Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis — PSOBIOTEQ  

Psoriasis Clinical Trial

Official title: French Registry of Patients Initiating Systemic Treatment for Cutaneous Psoriasis

Status Completed

Clinical Trial Summary

PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis. The general objective of PSOBIOTEQ registry is to describe the use, benefits and risks of conventional, biological, biosimilar and small-molecule inhibitor of phosphodiesterase 4 (PDE4) systemic treatments in a real-life setting.

The registry aims to meet many specific objectives and to fulfill ancillary studies. The PSOBIOTEQ registry concerns a largely similar population and has same objectives than the PSOBIOTEQ Cohort (NCT01617018). Indeed, data from the PSOBIOTEQ cohort will constitute the historical part of the registry and the cohort patients will pursue their follow-up in the registry framework, in order to enrich their follow up with new collected data.

Clinical Trial Description

PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis.

The exposure of interest is the exposure to any major systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis and marketed in France at the time of inclusion of the patient in the registry.

The nature of the systemic treatment as well as its administration modalities are defined by the investigator according to usual practice.

The dermatology departments participating to the PSOBIOTEQ cohort were solicited for participation to the PSOBIOTEQ registry.

The PSOBIOTEQ registry will start in 2020 with 28 dermatology departments. The PSOBIOTEQ cohort started in 2012 and was finalized in 2020. The PSOBIOTEQ registry continues from 2020 till 2025.

The inclusion will last 4 years with a follow-up of at least 1 year of the latest patient and until the end of the research for the other patients with a 6 month periodicity and at least one visit per year, for the data collection (complying with good clinical practice for these patients). Each included patient remains followed-up as long as he doesn't object.

All data required will be collected and registered in a single database (eCRF). The statistical analyses planned in the research protocol and those responding to requests for additional data from the Transparency Committee in the context of the provision of biomedicines, their biosimilars or other major systemic treatments obtaining Marketing Authorization in the treatment of cutaneous psoriasis, will be performed by the pharmaco-epidemiology center (CEPHEPI) under the responsibility of Pr Florence TUBACH of La Pitié Salpêtrière hospital.

The ancillary studies analyses responding to general objectives of the registry dealing with psoriasis and its course, the terms of use or the benefits and risks of its treatments (for example in case of identification of safety signals) or new research questions emerging during the conduct of the study (or after the study), whose realization is validated by the scientific committee of the registry may be carried out by CEPHEPI or the academic teams participating in the PSOBIOTEQ registry.

A calculation of the sample size is not justified for this study as it aims to describe all the patients initiating systemic treatment for cutaneous psoriasis in the participating centers. However, based on the rate of inclusion in the PSOBIOTEQ cohort, an inclusion rate of 500 patients per year can be estimated (therefore 2000 patients to be included in 4 years). ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT04841187
• Study type: Observational [Patient Registry]
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Start date: September 6, 2021
• Completion date: December 31, 2023