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Swiss Dermatology Network of Targeted Therapies (SDNTT) (SDNTT)

  Purpose

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 5 years, regardless of subsequent therapy.

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

Condition Intervention
Psoriasis Biological: Adalimumab Biological: Etanercept Biological: Infliximab Biological: Ustekinumab Drug: Cyclosporine A Drug: Fumaric acids Drug: Methotrexate Drug: Other anti-psoriatic systemic treatments

Study Type: Observational
Study Design:Observational Model: Cohort
Time Perspective: Prospective
Official Title:Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics

Resource links provided by NLM:

Further study details as provided by Swiss Dermatology Network for Targeted Therapies:

Primary Outcome Measures:

  • Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 months for 5 years ]
    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Secondary Outcome Measures:

  • Dermatology Life Quality Index (DLQI) [ Time Frame: every 6 months for 5 years ]
    To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Other Outcome Measures:

  • Adverse and serious adverse events [ Time Frame: 5 years ]
    Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Estimated Enrollment:500
Study Start Date:July 2011
Estimated Study Completion Date:June 2021
Estimated Primary Completion Date:June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adalimumab

Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed
Biological: Adalimumab

all dosages, frequencies and durations prescribed
Other Name: Humira
Etanercept

Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed
Biological: Etanercept

all dosages, frequencies and durations prescribed
Other Name: Enbrel
Infliximab

Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed
Biological: Infliximab

all dosages, frequencies and durations prescribed
Other Name: Remicade
Ustekinumab

Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed
Biological: Ustekinumab

all dosages, frequencies and durations prescribed
Other Name: Stelara
Cyclosporine A

Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed
Drug: Cyclosporine A

all dosages, frequencies and durations prescribed
Fumaric acids

Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed
Drug: Fumaric acids

all dosages, frequencies and durations prescribed
Methotrexate

Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed
Drug: Methotrexate

all dosages, frequencies and durations prescribed
Other anti-psoriatic systemic treatments

e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed
Drug: Other anti-psoriatic systemic treatments

all dosages, frequencies and durations prescribed

Detailed 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.

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