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

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ClinicalTrials.gov Identifier: NCT01617018
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : July 23, 2018
Sponsor:
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

Tracking Information
First Submitted Date June 8, 2012
First Posted Date June 12, 2012
Last Update Posted Date July 23, 2018
Study Start Date July 2012
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2012)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01617018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 11, 2015)
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
Original Secondary Outcome Measures
 (submitted: June 8, 2012)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessing the Long Term Effectiveness and Safety of Biotherapies in the Treatment of Cutaneous Psoriasis
Official Title Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Psoriasis
Intervention Not Provided
Study Groups/Cohorts
  • Exposed group
    Biotherapy
  • Non-exposed group
    Major conventional systemic therapy (methotrexate or cyclosporine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 11, 2015)
2636
Original Estimated Enrollment
 (submitted: June 8, 2012)
3000
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01617018
Other Study ID Numbers AOM09195
N° IRB00006477 ( Other Identifier: EudraCTNumber )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators
  • 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
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2018