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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,121
all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
Aarau Cantonal Hospital
Aarau, Switzerland
RECRUITINGBasel University Hospital
Basel, Switzerland
RECRUITINGInselspital - Bern University Hospital
Bern, Switzerland
Psoriasis Area Severity Index (PASI)
To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Time frame: every 6 months for 10 years
Dermatology Life Quality Index (DLQI)
To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Time frame: every 6 months for 10 years
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all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
all dosages, frequencies and durations prescribed
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
RECRUITINGSt. Gallen Cantonal Hospital
Sankt Gallen, Switzerland
RECRUITINGZurich University Hospital
Zurich, Switzerland
RECRUITING