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

NCT04841187 | Completed

• 2 other identifiers: APHP2011532020-A03437-32
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Psoriasis; Adult; Systemic treatment; Biological therapy; Biosimilar therapy; small-molecule inhibitor of phosphodiesterase 4 (PDE4); Methotrexate; Ciclosporin

Outcome Measures

Primary Outcomes (1)

• Occurrence of skin cancer

  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 Outcomes (20)

• Physicians global assessment of disease (PGA) score

  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

  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

  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

  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

  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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Société de Dermatologie Française: collaborator

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94010, France

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olivier CHOSIDOW, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: April 12, 2021
• Study Start: September 6, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)