PsoBest - The German Psoriasis Registry

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01848028
• Other study ID #: IVDP-085-07
• Status: Recruiting
• Start date: January 2008
• Est. completion date: December 2032

Study information

• Verified date: April 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic-arthritis

Locations

Country	Name	City	State
Germany	Nationwide group of dermatological centers, hospitals and medical offices	Hamburg

Sponsors (20)

Lead Sponsor

Collaborator

Universitätsklinikum Hamburg-Eppendorf

AbbVie, Almirall Hermal GmbH, Amgen, Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de), Biogen, Bristol-Myers Squibb, Celgene, Deutsche Dermatologische Gesellschaft e.V. (https://derma.de), Eli Lilly and Company, Janssen-Cilag G.m.b.H, LEO Pharma, medac GmbH, Merck Serono GmbH, Germany, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer Pharmaceuticals Ltd., PsoNet.eu (http://www.psonet.eu/), UCB Pharma, Viatris Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse and serious adverse events	Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	6 month
Other	Patient Benefit Index (PBI)	To evaluate the patient benefit of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 3 months for 10 years
Other	EuroQol Questionnaire (EQ-5D)	To evaluate general state of health of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 3 months for 10 years
Other	Questionnaire on Supply Quality in Dermatology (FVQ-d)	To evaluate care characteristics of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 3 months for 10 years
Other	Health Assessment Questionnaire (HAQ)	To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 6 months for 10 years
Other	Patient Global Assessment (Skin: PaGAs, Arthritis: PaGAa)	To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 3 months for 10 years
Other	Physician Global Assessment (Skin: PGAs, Arthritis: PGAa)	To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 6 months for 10 years
Other	Disease Activity Score 28 (DAS 28), American College of Rheumatology Score (ACR20), Psoriatic Arthritic Response Criteria (PsARC)	To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 6 months for 10 years
Primary	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	Dermatology Life Quality Index (DLQI)	To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis	every 3 month for 10 years

External Links

•   German Center for Health Services Research in Dermatology
•   PsoBest - the German psoriasis registry
•   PsoNet - the European registry of psoriasis
•   Swiss Dermatology Network for Targeted Therapies (SDNTT)