Assessing the Long Term Effectiveness and Safety of Biotherapies in the Treatment of Cutaneous Psoriasis (PSOBIOTEQ)
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|ClinicalTrials.gov Identifier: NCT01617018|
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : November 27, 2017
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.
The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.
|Condition or disease|
PSOBIOTEQ is a national multicentric prospective cohort, including patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis.
The exposure of interest is the exposure to a biological therapy: infliximab, adalimumab, etanercept, ustekinumab and other biotherapy entering the market.
The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice.
All dermatology departments located in the French metropolitan area and using biotherapies as treatment of cutaneous psoriasis will be solicited for participation to the cohort.
The inclusion will last at least 3 years with a follow-up of at least 5 years for each patient (8 years maximum), with a 6 month periodicity for the data collection (complying with good clinical practice for these patients). Follow-up duration may be extended in the case of the identification of safety signals in the early years.
Each study within the cohort has its specific endpoints according to its specific objectives but the whole data required will be collected at the same time for both studies then registered in a single database (eCRF). The statistical analyses will be performed by the clinical investigation and epidemiology center (INSERM CIE 801) of BICHAT hospital's department of epidemiology and clinical research
2 636 patients will be included with the following distribution:.
- Non-exposed group: 1200 patients
- Exposed group: 1436 patients (naive or not) with at least 1200 patients naive for biotherapy.
|Study Type :||Observational|
|Estimated Enrollment :||2636 participants|
|Official Title:||Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Major conventional systemic therapy (methotrexate or cyclosporine)
- Occurrence of skin cancer [ Time Frame: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month) ]Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).
- Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time [ Time Frame: Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month) ]Composite measure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617018
|Contact: Olivier Chosidow, Md, Phd||01 49 81 25 email@example.com|
|Contact: Hervé Bachelez, Md, Phd||01 42 49 98 firstname.lastname@example.org|
|Henri Mondor Hospital||Recruiting|
|Creteil, ILE DE France, France|
|Principal Investigator: Olivier Chosidow, Pr|
|Principal Investigator:||Olivier Chosidow, Md, Phd||Assistance Publique - Hôpitaux de Paris|