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
Study Purpose
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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years and Over |
Gender | All |
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 daysTrial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03757013 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Amgen |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
MD |
Principal Investigator Affiliation | Amgen |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | France |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriasis |
Study Website: | View Trial Website |
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.
Arms
: 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
Drug: - Apremilast
Apremilast
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Private Practice, Amiens
Amiens, , 80000
Status
Recruiting
Address
Saint-Joseph Clinic, Angouleme
Angouleme, , 16000
Status
Recruiting
Address
Private Practice, Antibes
Antibes, , 06600
Status
Recruiting
Address
Private Practice 2, Antony
Antony, , 92160
Status
Recruiting
Address
Private Practice, Antony
Antony, , 92160
Status
Recruiting
Address
Private Practice 2, Arcachon
Arcachon, , 33120
Status
Recruiting
Address
Private Practice, Arcachon
Arcachon, , 33120
Status
Recruiting
Address
Private Practice, Argenteuil
Argenteuil, , 95100
Status
Recruiting
Address
Private Practice, Aubière
Aubière, , 63170
Status
Recruiting
Address
Private Practice, Auch
Auch, , 32000
Status
Recruiting
Address
Private Practice, Aussonne
Aussonne, , 31840
Status
Recruiting
Address
Auxerre Hospital
Auxerre, , 89000
Status
Recruiting
Address
Henri Duffaut Hospital
Avignon Cedex 9, , 84902
Status
Withdrawn
Address
Private Practice, Bar-Le-Duc
Bar-Le-Duc, , 55000
Status
Recruiting
Address
Private Practice, Bayonne
Bayonne, , 64100
Status
Recruiting
Address
Private Practice, Beaune
Beaune, , 21200
Status
Recruiting
Address
Private Practice, Besançon
Besançon, , 25000
Status
Recruiting
Address
Reims-Bezannes Polyclinic 2
Bezannes, , 51430
Status
Recruiting
Address
Reims-Bezannes Polyclinic 3
Bezannes, , 51430
Status
Recruiting
Address
Reims-Bezannes Polyclinic
Bezannes, , 51430
Status
Recruiting
Address
Private Practice, Biarritz
Biarritz, , 64200
Status
Recruiting
Address
Private Practice, Bordeaux
Bordeaux, , 33000
Status
Recruiting
Address
Private Practice 2, Bordeaux
Bordeaux, , 33300
Status
Recruiting
Address
Doctor Duchenne Hospital 3
Boulogne-sur-Mer, , 62200
Status
Recruiting
Address
Docteur Duchenne Hospital 2
Boulogne-sur-Mer, , 62321
Status
Recruiting
Address
Docteur Duchenne Hospital
Boulogne-sur-Mer, , 62321
Status
Recruiting
Address
Private Practice, Bègles
Bègles, , 33130
Status
Recruiting
Address
Private Practice 2, Caen
Caen, , 14000
Status
Recruiting
Address
Private Practice 3, Caen
Caen, , 14000
Status
Recruiting
Address
Private Practice, Caen
Caen, , 14000
Status
Recruiting
Address
Private Practice 2, Chalons-en-Champagne
Chalons-en -Champagne, , 51000
Status
Recruiting
Address
Private Practice, Chalons-en-Champagne
Chalons-en-Champagne, , 51000
Status
Recruiting
Address
Chalons-en-Champagne Hospital
Chalons-en-Champagne, , 51005
Status
Recruiting
Address
Private Practice, Chamalières
Chamalières, , 63400
Status
Recruiting
Address
Trousseau Hospital
Chambray-Les-Tours Cedex, , 37171
Status
Recruiting
Address
Métropole Savoie Hospital
Chambéry, , 73000
Status
Withdrawn
Address
Private Practice, Charleville Mezières
Charleville Mezières, , 08000
Status
Recruiting
Address
Private Practice 2, Chartres
Chartres, , 28000
Status
Recruiting
Address
Private Practice, Chartres
Chartres, , 28000
Status
Recruiting
Address
New Sud Francilien Hospital
Corbeil Essonnes, , 91100
Status
Recruiting
Address
Private Practice 2, Dijon
Dijon, , 21000
Status
Recruiting
Address
Private Practice 3, Dijon
Dijon, , 21000
Status
Recruiting
Address
Private Practice, Dijon
Dijon, , 21000
Status
Recruiting
Address
Private Practice, Dole
Dole, , 39100
Status
Recruiting
Address
Victor Jousselin Hospital
Dreux, , 28102
Status
Recruiting
Address
Emile Durkheim Hospital - Saint Jean Health Center
Epinal Cedex, , 88021
Status
Recruiting
Address
Private Practice, Essey-les-Nancy
Essey-les-Nancy, , 54270
Status
Recruiting
Address
Private Practice, Gardanne
Gardanne, , 13120
Status
Recruiting
Address
Golfe de St-Tropez Clinic
Gassin, , 83580
Status
Recruiting
Address
Private Practice 2, Joue les Tours
Joue les Tours, , 37300
Status
Recruiting
Address
Private Practice, Joue les Tours
Joue les Tours, , 37300
Status
Recruiting
Address
Private Practice 3, Joue les Tours
Joué-lés-Tours, , 37300
Status
Recruiting
Address
Private Practice, L'Union
L'Union, , 31240
Status
Recruiting
Address
Private Practice 2, La Teste-de-Buch
La Teste-de-Buch, , 33260
Status
Recruiting
Address
Private Practice, La Teste-de-Buch
La Teste-de-Buch, , 33260
Status
Recruiting
Address
Private Practice, La Valette du Var
La Valette du Var, , 83160
Status
Recruiting
Address
Private Practice, La Varenne Saint Hilaire
La Varenne Saint Hilaire, , 94210
Status
Recruiting
Address
Private Practice 2, Laval
Laval, , 53000
Status
Recruiting
Address
Private Practice, Laval
Laval, , 53000
Status
Recruiting
Address
Private Practice, Le Mans
Le Mans, , 72000
Status
Recruiting
Address
Le Mans Hospital 2
Le Mans, , 72037
Status
Recruiting
Address
Le Mans Hospital
Le Mans, , 72037
Status
Recruiting
Address
Private Practice, Le-Bourget-du-Lac
Le-Bourget-du-Lac, , 73370
Status
Recruiting
Address
Private Practice, Lille
Lille, , 59000
Status
Recruiting
Address
Private Practice 2, Luce
Luce, , 28110
Status
Recruiting
Address
Private Practice, Luce
Luce, , 28110
Status
Recruiting
Address
Private Practice, Lyon
Lyon, , 69002
Status
Recruiting
Address
Edouard Herriot Hospital
Lyon, , 69003
Status
Recruiting
Address
Private Practice 2, Lyon
Lyon, , 69006
Status
Recruiting
Address
Private Practice 3, Lyon
Lyon, , 69008
Status
Recruiting
Address
Private Practice 4, Lyon
Lyon, , 69008
Status
Recruiting
Address
Private Practice, Martigues
Martigues, , 13500
Status
Recruiting
Address
Annecy Genevois Hospital, Metz Tessy
Metz Tessy, , 74370
Status
Recruiting
Address
Private Practice, Meudon-la-Forêt
Meudon-la-Forêt, , 92360
Status
Recruiting
Address
Private Practice, Montbard
Montbard, , 21500
Status
Recruiting
Address
Private Practice, Muret
Muret, , 31600
Status
Recruiting
Address
Hotel Dieu Hospital, Dermatologic Clinic
Nantes, , 44093
Status
Withdrawn
Address
Private Practice, Nantes
Nantes, , 44100
Status
Recruiting
Address
Private Practice, Narbonne
Narbonne, , 11100
Status
Recruiting
Address
Private Practice, Nevers
Nevers, , 58000
Status
Recruiting
Address
Private Practice 2, Nice
Nice, , 06000
Status
Recruiting
Address
Private Practice 3, Nice
Nice, , 06000
Status
Withdrawn
Address
Private Practice, Nice
Nice, , 06000
Status
Recruiting
Address
Private Practice, Nogent-Le-Rotrou
Nogent-Le-Rotrou, , 28400
Status
Recruiting
Address
Private Practice, Orléans
Orléans, , 45000
Status
Recruiting
Address
Private Practice, Paris
Paris, , 75005
Status
Recruiting
Address
Private Practice 2, Paris
Paris, , 75006
Status
Recruiting
Address
Private Practice 3, Paris
Paris, , 75008
Status
Recruiting
Address
Private Practice 4, Paris
Paris, , 75009
Status
Recruiting
Address
Private Practice 5, Paris
Paris, , 75010
Status
Recruiting
Address
Private Practice, Pontarlier
Pontarlier, , 25300
Status
Recruiting
Address
Private Practice, Pontoise
Pontoise, , 95300
Status
Recruiting
Address
Private Practice, Quimper
Quimper, , 29000
Status
Recruiting
Address
CHI de Cornouaille - Laennec
Quimper, , 29107
Status
Recruiting
Address
Mathilde II Clinic
Rouen, , 76100
Status
Recruiting
Address
Private Practice, Saint-Etienne
Saint-Etienne, , 42000
Status
Withdrawn
Address
Private Practice, Sainte Maxime
Sainte Maxime, , 83120
Status
Recruiting
Address
Amiens Hospital
Salouel, , 80480
Status
Withdrawn
Address
Private Practice, Sanary sur Mer
Sanary sur Mer, , 83110
Status
Recruiting
Address
Saint-Etienne Hospital
St Priest en Jarez, , 42277
Status
Withdrawn
Address
Private Practice, Strasbourg
Strasbourg, , 67000
Status
Recruiting
Address
Private Practice, Torcy
Torcy, , 77200
Status
Recruiting
Address
BCRM Toulon - HIA Saint-Anne
Toulon Cedex 9, , 83800
Status
Recruiting
Address
Private Practice 2, Toulon
Toulon, , 83000
Status
Recruiting
Address
Private Practice, Toulon
Toulon, , 83000
Status
Recruiting
Address
Private Practice, Toulouse
Toulouse, , 31000
Status
Recruiting
Address
Private Practice 2, Toulouse
Toulouse, , 31300
Status
Recruiting
Address
Private Practice 3, Toulouse
Toulouse, , 31300
Status
Recruiting
Address
St Jean Languedoc Clinic 2
Toulouse, , 31400
Status
Withdrawn
Address
St Jean Languedoc Clinic, Toulouse
Toulouse, , 31400
Status
Recruiting
Address
Nord Franche-Comté Hospital
Trevenans, , 90400
Status
Recruiting
Address
Valence Hospital 2
Valence, , 26953
Status
Recruiting
Address
Valence Hospital 3
Valence, , 26953
Status
Recruiting
Address
Valence Hospital 4
Valence, , 26953
Status
Recruiting
Address
Valence Hospital
Valence, , 26953
Status
Withdrawn
Address
CHU Nancy Brabois, Vandoeuvre-les-Nancy
Vandoeuvre-les-Nancy, , 54500
Status
Withdrawn
Address
Private Practice, Vannes
Vannes, , 56000
Status
Recruiting
Address
Private Practice, Vence
Vence, , 06140
Status
Recruiting
Address
Jacques Lacarin Hospital
Vichy, , 03201