Clinical trial NCT01706692: Swiss Dermatology Network of Targeted Therapies (SDNTT)
Official title: Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Keywords: Methotrexate
Acitretin
Cyclosporine A
Systemic PUVA
Infliximab
Adalimumab
Etanercept
Ustekinumab
Fumaric acids
Psoriasis
Psoriatic arthritis
Skin disease
Lead sponsor: Swiss Dermatology Network for Targeted Therapies
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 1121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not meeting the exclusion criteria will be eligible to participate in this registry.

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.

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)

Primary outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: every 6 months for 10 years
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: every 6 months for 10 years
Other outcomes:
measure: Adverse and serious adverse events
timeFrame: 10 years
Locations:
city: Aarau
country: Switzerland
facility: Aarau Cantonal Hospital
city: Basel
country: Switzerland
facility: Basel University Hospital
city: Bern
country: Switzerland
facility: Inselspital - Bern University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: St. Gallen
country: Switzerland
facility: St. Gallen Cantonal Hospital
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
affiliation: Swiss Society of Dermatology and Venereology (SSDV)
name: Alexander Navarini, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Society of Dermatology and Venereology (SSDV)
name: Julia-Tatjana Maul, PD Dr med
role: PRINCIPAL_INVESTIGATOR
References: