Swiss Dermatology Network of Targeted Therapies (SDNTT)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2033
  • participants needed
    750
  • sponsor
    Swiss Dermatology Network for Targeted Therapies
Updated on 26 January 2021
cyclosporine
methotrexate
adalimumab
ustekinumab
infliximab
etanercept
arthritis
puva
acitretin

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.

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.

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders
Treatment methotrexate, Etanercept, Infliximab, Adalimumab, ustekinumab, Cyclosporine A, Fumaric acids, Other anti-psoriatic systemic treatments
Clinical Study IdentifierNCT01706692
SponsorSwiss Dermatology Network for Targeted Therapies
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a 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 informed consent to participate
Informed consent to participate

Exclusion Criteria

Lack of informed consent
Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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