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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
French Health Products Safety Agency
Société de Dermatologie Française
Janssen, LP
Pfizer
Abbott
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01617018
First received: June 8, 2012
Last updated: February 11, 2014
Last verified: June 2012
  Purpose

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
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Multicentric Prospective Observational Cohort of Patients Receiving Systemic Treatment for Psoriasis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    Occurrence of skin cancer (spinocellular carcinomas [including carcinoma in situ (Bowen) and keratoacanthomas], basocellular carcinomas and melanomas).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: July 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Exposed group
Biotherapy
Non-exposed group
Major conventional systemic therapy (methotrexate or cyclosporine)

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 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617018

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
Abbott
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Olivier Chosidow, Md, Phd Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01617018     History of Changes
Other Study ID Numbers: AOM09195, N° IRB00006477
Study First Received: June 8, 2012
Last Updated: February 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Psoriasis; Biological therapy; Methotrexate; Cyclosporine

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014