Clinical trial NCT01848028: PsoBest - The German Psoriasis Registry
Official title: Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Psoriatic-arthritis
Keywords: patient registry
Germany
psoriasis
psoriatic-arthritis
biologics
Psonet
effectiveness
safety
biosimilars
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de)
name: Deutsche Dermatologische Gesellschaft e.V. (https://derma.de)
name: AbbVie
name: Biogen
name: Janssen-Cilag G.m.b.H
name: medac GmbH
name: Merck Sharp & Dohme LLC
name: Novartis Pharmaceuticals
name: Pfizer Pharmaceuticals Ltd.
name: Merck Serono GmbH, Germany
name: PsoNet.eu (http://www.psonet.eu/)
name: Celgene
name: Eli Lilly and Company
name: Amgen
name: Almirall Hermal GmbH
name: UCB Pharma
name: Bristol-Myers Squibb
name: Viatris Inc.
name: LEO Pharma
First posted: 2013-05-07
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.

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.

Detailed 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).

Eligibility 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)

Primary outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: every 6 month for 10 years
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: every 3 month for 10 years
Other outcomes:
measure: Adverse and serious adverse events
timeFrame: 6 month
measure: Patient Benefit Index (PBI)
timeFrame: every 3 months for 10 years
measure: EuroQol Questionnaire (EQ-5D)
timeFrame: every 3 months for 10 years
measure: Questionnaire on Supply Quality in Dermatology (FVQ-d)
timeFrame: every 3 months for 10 years
measure: Health Assessment Questionnaire (HAQ)
timeFrame: every 6 months for 10 years
measure: Patient Global Assessment (Skin: PaGAs, Arthritis: PaGAa)
timeFrame: every 3 months for 10 years
measure: Physician Global Assessment (Skin: PGAs, Arthritis: PGAa)
timeFrame: every 6 months for 10 years
measure: Disease Activity Score 28 (DAS 28), American College of Rheumatology Score (ACR20), Psoriatic Arthritic Response Criteria (PsARC)
timeFrame: every 6 months for 10 years
Locations:
city: Hamburg
country: Germany
facility: Nationwide group of dermatological centers, hospitals and medical offices
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Matthias Augustin, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: