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

January 17, 2024 updated by: Assistance Publique - Hôpitaux de Paris

French Registry of Patients Initiating Systemic Treatment for Cutaneous Psoriasis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Créteil, France, 94010
        • Hopital Henri Mondor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The studied population corresponds to adult patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis in the centers participating to the PSOBIOTEQ Registry.

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.

Description

Inclusion Criteria:

  • Patient aged 18 or over
  • Had been informed about the objectives and progress of the research, and not opposed to the collection of his data
  • Consulting or hospitalized in one of the departments participating in the study :
  • For a cutaneous psoriasis (clinical diagnosis)

  • And at least one of the two criteria below must be met :

    • In whom a systemic treatment is initiated (excluding phototherapy or acitretin) that he has never received in the past * (a patient who has already received a biomedicine (princeps and / or biosimilar (s)) in the past cannot be included under the same biomedicine (princeps and / or biosimilar (s)). Patients initiating treatment with methotrexate or ciclosporin must be naïve of any biomedicine.
    • Patients included in the PSOBIOTEQ 1 cohort

Exclusion Criteria:

  • Patient for whom cutaneous psoriasis is not the main reason for systemic treatment (psoriatic arthritis, or concomitant Crohn's disease, etc.);
  • Patient unable to comply with the registry's follow-up procedures (not reachable by phone, unable to complete the self-questionnaire) or whose monitoring is deemed difficult;
  • Patient for whom the treatment administered at inclusion cannot be identified (patient included in a randomized double-blind biomedicine research protocol, for example).
  • Patient under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of skin cancer
Time Frame: Up to 5 years of follow up for each patient
Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).
Up to 5 years of follow up for each patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Physicians global assessment of disease (PGA) score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Psoriasis Area and Severity Index (PASI) Score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Body surface area
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Dermatology Life Quality Index (DLQI) Score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Global Self Assessed (GSA) Score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) index score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Patient Report of Extent of Psoriasis Involvement (PREPI) score
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients reporting acceptable symptom state : acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients reporting clinically important improvement in psoriasis activity during the last 48 hours compared to baseline
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Occurrence of Adverse Events and Serious Adverse Events
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Occurrence of Events of special interest such as infectious diseases, autoimmune diseases, lymphoma and blood disorders, multiple solid tumors, cardiovascular diseases, etc.
Time Frame: [Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
[Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Drug survival rate (proportion of patients still exposed to treatment
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Socio-demographic and clinical data: age, sex, socio-professional category, body mass index (BMI) and phototype (Fitzpatrick)
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Lifestyle data: family life, tobacco consumption, alcohol consumption and history of natural and artificial UV exposure
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with history and comorbidities
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with previous systemic treatments including phototherapy and acitretin
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with systemic treatments
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Number of patients with concomitant treatments
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Daily dose of systemic treatments
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Therapeutic strategy: duration of systemic treatments, dosages, change in systemic treatments, reasons for modifications of systemic treatments
Time Frame: Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.
Each patient will be followed for at least 1 year (The duration of follow-up is 5 years), data being collected at each visit (approximately every 6 month) with a minimum of one medical visit per year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Société de Dermatologie Française

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier CHOSIDOW, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP201153
  • 2020-A03437-32 (Registry Identifier: Number ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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