practice 2, Joue les Tours
  • Joue les Tours, France, 37300
    • Private Practice 3, Joue les Tours
  • Joue les Tours, France, 37300
    • Private Practice, Joue les Tours
  • L'Union, France, 31240
    • Private Practice, L'Union
  • La Teste-de-Buch, France, 33260
    • Private Practice 2, La Teste-de-Buch
  • La Teste-de-Buch, France, 33260
    • Private Practice, La Teste-de-Buch
  • La Valette du Var, France, 83160
    • Private Practice, La Valette du Var
  • La Varenne Saint Hilaire, France, 94210
    • Private Practice, La Varenne Saint Hilaire
  • Laval, France, 53000
    • Private Practice 2, Laval
  • Laval, France, 53000
    • Private Practice, Laval
  • Le Mans, France, 72000
    • Private Practice, Le Mans
  • Le Mans, France, 72037
    • Mans Hospital 2
  • Le Mans, France, 72037
    • Mans Hospital
  • Le-Bourget-du-Lac, France, 73370
    • Private Practice, Le-Bourget-du-Lac
  • Lille, France, 59000
    • Private Practice, Lille
  • Luce, France, 28110
    • Private Practice 2, Luce
  • Luce, France, 28110
    • Private Practice, Luce
  • Lyon, France, 69003
    • Edouard Herriot Hospital
  • Lyon, France, 69002
    • Private Practice, Lyon
  • Lyon, France, 69006
    • Private Practice 2, Lyon
  • Lyon, France, 69008
    • Private Practice 4, Lyon
  • Martigues, France, 13500
    • Private Practice, Martigues
  • Metz Tessy, France, 74370
    • Annecy Genevois Hospital, Metz Tessy
  • Meudon-la-Forêt, France, 92360
    • Private Practice, Meudon-la-Forêt
  • Muret, France, 31600
    • Private Practice, Muret
  • Nantes, France, 44093
    • Hotel Dieu Hospital, Dermatologic Clinic
  • Narbonne, France, 11100
    • Private Practice, Narbonne
  • Nevers, France, 58000
    • Private Practice, Nevers
  • Nice, France, 06000
    • Private Practice 2, Nice
  • Nice, France, 06000
    • Private Practice 3, Nice
  • Nogent-Le-Rotrou, France, 28400
    • Private Practice, Nogent-Le-Rotrou
  • Orléans, France, 45000
    • Private Practice, Orléans
  • Paris, France, 75005
    • Private Practice, Paris
  • Paris, France, 75006
    • Private Practice 2, Paris
  • Paris, France, 75008
    • Private Practice 3, Paris
  • Paris, France, 75009
    • Private Practice 4, Paris
  • Paris, France, 75010
    • Private Practice 5, Paris
  • Pontarlier, France, 25300
    • Private Practice, Pontarlier
  • Pontoise, France, 95300
    • Private Practice, Pontoise
  • Quimper, France, 29000
    • Private Practice, Quimper
  • Quimper, France, 29107
    • CHI de Cornouaille - Laennec
  • Rouen, France, 76100
    • Mathilde II Clinic
  • Saint-Etienne, France, 42000
    • Private Practice, Saint-Etienne
  • St Priest en Jarez, France, 42277
    • Saint-Etienne Hospital
  • Torcy, France, 77200
    • Private Practice, Torcy
  • Toulon Cedex 9, France, 83800
    • BCRM Toulon - HIA Saint-Anne
  • Toulouse, France, 31000
    • Private Practice, Toulouse
  • Trevenans, France, 90400
    • Nord Franche-Comté Hospital
  • Valence, France, 26953
    • Valence Hospital 2
  • Valence, France, 26953
    • Valence Hospital 3
  • Valence, France, 26953
    • Valence Hospital
  • Vichy, France, 03201
    • Jacques Lacarin Hospital

Participation Criteria

Eligibility Criteria

• 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

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation	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
Proportion of patients with PBI-S=4 at 6 months after apremilast initiation	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
Adherence Rate	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.	Up to 12 months
Percentage of patients substituting apremilast	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.	Up to 24 months
Dermatology Life Quality Index (DLQI)	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.	Up to 24 months
Proportion of patients with DLQI ≤ 5	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.	Up to 24 months
Proportion of patients achieving DLQI 0/1	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.	Up to 24 months
Change in DLQI score from M0 to M6 and M12	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.	Up to 12 months
Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12	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.	Up to 12 months
Treatment Satisfaction Questionnaire for Medication (TSQM9)	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.	Up to 24 months
Proportion of patients with sPGA 0 or 1	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.	Up to 24 months
Change in sPGA from baseline to M6 and M12	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.	Up to 12 months
Percentage of BSA (%BSA) involved at M0, M6, M12	BSA is the measurement of the body area involved in relation to the whole body surface	Up to 12 months
Change in % BSA from M0 to M6, M12	BSA is the measurement of the body area involved in relation to the whole body surface	Up to 12 months
Psoriasis Area Severity Index (PASI) at M0, M6, M12	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	Up to 12 months
Change in PASI from M0 to M6, M12	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	Up to 12 months
Proportion of patients achieving PASI50 at M6, M12	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	Up to 12 months
Proportion of patients achieving PASI75 at M6, M12.	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	Up to 12 months
Adverse Events (AEs)	Number of participants with adverse events	Up to 24 months
Duration of disease	Duration of disease will be defined as the length of time the disease has been present, indication by months of years.	Baseline
Number of areas of plaque psoriasis	The number of area of plaque psoriasis will be defined by the number of area observed by the Investigator	Baseline
Type of chronic psoriasis involved	Types if chronic psoriasis, scalp, palmoplantar, genital	Baseline
The number of lines of previous systemic treatments	Number of lines of previous systemic treatments will be described by one line, two lines	Baseline
Type of systemic therapy previously administered	The type of systemic therapies includes corticosteroids, topical, other classification of medications	Baseline
Duration of previous chronic psoriasis treatment	The duration of previous treatment will be described in months, years.	Baseline
Number of motivations of the prescription of apremilast	Motivations will be described by the number of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.	Up to 24 months
Percentage of motivations of the prescription of apremilast	Motivations will be described by the percentage of patients with lack of response or intolerance or patient's dissatisfaction regarding the previous treatment.	Up to 24 months

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2018
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Plaque Psoriasis; CC-10004; Apremilast; France
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PSOR-021; U1111-1218-9791 (Registry Identifier: WHO)

Drug and device information, study documents

• 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