ITMO public health
Last update : 07/01/2015 | Version : 1 | ID : 8863
| General | |
| Identification | |
| Detailed name | Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis |
| Sign or acronym | PSOBIOTEQ |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 911408 |
| General Aspects | |
| Medical area |
Cancer research Dermatology, venereology |
| Health determinants |
Medicine |
| Keywords | systemic conventional treatment, methotrexate, cyclosporine, health safety, real life, skin cancer, carcinoma, usage, biotherapy, infliximab, adalimumab, etanercept, ustekinumab, pharmacoepidemiology, exposure, melanoma |
| Scientific investigator(s) (Contact) | |
| Name of the director | Chosidow |
| Surname | Olivier |
| Address | 51 Avenue du Maréchal de Lattre de Tassigny 94010 Créteil |
| Phone | +33 (0)1 49 81 25 01 |
| olivier.chosidow@hmn.aphp.fr | |
| Unit | Service de DermatologieHôpital Henri Mondor |
| Organization | AP-HP |
| Name of the director | Tubach |
| Surname | Florence |
| Address | 46 rue Henri Huchard Secteur Claude Bernard 75877 Paris Cedex 18 |
| Phone | +33 (0)1 40 25 79 41/31 |
| florence.tubach@bch.aphp.fr | |
| Unit | Département d'Epidémiologie et Recherche CliniqueURC- Paris Nord INSERM CIC-EC 1425Hôpital Bichat |
| Organization | AP-HP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | 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. |
| Funding | |
| Funding status |
Mixed |
| Details | 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. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Société Française de Dermatologie |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | ABBVIE France |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | JANSSEN-CILAG |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | PFIZER |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | MSD FRANCE |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | - 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. |
| Database objective | |
| Main objective |
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. |
| Inclusion criteria |
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. |
| Population type | |
| 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 covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 07/2012 |
| Date of last collection (YYYY or MM/YYYY) | 07/2020 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2,636 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | -- |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Details of collected declarative data | SQ completed by patients at each study visit and telephone contact between follow-up visits. |
| Paraclinical data (detail) | -- |
| Biological data (detail) | -- |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | 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. |
| Classifications used | MeDRA |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 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. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
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. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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