Assessing the Long Term Effectiveness and Safety of Biotherapies in the Treatment of Cutaneous Psoriasis (PSOBIOTEQ)

• ClinicalTrials.gov Identifier: NCT01617018
• Recruitment Status: Recruiting
• First Posted: June 12, 2012
• Last Update Posted: November 18, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: French Health Products Safety Agency; Société de Dermatologie Française; Janssen, LP; Pfizer; AbbVie; Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.

The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.

Condition or disease
Psoriasis

Detailed Description:

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 at least 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 patients will be included with the following distribution:.

• Non-exposed group: 1200 patients
• Exposed group: 1436 patients (naive or not) with at least 1200 patients naive for biotherapy.

Study Design

• Study Type: Observational
• Estimated Enrollment: 2636 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study
• Actual Study Start Date: July 2012
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Groups and Cohorts

Group/Cohort
Exposed group; Biotherapy
Non-exposed group; Major conventional systemic therapy (methotrexate or cyclosporine)

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Event-free survival; incidence of serious adverse events;effectiveness;therapeutic strategy,long-term safety(serious and non-serious adverse events,quality of life, rebounds after treatment discontinuation;maintenance of a therapeutic response over time [ 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) ]
   Composite measure

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patient consulting or being hospitalized for cutaneous psoriasis (clinical diagnosis), justifying the prescription of a major systemic therapy (methotrexate or cyclosporine, or biotherapy) and for whom cutaneous psoriasis is the main reason for systemic treatment

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.
• Patient for whom the treatment given at baseline cannot be identified (Patient participating to a double-blind trialinvolving biotherapies for example).

Contacts and Locations

Contacts

Contact: Olivier Chosidow, Md, Phd; 01 49 81 25 01; olivier.chosidow@hmn.aphp.fr

Contact: Hervé Bachelez, Md, Phd; 01 42 49 98 17; herve.bachelez@sls.aphp.fr

Locations

France

Henri Mondor Hospital; Recruiting

Creteil, ILE DE France, France

Principal Investigator: Olivier Chosidow, Pr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

French Health Products Safety Agency

Société de Dermatologie Française

Janssen, LP

Pfizer

AbbVie

Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Olivier Chosidow, Md, Phd; Assistance Publique - Hôpitaux de Paris

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01617018 History of Changes
• Other Study ID Numbers: AOM09195; N° IRB00006477 ( Other Identifier: EudraCTNumber )
• First Posted: June 12, 2012
• Last Update Posted: November 18, 2019
• Last Verified: November 2019

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Psoriasis; Biological therapy; Methotrexate; Cyclosporine

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Cyclosporine; Methotrexate; Cyclosporins; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Physiological Effects of Drugs; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Dermatologic Agents; Enzyme Inhibitors; Folic Acid Antagonists; Immunosuppressive Agents; Immunologic Factors; Antirheumatic Agents; Nucleic Acid Synthesis Inhibitors; Antifungal Agents; Anti-Infective Agents; Calcineurin Inhibitors