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Swiss Dermatology Network of Targeted Therapies (SDNTT)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01706692
Acronym
SDNTT
Enrollment
1121
Registered
2012-10-15
Start date
2011-02-28
Completion date
2032-03-15
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Methotrexate, Acitretin, Cyclosporine A, Systemic PUVA, Infliximab, Adalimumab, Etanercept, Ustekinumab, Fumaric acids, Psoriasis, Psoriatic arthritis, Skin disease

Brief 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.

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

BIOLOGICALAdalimumab

all dosages, frequencies and durations prescribed

BIOLOGICALEtanercept

all dosages, frequencies and durations prescribed

BIOLOGICALInfliximab

all dosages, frequencies and durations prescribed

BIOLOGICALUstekinumab

all dosages, frequencies and durations prescribed

DRUGCyclosporine A

all dosages, frequencies and durations prescribed

DRUGFumaric acids

all dosages, frequencies and durations prescribed

DRUGMethotrexate

all dosages, frequencies and durations prescribed

DRUGOther anti-psoriatic systemic treatments

all dosages, frequencies and durations prescribed

Sponsors

Swiss Dermatology Network for Targeted Therapies
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Psoriasis Area Severity Index (PASI)every 6 months for 10 yearsTo evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Secondary

MeasureTime frameDescription
Dermatology Life Quality Index (DLQI)every 6 months for 10 yearsTo evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Other

MeasureTime frameDescription
Adverse and serious adverse events10 yearsRisk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026