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
2 other identifiers
observational
453
1 country
93
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedStudy Start
First participant enrolled
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
November 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2021
CompletedDecember 3, 2021
December 1, 2021
2.8 years
September 25, 2018
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (27)
Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation
Up to 6 months
Proportion of patients with PBI-S=4 at 6 months after apremilast initiation
Up to 6 months
Adherence Rate
Up to 12 months
Percentage of patients substituting apremilast
Up to 24 months
Dermatology Life Quality Index (DLQI)
Up to 24 months
- +22 more secondary outcomes
Study Arms (1)
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).
Interventions
Eligibility Criteria
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
You may qualify if:
- 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 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (93)
Private Practice, Amiens
Amiens, 80000, France
Saint-Joseph Clinic, Angouleme
Angoulême, 16000, France
Private Practice, Antibes
Antibes, 06600, France
Private Practice 2, Antony
Antony, 92160, France
Private Practice 2, Arcachon
Arcachon, 33120, France
Private Practice, Argenteuil
Argenteuil, 95100, France
Private Practice, Aubière
Aubière, 63170, France
Private Practice, Auch
Auch, 32000, France
Auxerre Hospital
Auxerre, 89000, France
Henri Duffaut Hospital
Avignon, 84902, France
Private Practice, Besançon
Besançon, 25000, France
Reims-Bezannes Polyclinic 2
Bezannes, 51430, France
Reims-Bezannes Polyclinic 3
Bezannes, 51430, France
Reims-Bezannes Polyclinic
Bezannes, 51430, France
Private Practice, Bègles
Bègles, 33130, France
Private Practice, Biarritz
Biarritz, 64200, France
Private Practice, Bordeaux
Bordeaux, 33000, France
Docteur Duchenne Hospital 2
Boulogne-sur-Mer, 62321, France
Docteur Duchenne Hospital
Boulogne-sur-Mer, 62321, France
Private Practice 2, Caen
Caen, 14000, France
Private Practice 3, Caen
Caen, 14000, France
Private Practice, Caen
Caen, 14000, France
Private Practice, Cannes
Cannes, 06400, France
Private Practice, Chamalières
Chamalières, 63400, France
Métropole Savoie Hospital
Chambéry, 73000, France
Trousseau Hospital
Chambray-lès-Tours, 37171, France
Private Practice 2, Chartres
Chartres, 28000, France
Private Practice, Chartres
Chartres, 28000, France
Private Practice 2, Chalons-en-Champagne
Châlons-en-Champagne, 51000, France
Private Practice, Chalons-en-Champagne
Châlons-en-Champagne, 51000, France
Chalons-en-Champagne Hospital
Châlons-en-Champagne, 51005, France
New Sud Francilien Hospital
Corbeil-Essonnes, 91100, France
GH de Dax, Dax
Dax, 40107, France
Private Practice 2, Dijon
Dijon, 21000, France
Private Practice 3, Dijon
Dijon, 21000, France
Private Practice, Dijon
Dijon, 21000, France
Private Practice, Dole
Dole, 39100, France
Victor Jousselin Hospital
Dreux, 28102, France
Private Practice, Essey-les-Nancy
Essey-lès-Nancy, 54270, France
Emile Durkheim Hospital - Saint Jean Health Center
Épinal, 88021, France
Golfe de St-Tropez Clinic
Gassin, 83580, France
Private Practice 2, Joue les Tours
Joué-lès-Tours, 37300, France
Private Practice 3, Joue les Tours
Joué-lès-Tours, 37300, France
Private Practice, Joue les Tours
Joué-lès-Tours, 37300, France
Private Practice, L'Union
L'Union, 31240, France
Private Practice 2, La Teste-de-Buch
La Teste-de-Buch, 33260, France
Private Practice, La Teste-de-Buch
La Teste-de-Buch, 33260, France
Private Practice, La Valette du Var
La Valette-du-Var, 83160, France
Private Practice, La Varenne Saint Hilaire
La Varenne-Saint-Hilaire, 94210, France
Private Practice 2, Laval
Laval, 53000, France
Private Practice, Laval
Laval, 53000, France
Private Practice, Le-Bourget-du-Lac
Le Bourget-du-Lac, 73370, France
Private Practice, Le Mans
Le Mans, 72000, France
Mans Hospital 2
Le Mans, 72037, France
Mans Hospital
Le Mans, 72037, France
Private Practice, Lille
Lille, 59000, France
Private Practice 2, Luce
Lucé, 28110, France
Private Practice, Luce
Lucé, 28110, France
Private Practice, Lyon
Lyon, 69002, France
Edouard Herriot Hospital
Lyon, 69003, France
Private Practice 2, Lyon
Lyon, 69006, France
Private Practice 4, Lyon
Lyon, 69008, France
Private Practice, Martigues
Martigues, 13500, France
Annecy Genevois Hospital, Metz Tessy
Metz-Tessy, 74370, France
Private Practice, Meudon-la-Forêt
Meudon-la-Forêt, 92360, France
Private Practice, Muret
Muret, 31600, France
Hotel Dieu Hospital, Dermatologic Clinic
Nantes, 44093, France
Private Practice, Narbonne
Narbonne, 11100, France
Private Practice, Nevers
Nevers, 58000, France
Private Practice 2, Nice
Nice, 06000, France
Private Practice 3, Nice
Nice, 06000, France
Private Practice, Nogent-Le-Rotrou
Nogent-le-Rotrou, 28400, France
Private Practice, Orléans
Orléans, 45000, France
Private Practice, Paris
Paris, 75005, France
Private Practice 2, Paris
Paris, 75006, France
Private Practice 3, Paris
Paris, 75008, France
Private Practice 4, Paris
Paris, 75009, France
Private Practice 5, Paris
Paris, 75010, France
Private Practice, Pontarlier
Pontarlier, 25300, France
Private Practice, Pontoise
Pontoise, 95300, France
Private Practice, Quimper
Quimper, 29000, France
CHI de Cornouaille - Laennec
Quimper, 29107, France
Mathilde II Clinic
Rouen, 76100, France
Private Practice, Saint-Etienne
Saint-Etienne, 42000, France
Saint-Etienne Hospital
Saint-Priest-en-Jarez, 42277, France
Private Practice, Torcy
Torcy, 77200, France
BCRM Toulon - HIA Saint-Anne
Toulon, 83800, France
Private Practice, Toulouse
Toulouse, 31000, France
Nord Franche-Comté Hospital
Trévenans, 90400, France
Valence Hospital 2
Valence, 26953, France
Valence Hospital 3
Valence, 26953, France
Valence Hospital
Valence, 26953, France
Jacques Lacarin Hospital
Vichy, 03201, France
Related Publications (1)
Jullien D, Richard MA, Halioua B, Bessette C, Derancourt C, Bouloc A. The Needs of Patients with Psoriasis and Benefits of Apremilast in French Clinical Practice: Results from the Observational REALIZE Study. Dermatol Ther (Heidelb). 2023 Jun;13(6):1361-1376. doi: 10.1007/s13555-023-00933-z. Epub 2023 May 19.
PMID: 37204608DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
November 28, 2018
Study Start
September 25, 2018
Primary Completion
July 21, 2021
Study Completion
September 10, 2021
Last Updated
December 3, 2021
Record last verified: 2021-12