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French Multicentric Prospective Observational Cohort of Patients Receiving Systemic Treatment for Psoriasis

18 Years
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Trial Information

French Multicentric Prospective Observational Cohort of Patients Receiving Systemic Treatment for Psoriasis

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 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 to 3 836 patients will be included with the following distribution:.

- Non-exposed group: 1200 patients

- Exposed group: 1200 patients naive for biotherapy ; 1436 patients (naive or not)

Inclusion Criteria

Inclusion criteria:

- Patients aged 18 years

- Having been informed of the objectives and conduct of the research and having signed
a written informed consent to participate

- Consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis)
justifying the prescription of a major systemic therapy and for whom cutaneous
psoriasis is the main reason for systemic treatment and belonging to one of the two
following groups:

- Patients exposed to a major conventional systemic therapy (methotrexate or
cyclosporine, excluding biotherapies) since at least 3 months and for which
there are no plans to institute treatment with biotherapy in the next 6 months :
non-exposed group.

- Patients exposed to a biological therapy (infliximab, adalimumab, etanercept,
ustekinumab and other biotherapy entering the market) : exposed group.

Exclusion criteria:

- Patients for whom cutaneous psoriasis is not the main reason for systemic treatment:
treatment justified by psoriatic arthritis, concomitant Crohn's disease ...;

- Patients unable to comply with the planned cohort monitoring or whose follow-up is
expected to be difficult.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Occurrence of skin cancer

Outcome Description:

Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).

Outcome 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)

Safety Issue:


Principal Investigator

Olivier Chosidow, Md, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

July 2012

Completion Date:

Related Keywords:

  • Psoriasis
  • Psoriasis; Biological therapy; Methotrexate; Cyclosporine
  • Psoriasis