FRESH-PEF8863-en
Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis
PSOBIOTEQ
| Name |
|---|
| France |
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.
['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Behavioral data']
Individuals
| Topic | Vocabulary | URI |
|---|---|---|
| Oncology | health theme | |
| Dermatology | health theme | |
| cim-11 | http://id.who.int/icd/entity/322865591 | |
| cim-11 | http://id.who.int/icd/entity/322865591 | |
| Healthcare system determinants: Use of care | health determinant | |
| Healthcare system determinants | health determinant |
{
"level_sex_clusion_I": [
"Male",
"Female"
],
"level_age_clusion_I": [
"Young Adult (19 to 24 years)",
"Adult (25 to 44 years)",
"Middle Aged (45 to 64 years)",
"Aged (65 to 79 years)",
"Aged, 80 and over (80 years and more)"
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "",
"clusion_E": ""
}
| Name |
|---|
| Florence Tubach |
| Olivier Chosidow |
| Name | Role |
|---|---|
| ABBVIE | sponsor |
| JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) | sponsor |
| MSD FRANCE | sponsor |
| PFIZER (FRANCE) | sponsor |
| ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) | sponsor |
| Name |
|---|
| ABBOTT FRANCE |
| JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) |
| MSD FRANCE |
| PFIZER (FRANCE) |
| AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM) |
| ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) |
| MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES |
| Agency name |
|---|
| CNIL |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['Other']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2012 | 2020 |
Longitudinal or cohort study
| Standard |
|---|
| ['MeDRA'] |
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.
Restricted access
Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document.
| Name | |
|---|---|
| Florence Tubach | florence.tubach@aphp.fr |
| Olivier Chosidow | olivier.chosidow@aphp.fr |
FRESH-PEF8863-en