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PsoBest - The German Psoriasis Registry

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ClinicalTrials.gov Identifier: NCT01848028
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
Berufsverband der Deutschen Dermatologen e.V. (BVDD)
Deutsche Dermatologische Gesellschaft e.V. (DDG)
AbbVie
Biogen
Janssen-Cilag G.m.b.H
medac GmbH
Merck Sharp & Dohme LLC
Novartis Pharmaceuticals
Pfizer Deutschland GmbH
Serono GmbH (former collaborator)
PsoNet.eu
Celgene Corporation
Eli Lilly and Company
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease
Psoriasis Psoriatic-arthritis

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).

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
Study Start Date : January 2008
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Fumaric acid ester
Intervention: Drug: conventional systemic: Fumaric acid ester, 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: Etanercept, all dosages, frequencies and durations prescribed
Infliximab
Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed
Adalimumab
Intervention: Biological: 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


Outcome Measures
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Primary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 month for 10 years ]
    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Secondary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: every 3 month for 10 years ]
    To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Other Outcome Measures:
  1. Adverse and serious adverse events [ Time Frame: 6 month ]
    Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  2. Patient Benefit Index (PBI) [ Time Frame: every 3 months for 10 years ]
    To evaluate the patient benefit of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  3. EuroQol Questionnaire (EQ-5D) [ Time Frame: every 3 months for 10 years ]
    To evaluate general state of health of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  4. Questionnaire on Supply Quality in Dermatology (FVQ-d) [ Time Frame: every 3 months for 10 years ]
    To evaluate care characteristics of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  5. Health Assessment Questionnaire (HAQ) [ Time Frame: every 6 months for 10 years ]
    To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  6. Patient Global Assessment (Skin: PaGAs, Arthritis: PaGAa) [ Time Frame: every 3 months for 10 years ]
    To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  7. Physician Global Assessment (Skin: PGAs, Arthritis: PGAa) [ Time Frame: every 6 months for 10 years ]
    To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  8. Disease Activity Score 28 (DAS 28), American College of Rheumatology Score (ACR20), Psoriatic Arthritic Response Criteria (PsARC) [ Time Frame: every 6 months for 10 years ]
    To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848028


Locations
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Germany
Nationwide group of dermatological centers, hospitals and medical offices Recruiting
Hamburg, Germany
Contact: Matthias Augustin, Prof. Dr.       m.augustin@uke.de   
Principal Investigator: Matthias Augustin, Prof. Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Berufsverband der Deutschen Dermatologen e.V. (BVDD)
Deutsche Dermatologische Gesellschaft e.V. (DDG)
AbbVie
Biogen
Janssen-Cilag G.m.b.H
medac GmbH
Merck Sharp & Dohme LLC
Novartis Pharmaceuticals
Pfizer Deutschland GmbH
Serono GmbH (former collaborator)
PsoNet.eu
Celgene Corporation
Eli Lilly and Company
Investigators
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Principal Investigator: Matthias Augustin, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
More Information
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Additional Information:

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01848028    
Other Study ID Numbers: IVDP-085-07
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Patient registry
Germany
Psoriasis
psoriatic-arthritis
 Efalizumab
Psonet
Effectiveness
Safety
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
 Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases