NCT04841187Completed
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
French Registry of Patients Initiating Systemic Treatment for Cutaneous Psoriasis
Source: ClinicalTrials.gov · Last updated 18 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2000 (actual)
- First submitted
- 8 Mar 2021
- Start date
- 6 Sept 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Psoriasis
- NCT number
- NCT04841187
What you commit to
- Study type: Observational
- Participants enrolled: 2000
- From 6 Sept 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient for whom cutaneous psoriasis is not the main reason for systemic treatment (psoriatic arthritis, or concomitant Crohn's disease, etc.);
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.