Swiss Dermatology Network of Targeted Therapies (SDNTT)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01706692
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Swiss Dermatology Network for Targeted Therapies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexander Navarini, Prof Dr medJulia-Tatjana Maul, PD Dr med
Principal Investigator Affiliation Swiss Society of Dermatology and Venereology (SSDV)Swiss Society of Dermatology and Venereology (SSDV)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Adalimumab

Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed

: Etanercept

Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed

: Infliximab

Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed

: Ustekinumab

Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed

: Cyclosporine A

Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed

: Fumaric acids

Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed

: Methotrexate

Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed

: Other anti-psoriatic systemic treatments

e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aarau Cantonal Hospital, Aarau, Switzerland

Status

Recruiting

Address

Aarau Cantonal Hospital

Aarau, , CH-5001

Site Contact

Marcus Streit, Dr. med.

markus.streit@ksa.ch

062 838 68 38

Basel University Hospital, Basel, Switzerland

Status

Recruiting

Address

Basel University Hospital

Basel, , CH-4031

Site Contact

Alexander Navarini, Prof.

Alexander.Navarini@usb.ch

Inselspital - Bern University Hospital, Bern, Switzerland

Status

Recruiting

Address

Inselspital - Bern University Hospital

Bern, , CH-3001

Site Contact

Luca Borradori, Prof.

Luca.Borradori@insel.ch

031 632 2111

Lausanne, Switzerland

Status

Recruiting

Address

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , CH-1011

Site Contact

Michel Gilliet, Prof.

michel.gilliet@chuv.ch

St. Gallen Cantonal Hospital, St. Gallen, Switzerland

Status

Recruiting

Address

St. Gallen Cantonal Hospital

St. Gallen, , CH-9007

Site Contact

Antonio Cozzio, Prof.

Antonio.Cozzio@kssg.ch

Zurich University Hospital, Zurich, Switzerland

Status

Recruiting

Address

Zurich University Hospital

Zurich, , CH-8091

Site Contact

Tatjana Maul, PD Dr.

Julia-Tatjana.Maul@usz.ch

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