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NCT Number: NCT01706692

Swiss Dermatology Network of Targeted Therapies (SDNTT)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarau Cantonal Hospital, Aarau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adalimumab

Biological

all dosages, frequencies and durations prescribed

Other names: Humira

etanercept

Biological

all dosages, frequencies and durations prescribed

Other names: Enbrel

Infliximab

Biological

all dosages, frequencies and durations prescribed

Other names: Remicade

Ustekinumab

Biological

all dosages, frequencies and durations prescribed

Other names: Stelara

Cyclosporine A

Drug

all dosages, frequencies and durations prescribed

Fumaric acids

Drug

all dosages, frequencies and durations prescribed

methotrexate

Drug

all dosages, frequencies and durations prescribed

Other anti-psoriatic systemic treatments

Drug

all dosages, frequencies and durations prescribed

Primary outcomes

  1. Psoriasis Area Severity Index (PASI)

    Time frame: every 6 months for 10 years

    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Secondary outcomes

  1. Dermatology Life Quality Index (DLQI)

    Time frame: every 6 months for 10 years

    To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Other outcomes

  1. Adverse and serious adverse events

    Time frame: 10 years

    Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Sponsors and collaborators

Lead sponsor

Swiss Dermatology Network for Targeted Therapies

Other

Registry information

Official study title

Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics

Acronym: SDNTT

Important dates

Study start
2011
Primary completion
2032
Study completion
2032
First posted
Oct 15, 2012
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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