Swiss Dermatology Network of Targeted Therapies (SDNTT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adalimumab, Etanercept, Infliximab, Ustekinumab.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
Overview
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.
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.
Interventions
- Biological Adalimumab
all dosages, frequencies and durations prescribed - Biological Etanercept
all dosages, frequencies and durations prescribed - Biological Infliximab
all dosages, frequencies and durations prescribed - Biological Ustekinumab
all dosages, frequencies and durations prescribed - Drug Cyclosporine A
all dosages, frequencies and durations prescribed - Drug Fumaric acids
all dosages, frequencies and durations prescribed - Drug Methotrexate
all dosages, frequencies and durations prescribed - Drug Other anti-psoriatic systemic treatments
all dosages, frequencies and durations prescribed
Primary outcome measures
- Psoriasis Area Severity Index (PASI) [Time frame: every 6 months for 10 years]
Secondary outcome measures (1)
- Dermatology Life Quality Index (DLQI) [Time frame: every 6 months for 10 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 6 centers
- Aarau Cantonal Hospital — Aarau
- Basel University Hospital — Basel
- Inselspital - Bern University Hospital — Bern
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne
- St. Gallen Cantonal Hospital — Sankt Gallen
- Zurich University Hospital — Zurich
Identifiers
NCT: NCT01706692 · IMM 10-0138; P21007224R · CNTO1275PSO4028; AG110401-IIR