ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/07/2015 | Version : 1 | ID : 8863
| Général | |
| Identification | |
| Nom détaillé | Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis |
| Sigle ou acronyme | PSOBIOTEQ |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL: 911408 |
| Thématiques générales | |
| Domaine médical |
Cancer research Dermatology, venereology |
| Déterminants de santé |
Medicine |
| Mots-clés | systemic conventional treatment, methotrexate, cyclosporine, health safety, real life, skin cancer, carcinoma, usage, biotherapy, infliximab, adalimumab, etanercept, ustekinumab, pharmacoepidemiology, exposure, melanoma |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Chosidow |
| Prénom | Olivier |
| Adresse | 51 Avenue du Maréchal de Lattre de Tassigny 94010 Créteil |
| Téléphone | +33 (0)1 49 81 25 01 |
| olivier.chosidow@hmn.aphp.fr | |
| Laboratoire | Service de DermatologieHôpital Henri Mondor |
| Organisme | AP-HP |
| Nom du responsable | Tubach |
| Prénom | Florence |
| Adresse | 46 rue Henri Huchard Secteur Claude Bernard 75877 Paris Cedex 18 |
| Téléphone | +33 (0)1 40 25 79 41/31 |
| florence.tubach@bch.aphp.fr | |
| Laboratoire | Département d'Epidémiologie et Recherche CliniqueURC- Paris Nord INSERM CIC-EC 1425Hôpital Bichat |
| Organisme | AP-HP |
| Collaborations | |
| Participation à des projets, des réseaux, des consortiums |
Yes |
| Précisions | The PSOBIOTEQ meets the objective of the European PSONET project to develop standardised procedures for the sharing and analysis of national data registers for the long-term monitoring of the efficacy and safety of systemic psoriasis treatment. |
| Financements | |
| Financements |
Mixed |
| Précisions | Assistance Publique - Hôpitaux de Paris (Paris Public Hospital System), Ministry of Health (PHRC 2009). Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) [French National Agency for Medicine and Health Product Safety]. Janssen LP, Pfizer, Abbott, Merck Sharp and Dohme Corp laboratories. |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | AP-HP |
| Statut de l’organisation |
Secteur Public |
| Organisation(s) responsable(s) ou promoteur | Société Française de Dermatologie |
| Statut de l’organisation |
Secteur Public |
| Organisation(s) responsable(s) ou promoteur | ABBVIE France |
| Statut de l’organisation |
Secteur Privé |
| Organisation(s) responsable(s) ou promoteur | JANSSEN-CILAG |
| Statut de l’organisation |
Secteur Privé |
| Organisation(s) responsable(s) ou promoteur | PFIZER |
| Statut de l’organisation |
Secteur Privé |
| Organisation(s) responsable(s) ou promoteur | MSD FRANCE |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Cohort study |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | - Unexposed group: 1,200 patients - exposed group: - 1,200 biotherapy-naive patients - 1,436 non-biotherapy-naive patients with at least 323 patients treated with each biotherapy. |
| Objectif de la base de données | |
| Objectif principal |
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or conventional treatment) for moderate to severe cutaneous psoriasis.
PSOBIOTEQ is the result of merging two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists focusing on safety issues, and Pso-TEQ, developed by industrial teams at the request of the French Transparency Commission (Haute Autorité de Santé) that focuses on usage issues. The exposure of interest is the biological therapy exposure: Infliximab, Adalimumab, Etanercept and Ustekinumab. The general objective of PSOBIO is to assess the safety and efficacy of biotherapy in the treatment of cutaneous psoriasis "in real life" compared with conventional systemic therapy. However, Pso-TEQ has a descriptive objective concerning the usage methods of biological therapies "in real life" and the long-term benefits. |
| Critères d'inclusion |
Inclusion criteria:
- Patients aged 18 or over; - Attending or hospitalised in services participating in the study; - Has been informed of the research objectives and outcome and has signed an informed consent form to participate; - Cutaneous psoriasis (clinical diagnosis); - Justifying the prescription of major systemic therapy (Methotrexate or Cyclosporine or biotherapy) and belongs to one of the following 3 groups: - Patients beginning biotherapy (Infliximab, Adalimumab, Etanercept, Ustekinumab and other biotherapy entering the market) AND who have not been previously exposed; - Patients beginning biotherapy AND who have been already exposed. - Patients exposed to major conventional systemic treatment (excluding biotherapy) for at least 3 months (Methotrexate or Cyclosporine) AND for which no biotherapy treatment is planned within the next 6 months AND are naive to all biotherapy. Exclusion criteria: - Patients for whom cutaneous psoriasis is not the main reason for systemic treatment (biotherapy or conventional treatment); treatment justified by psoriatic arthritis, concomitant Crohn's disease, etc. - Patients unable to comply with the cohort monitoring (unreachable by phone, unable to complete the self -administered questionnaire) or whose follow-up is expected to be difficult. |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Metropolitan France |
| Collecte | |
| Dates | |
| Année du premier recueil | 07/2012 |
| Année du dernier recueil | 07/2020 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[1000-10 000[ individuals |
| Détail du nombre d'individus | 2,636 |
| Données | |
| Activité de la base |
Current data collection |
| Type de données recueillies |
Clinical data Declarative data Paraclinical data Biological data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Détail des données cliniques recueillies | -- |
| Données déclaratives, précisions |
Paper self-questionnaire Phone interview |
| Détail des données déclaratives recueillies | SQ completed by patients at each study visit and telephone contact between follow-up visits. |
| Données paracliniques, précisions | -- |
| Données biologiques, précisions | -- |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Consommation de soins, précisions |
Medicines consumption |
| Modalités | |
| Mode de recueil des données | Collection of clinical and paraclinical data within the cohort will be carried out using a CleanWEB Electronic Case Report Form. An adjudication committee shall validate the potential SAEs and significant medical effects presented to them. The events requiring adjudication will be listed by the Scientific Committee for the study. Events to be adjudicated will be sent to experts through anonymised data transfer by CRA under the coordination of the project head. Adjudication will be applied to treatment received (biotherapy or not), based on clinical history and to possible photographs and additional adapted tests. |
| Nomenclatures employées | MeDRA |
| Suivi des participants |
Yes |
| Détail du suivi | Follow-up every 6 months for a minimum of 5 years and a maximum of 8 years. A self-administered questionnaire was completed by the patient at each visit and follow-up by telephone is in place for the prompt notification of an event or change in treatment and to ensure continuous monitoring. |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) |
Data belongs to AP-HP and cannot be used or sent to a third party without prior consent.
Access to data is by request to the Psobioteq project scientific committee; Access shall also be subject to a partnership contract signed between AP-HP and the legal representative of the requesting team specifying the terms and conditions of data provision. Every laboratory participating in the Psobioteq study will have access to data involving their product. Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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