Recruiting

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

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What is being collected

Biological Data

+ biological Data

+ biological Data

Collected from today forward - Prospective
BiologicalDrug
Who is being recruted

Arthritis+10

+ Bone Diseases

+ Joint Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2011
See protocol details

Summary

Principal SponsorSwiss Dermatology Network for Targeted Therapies
Study ContactMarcus Streit, Dr. med.More contacts
Last updated: November 29, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01706692
Principal SponsorSwiss Dermatology Network for Targeted Therapies
Study ContactMarcus Streit, Dr. med.More contacts
Last updated: November 29, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1121 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesSpinal DiseasesSpondylitisSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathiesPsoriasisSkin DiseasesArthritis, Psoriatic

Criteria

5 inclusion criteria required to participate
Being administered a specific biologic/conventional systemic drug for the first time

Informed consent to participate

Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist

Sufficient language skills (German, French, Italian and English) for the informed consent to participate

Show More Criteria

2 exclusion criteria prevent from participating
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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

8 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Recruiting

Aarau Cantonal Hospital

Aarau, SwitzerlandOpen Aarau Cantonal Hospital in Google Maps
Recruiting

Basel University Hospital

Basel, Switzerland
Recruiting

Inselspital - Bern University Hospital

Bern, Switzerland
Recruiting

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland
Recruiting
6 Study Centers