Swiss Dermatology Network of Targeted Therapies (SDNTT)

Last updated: November 27, 2024
Sponsor: Swiss Dermatology Network for Targeted Therapies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Rash

Scalp Disorders

Treatment

Ustekinumab

Infliximab

Fumaric acids

Clinical Study ID

NCT01706692
IMM 10-0138; P21007224R
CNTO1275PSO4028; AG110401-IIR
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.

The registry will also evaluate safety clinical outcomes and health related quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed bya dermatologist,

  • age ≥ 18,

  • Being administered a specific biologic/conventional systemic drug for the first time

  • Sufficient language skills (German, French, Italian and English) for the informedconsent to participate

  • Informed consent to participate

Exclusion

Exclusion Criteria:

  • Lack of informed consent

  • Patients being participants of clinical trials at the day of registration to theregistry (if a patient is included into a clinical trial during the registryfollow-ups, the patient data will be recorded, but analyzed separately)

Study Design

Total Participants: 1121
Treatment Group(s): 8
Primary Treatment: Ustekinumab
Phase:
Study Start date:
February 01, 2011
Estimated Completion Date:
March 15, 2032

Study Description

Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.

The study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 months, comprising patient and treatment characteristics, clinical parameters, patient-defined benefit, quality of life and adverse events. Standardized questionnaires will be addressed to the patient and to the dermatologist 12 times at the dermatologic centres. In interim intervals, patients are directly contacted another 9 times by mail.

Connect with a study center

  • Aarau Cantonal Hospital

    Aarau, CH-5001
    Switzerland

    Active - Recruiting

  • Basel University Hospital

    Basel, CH-4031
    Switzerland

    Active - Recruiting

  • Inselspital - Bern University Hospital

    Bern, CH-3001
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, CH-1011
    Switzerland

    Active - Recruiting

  • St. Gallen Cantonal Hospital

    St. Gallen, CH-9007
    Switzerland

    Active - Recruiting

  • Zurich University Hospital

    Zurich, CH-8091
    Switzerland

    Active - Recruiting

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