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

NCT01617018 | Completed

• 2 other identifiers: AOM09195N° IRB00006477
• Study Type: observational
• Target: 4,613
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Psoriasis; Biological therapy; Methotrexate; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Occurrence of skin cancer

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

  Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)

Secondary Outcomes (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

  Each patient will be followed for at least 5 years(8 years maximum), data being collected at each visit (approximately every 6 month)

Study Arms (2)

Exposed group

Biotherapy

Non-exposed group

Major conventional systemic therapy (methotrexate or cyclosporine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• French Health Products Safety Agency: collaborator
• Société de Dermatologie Française: collaborator
• Janssen, LP: collaborator
• Pfizer: collaborator
• AbbVie: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Henri Mondor Hospital

Créteil, Île-de-France Region, France

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Olivier Chosidow, Md, Phd

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: July 1, 2012
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

FR (1)