Swiss Dermatology Network of Targeted Therapies (SDNTT)

Psoriasis Clinical Trial

— SDNTT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01706692
• Other study ID #: IMM 10-0138; P21007224R
• Secondary ID: CNTO1275PSO4028
• Status: Recruiting
• Start date: July 2011
• Est. completion date: June 2033

Study information

• Verified date: May 2022
• Source: Swiss Dermatology Network for Targeted Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 2033
• Est. primary completion date: June 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Adalimumab
all dosages, frequencies and durations prescribed
• Etanercept
all dosages, frequencies and durations prescribed
• Infliximab
all dosages, frequencies and durations prescribed
• Ustekinumab
all dosages, frequencies and durations prescribed

Drug:
• Cyclosporine A
all dosages, frequencies and durations prescribed
• Fumaric acids
all dosages, frequencies and durations prescribed
• Methotrexate
all dosages, frequencies and durations prescribed
• Other anti-psoriatic systemic treatments
all dosages, frequencies and durations prescribed

Locations

Country	Name	City	State
Switzerland	Aarau Cantonal Hospital	Aarau
Switzerland	Basel University Hospital	Basel
Switzerland	Inselspital - Bern University Hospital	Bern
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	St. Gallen Cantonal Hospital	St. Gallen
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Dermatology Network for Targeted Therapies

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse and serious adverse events	Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	10 years
Primary	Psoriasis Area Severity Index (PASI)	To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 6 months for 10 years
Secondary	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	every 6 months for 10 years

External Links

•   German registry PsoBest