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
NCT ID: NCT03757013
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
453 participants
OBSERVATIONAL
2018-09-25
2021-09-10
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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).
Apremilast
Apremilast
Interventions
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Apremilast
Apremilast
Eligibility Criteria
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Inclusion Criteria
* 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 having participated in an interventional study in the last 30 days
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Private Practice, Amiens
Amiens, , France
Saint-Joseph Clinic, Angouleme
Angoulême, , France
Private Practice, Antibes
Antibes, , France
Private Practice 2, Antony
Antony, , France
Private Practice 2, Arcachon
Arcachon, , France
Private Practice, Argenteuil
Argenteuil, , France
Private Practice, Aubière
Aubière, , France
Private Practice, Auch
Auch, , France
Auxerre Hospital
Auxerre, , France
Henri Duffaut Hospital
Avignon, , France
Private Practice, Besançon
Besançon, , France
Reims-Bezannes Polyclinic 2
Bezannes, , France
Reims-Bezannes Polyclinic 3
Bezannes, , France
Reims-Bezannes Polyclinic
Bezannes, , France
Private Practice, Bègles
Bègles, , France
Private Practice, Biarritz
Biarritz, , France
Private Practice, Bordeaux
Bordeaux, , France
Docteur Duchenne Hospital 2
Boulogne-sur-Mer, , France
Docteur Duchenne Hospital
Boulogne-sur-Mer, , France
Private Practice 2, Caen
Caen, , France
Private Practice 3, Caen
Caen, , France
Private Practice, Caen
Caen, , France
Private Practice, Cannes
Cannes, , France
Private Practice, Chamalières
Chamalières, , France
Métropole Savoie Hospital
Chambéry, , France
Trousseau Hospital
Chambray-lès-Tours, , France
Private Practice 2, Chartres
Chartres, , France
Private Practice, Chartres
Chartres, , France
Private Practice 2, Chalons-en-Champagne
Châlons-en-Champagne, , France
Private Practice, Chalons-en-Champagne
Châlons-en-Champagne, , France
Chalons-en-Champagne Hospital
Châlons-en-Champagne, , France
New Sud Francilien Hospital
Corbeil-Essonnes, , France
GH de Dax, Dax
Dax, , France
Private Practice 2, Dijon
Dijon, , France
Private Practice 3, Dijon
Dijon, , France
Private Practice, Dijon
Dijon, , France
Private Practice, Dole
Dole, , France
Victor Jousselin Hospital
Dreux, , France
Private Practice, Essey-les-Nancy
Essey-lès-Nancy, , France
Emile Durkheim Hospital - Saint Jean Health Center
Épinal, , France
Golfe de St-Tropez Clinic
Gassin, , France
Private Practice 2, Joue les Tours
Joué-lès-Tours, , France
Private Practice 3, Joue les Tours
Joué-lès-Tours, , France
Private Practice, Joue les Tours
Joué-lès-Tours, , France
Private Practice, L'Union
L'Union, , France
Private Practice 2, La Teste-de-Buch
La Teste-de-Buch, , France
Private Practice, La Teste-de-Buch
La Teste-de-Buch, , France
Private Practice, La Valette du Var
La Valette-du-Var, , France
Private Practice, La Varenne Saint Hilaire
La Varenne-Saint-Hilaire, , France
Private Practice 2, Laval
Laval, , France
Private Practice, Laval
Laval, , France
Private Practice, Le-Bourget-du-Lac
Le Bourget-du-Lac, , France
Private Practice, Le Mans
Le Mans, , France
Mans Hospital 2
Le Mans, , France
Mans Hospital
Le Mans, , France
Private Practice, Lille
Lille, , France
Private Practice 2, Luce
Lucé, , France
Private Practice, Luce
Lucé, , France
Private Practice, Lyon
Lyon, , France
Edouard Herriot Hospital
Lyon, , France
Private Practice 2, Lyon
Lyon, , France
Private Practice 4, Lyon
Lyon, , France
Private Practice, Martigues
Martigues, , France
Annecy Genevois Hospital, Metz Tessy
Metz-Tessy, , France
Private Practice, Meudon-la-Forêt
Meudon-la-Forêt, , France
Private Practice, Muret
Muret, , France
Hotel Dieu Hospital, Dermatologic Clinic
Nantes, , France
Private Practice, Narbonne
Narbonne, , France
Private Practice, Nevers
Nevers, , France
Private Practice 2, Nice
Nice, , France
Private Practice 3, Nice
Nice, , France
Private Practice, Nogent-Le-Rotrou
Nogent-le-Rotrou, , France
Private Practice, Orléans
Orléans, , France
Private Practice, Paris
Paris, , France
Private Practice 2, Paris
Paris, , France
Private Practice 3, Paris
Paris, , France
Private Practice 4, Paris
Paris, , France
Private Practice 5, Paris
Paris, , France
Private Practice, Pontarlier
Pontarlier, , France
Private Practice, Pontoise
Pontoise, , France
Private Practice, Quimper
Quimper, , France
CHI de Cornouaille - Laennec
Quimper, , France
Mathilde II Clinic
Rouen, , France
Private Practice, Saint-Etienne
Saint-Etienne, , France
Saint-Etienne Hospital
Saint-Priest-en-Jarez, , France
Private Practice, Torcy
Torcy, , France
BCRM Toulon - HIA Saint-Anne
Toulon, , France
Private Practice, Toulouse
Toulouse, , France
Nord Franche-Comté Hospital
Trévenans, , France
Valence Hospital 2
Valence, , France
Valence Hospital 3
Valence, , France
Valence Hospital
Valence, , France
Jacques Lacarin Hospital
Vichy, , France
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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U1111-1218-9791
Identifier Type: REGISTRY
Identifier Source: secondary_id
CC-10004-PSOR-021
Identifier Type: -
Identifier Source: org_study_id