FRESH-PEF8863-en
Multicentric Cohort of Patients Receiving Systemic Treatment (Conventional or Biotherapy) for Moderate to Severe Cutaneous Psoriasis
PSOBIOTEQ
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Behavioral data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Dermatology | health theme |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{
"level_sex_clusion_I": [
{
"value": "Male",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
}
},
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Young Adult (19 to 24 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
}
},
{
"value": "Adult (25 to 44 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
}
},
{
"value": "Middle Aged (45 to 64 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
}
},
{
"value": "Aged (65 to 79 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
}
},
{
"value": "Aged, 80 and over (80 years and more)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
}
}
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "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. ",
"clusion_E": "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.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."
}
| Name |
|---|
| Olivier;CHOSIDOW |
| Florence;TUBACH |
| Name | Role |
|---|---|
| SOCIETE FRANÇAISE DE DERMATOLOGIE ET DE PATHOLOGIE SEXUELLEMENT TRANSMISSIBLE | sponsor |
| ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) | sponsor |
| MSD FRANCE | sponsor |
| PFIZER (FRANCE) | sponsor |
| JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) | sponsor |
| ABBVIE | sponsor |
| Name |
|---|
| ABBOTT FRANCE |
| AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM) |
| ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) |
| JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE) |
| MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES |
| MSD FRANCE |
| PFIZER (FRANCE) |
| Name |
|---|
| 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. |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2012-01-01 | 2020-01-01 |
| 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.
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
Psonet study variables (European study) will be sent to the European registry according to the terms outlined in a specific document.
| Name | |
|---|---|
| Olivier;CHOSIDOW | olivier.chosidow@aphp.fr |
| Florence;TUBACH | florence.tubach@aphp.fr |
FRESH-PEF8863-en
| Name | Affiliation |
|---|---|
| SARRA POCHON | ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) |