Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Apremilast
France
CC-10004
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation
timeFrame: Up to 6 months
measure: Proportion of patients with PBI-S=4 at 6 months after apremilast initiation
timeFrame: Up to 6 months
measure: Adherence Rate
timeFrame: Up to 12 months
measure: Percentage of patients substituting apremilast
timeFrame: Up to 24 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Up to 24 months
measure: Proportion of patients with DLQI ≤ 5
timeFrame: Up to 24 months
measure: Proportion of patients achieving DLQI 0/1
timeFrame: Up to 24 months
measure: Change in DLQI score from M0 to M6 and M12
timeFrame: Up to 12 months
measure: Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12
timeFrame: Up to 12 months
measure: Treatment Satisfaction Questionnaire for Medication (TSQM9)
timeFrame: Up to 24 months
measure: Proportion of patients with sPGA 0 or 1
timeFrame: Up to 24 months
measure: Change in sPGA from baseline to M6 and M12
timeFrame: Up to 12 months
measure: Percentage of BSA (%BSA) involved at M0, M6, M12
timeFrame: Up to 12 months
measure: Change in % BSA from M0 to M6, M12
timeFrame: Up to 12 months
measure: Psoriasis Area Severity Index (PASI) at M0, M6, M12
timeFrame: Up to 12 months
measure: Change in PASI from M0 to M6, M12
timeFrame: Up to 12 months
measure: Proportion of patients achieving PASI50 at M6, M12
timeFrame: Up to 12 months
measure: Proportion of patients achieving PASI75 at M6, M12.
timeFrame: Up to 12 months
measure: Adverse Events (AEs)
timeFrame: Up to 24 months
measure: Duration of disease
timeFrame: Baseline
measure: Number of areas of plaque psoriasis
timeFrame: Baseline
measure: Type of chronic psoriasis involved
timeFrame: Baseline
measure: The number of lines of previous systemic treatments
timeFrame: Baseline
measure: Type of systemic therapy previously administered
timeFrame: Baseline
measure: Duration of previous chronic psoriasis treatment
timeFrame: Baseline
measure: Number of motivations of the prescription of apremilast
timeFrame: Up to 24 months
measure: Percentage of motivations of the prescription of apremilast
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Private Practice, Amiens
city: Angouleme
country: France
facility: Saint-Joseph Clinic, Angouleme
city: Antibes
country: France
facility: Private Practice, Antibes
city: Antony
country: France
facility: Private Practice 2, Antony
city: Arcachon
country: France
facility: Private Practice 2, Arcachon
city: Argenteuil
country: France
facility: Private Practice, Argenteuil
city: Aubière
country: France
facility: Private Practice, Aubière
city: Auch
country: France
facility: Private Practice, Auch
city: Auxerre
country: France
facility: Auxerre Hospital
city: Avignon Cedex 9
country: France
facility: Henri Duffaut Hospital
city: Besançon
country: France
facility: Private Practice, Besançon
city: Bezannes
country: France
facility: Reims-Bezannes Polyclinic 2
city: Bezannes
country: France
facility: Reims-Bezannes Polyclinic 3
city: Bezannes
country: France
facility: Reims-Bezannes Polyclinic
city: Biarritz
country: France
facility: Private Practice, Biarritz
city: Bordeaux
country: France
facility: Private Practice, Bordeaux
city: Boulogne-sur-Mer
country: France
facility: Docteur Duchenne Hospital 2
city: Boulogne-sur-Mer
country: France
facility: Docteur Duchenne Hospital
city: Bègles
country: France
facility: Private Practice, Bègles
city: Caen
country: France
facility: Private Practice 2, Caen
city: Caen
country: France
facility: Private Practice 3, Caen
city: Caen
country: France
facility: Private Practice, Caen
city: Cannes
country: France
facility: Private Practice, Cannes
city: Chalons-en -Champagne
country: France
facility: Private Practice 2, Chalons-en-Champagne
city: Chalons-en-Champagne
country: France
facility: Private Practice, Chalons-en-Champagne
city: Chalons-en-Champagne
country: France
facility: Chalons-en-Champagne Hospital
city: Chamalières
country: France
facility: Private Practice, Chamalières
city: Chambray-Les-Tours Cedex
country: France
facility: Trousseau Hospital
city: Chambéry
country: France
facility: Métropole Savoie Hospital
city: Chartres
country: France
facility: Private Practice 2, Chartres
city: Chartres
country: France
facility: Private Practice, Chartres
city: Corbeil Essonnes
country: France
facility: New Sud Francilien Hospital
city: Dax
country: France
facility: GH de Dax, Dax
city: Dijon
country: France
facility: Private Practice 2, Dijon
city: Dijon
country: France
facility: Private Practice 3, Dijon
city: Dijon
country: France
facility: Private Practice, Dijon
city: Dole
country: France
facility: Private Practice, Dole
city: Dreux
country: France
facility: Victor Jousselin Hospital
city: Epinal Cedex
country: France
facility: Emile Durkheim Hospital - Saint Jean Health Center
city: Essey-les-Nancy
country: France
facility: Private Practice, Essey-les-Nancy
city: Gassin
country: France
facility: Golfe de St-Tropez Clinic
city: Joue les Tours
country: France
facility: Private Practice 2, Joue les Tours
city: Joue les Tours
country: France
facility: Private Practice 3, Joue les Tours
city: Joue les Tours
country: France
facility: Private Practice, Joue les Tours
city: L'Union
country: France
facility: Private Practice, L'Union
city: La Teste-de-Buch
country: France
facility: Private Practice 2, La Teste-de-Buch
city: La Teste-de-Buch
country: France
facility: Private Practice, La Teste-de-Buch
city: La Valette du Var
country: France
facility: Private Practice, La Valette du Var
city: La Varenne Saint Hilaire
country: France
facility: Private Practice, La Varenne Saint Hilaire
city: Laval
country: France
facility: Private Practice 2, Laval
city: Laval
country: France
facility: Private Practice, Laval
city: Le Mans
country: France
facility: Private Practice, Le Mans
city: Le Mans
country: France
facility: Mans Hospital 2
city: Le Mans
country: France
facility: Mans Hospital
city: Le-Bourget-du-Lac
country: France
facility: Private Practice, Le-Bourget-du-Lac
city: Lille
country: France
facility: Private Practice, Lille
city: Luce
country: France
facility: Private Practice 2, Luce
city: Luce
country: France
facility: Private Practice, Luce
city: Lyon
country: France
facility: Private Practice, Lyon
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Private Practice 2, Lyon
city: Lyon
country: France
facility: Private Practice 4, Lyon
city: Martigues
country: France
facility: Private Practice, Martigues
city: Metz Tessy
country: France
facility: Annecy Genevois Hospital, Metz Tessy
city: Meudon-la-Forêt
country: France
facility: Private Practice, Meudon-la-Forêt
city: Muret
country: France
facility: Private Practice, Muret
city: Nantes
country: France
facility: Hotel Dieu Hospital, Dermatologic Clinic
city: Narbonne
country: France
facility: Private Practice, Narbonne
city: Nevers
country: France
facility: Private Practice, Nevers
city: Nice
country: France
facility: Private Practice 2, Nice
city: Nice
country: France
facility: Private Practice 3, Nice
city: Nogent-Le-Rotrou
country: France
facility: Private Practice, Nogent-Le-Rotrou
city: Orléans
country: France
facility: Private Practice, Orléans
city: Paris
country: France
facility: Private Practice, Paris
city: Paris
country: France
facility: Private Practice 2, Paris
city: Paris
country: France
facility: Private Practice 3, Paris
city: Paris
country: France
facility: Private Practice 4, Paris
city: Paris
country: France
facility: Private Practice 5, Paris
city: Pontarlier
country: France
facility: Private Practice, Pontarlier
city: Pontoise
country: France
facility: Private Practice, Pontoise
city: Quimper
country: France
facility: Private Practice, Quimper
city: Quimper
country: France
facility: CHI de Cornouaille - Laennec
city: Rouen
country: France
facility: Mathilde II Clinic
city: Saint-Etienne
country: France
facility: Private Practice, Saint-Etienne
city: St Priest en Jarez
country: France
facility: Saint-Etienne Hospital
city: Torcy
country: France
facility: Private Practice, Torcy
city: Toulon Cedex 9
country: France
facility: BCRM Toulon - HIA Saint-Anne
city: Toulouse
country: France
facility: Private Practice, Toulouse
city: Trevenans
country: France
facility: Nord Franche-Comté Hospital
city: Valence
country: France
facility: Valence Hospital 2
city: Valence
country: France
facility: Valence Hospital 3
city: Valence
country: France
facility: Valence Hospital
city: Vichy
country: France
facility: Jacques Lacarin Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: