PsoBest - The German Psoriasis Registry

Study Purpose

Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). 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. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.

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 [Patient Registry]
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 years.
  • - being administered a specific systemic drug for the first time.
  • - informed consent to participate.
  • - sufficient language skills (German)

    Exclusion criteria:

    - lack of informed consent.
- patients being participants of clinical trials at the day of admission to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analysed 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.

NCT01848028
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.

Universitätsklinikum Hamburg-Eppendorf
Principal Investigator

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

Matthias Augustin, Prof. Dr.
Principal Investigator Affiliation Universitätsklinikum Hamburg-Eppendorf
Agency Class

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

Other, Industry
Overall Status Recruiting
Countries Germany
Conditions

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

Psoriasis, Psoriatic-arthritis
Study Website: View Trial Website
Additional Details

Background: Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). 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. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. Objectives: Observation and analysis of the following outcomes of treatment with systemic antipsoriatics: 1. Effectiveness in clinical practice ("real world") 2. Benefits and needs on the patients' side. 3. Effectiveness in a long-term course over years. 4. Optimal maintenance dosages. 5. Safety and side-effects profile under routine conditions. 6. Use in case of and effect on co-morbidity. 7. Reliable predictors of response. 8. Benefit and effectiveness of possible combination therapies or alternating use of biologics and systemic therapies. Methods: The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.The registry started for seven treatment arms: Fumaric acid, methotrexate, ciclosporin A, efalizumab, etanercept, infliximab and adalimumab. While efalizumab was withdrawn from the market, ustekinumab was included after authorization. Patients are included at first initiation of a given treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment consecutively enrol patients. Follow-ups will be every 3 to 6 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. PsoBest is member of the ENCePP network of psoriasis-registries (www.psonet.eu).

Arms & Interventions

Arms

: Fumaric acid esters

Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, all dosages, frequencies and durations prescribed

: Methotrexate

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

: Cyclosporine A

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

: Efalizumab (withdrawn)

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

: Etanercept

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

: Infliximab

Intervention: Biological and Biosimilars/-identicals: Infliximab, all dosages, frequencies and durations prescribed

: Adalimumab

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

: Ustekinumab

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

: Golimumab

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

: Secukinumab

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

: Apremilast

Intervention: Small molecule: Apremilast, all dosages, frequencies and durations prescribed

: Certolizumab

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

: Retinoids

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

: Leflunomids

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

: systemic PUVA

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

: Guselkumab

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

: Brodalumab

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

: Tildrakizumab

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

: Risankizumab

Intervention: Biological: systemic Risankizumab, all dosages, frequencies and durations prescribed

: Bimekizumab

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

: Tofacitinib

Intervention: JAK-Inhibitor: Tofacitinib, all dosages, frequencies and durations prescribed

: Upadacitinib

Intervention: JAK-Inhibitor: Upadacitinib, all dosages, frequencies and durations prescribed

: Baricitinib

Intervention: JAK-Inhibitor: Baricitinib, all dosages, frequencies and durations prescribed

: Deucravacitinib

Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed

: Ixekizumab

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

Interventions

Contact a Trial Team

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International Sites

Hamburg, Germany

Status

Recruiting

Address

Nationwide group of dermatological centers, hospitals and medical offices

Hamburg, ,

Site Contact

Matthias Augustin, Prof. Dr.

m.augustin@uke.de

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