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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Germany
Nationwide group of dermatological centers, hospitals and medical offices
RECRUITING
Hamburg
Time Frame
Start Date: 2008-01
Estimated Completion Date: 2032-12
Participants
Target number of participants: 3500
Treatments
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Efalizumab (withdrawn)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 and Biosimilars: 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
Deucravacitinib
Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed
Ixekizumab
Intervention: Biological: Ixekizumab, all dosages, frequencies and durations prescribed
No treatment
Intervention: no systemic treatment in observation episodes
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC, Merck Serono GmbH, Germany, Eli Lilly and Company, AbbVie, LEO Pharma, Celgene, Viatris Inc., PsoNet.eu (http://www.psonet.eu/), Novartis Pharmaceuticals, Deutsche Dermatologische Gesellschaft e.V. (https://derma.de), Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de), Pfizer Pharmaceuticals Ltd., Bristol-Myers Squibb, Amgen, Janssen-Cilag G.m.b.H, Almirall Hermal GmbH, medac GmbH, UCB Pharma, Biogen
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov