NCT01848028

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2008Dec 2032

Study Start

First participant enrolled

January 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
19.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

24.9 years

First QC Date

April 7, 2013

Last Update Submit

January 23, 2025

Conditions

PsoriasisPsoriatic-arthritis

Keywords

patient registryGermanypsoriasispsoriatic-arthritisbiologicsPsoneteffectivenesssafetybiosimilars

Outcome Measures

Primary Outcomes (1)

  • Psoriasis Area Severity Index (PASI)

    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

    every 6 month for 10 years

Secondary Outcomes (1)

  • Dermatology Life Quality Index (DLQI)

    every 3 month for 10 years

Other Outcomes (8)

  • Adverse and serious adverse events

    6 month

  • Patient Benefit Index (PBI)

    every 3 months for 10 years

  • EuroQol Questionnaire (EQ-5D)

    every 3 months for 10 years

  • +5 more other outcomes

Study Arms (25)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide group of dermatological centers, hospitals and medical offices

Hamburg, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Matthias Augustin, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2013

First Posted

May 7, 2013

Study Start

January 1, 2008

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

DE(1)