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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 Corp.
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

Tracking Information
First Submitted Date April 7, 2013
First Posted Date May 7, 2013
Last Update Posted Date May 17, 2019
Study Start Date January 2008
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2014)
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
Original Primary Outcome Measures
 (submitted: May 2, 2013)
Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 month for 5 years ]
To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Change History Complete list of historical versions of study NCT01848028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2014)
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
Original Secondary Outcome Measures
 (submitted: May 2, 2013)
Dermatology Life Quality Index (DLQI) [ Time Frame: every 3 month for 5 years ]
To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Current Other Pre-specified Outcome Measures
 (submitted: August 27, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: May 2, 2013)
  • 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
  • Patient Benefit Index (PBI) [ Time Frame: every 3 months for 5 years ]
    To evaluate the patient benefit of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • EuroQol Questionnaire (EQ-5D) [ Time Frame: every 3 months for 5 years ]
    To evaluate general state of health of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • Questionnaire on Supply Quality in Dermatology (FVQ-d) [ Time Frame: every 3 months for 5 years ]
    To evaluate care characteristics of conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • Health Assessment Questionnaire (HAQ) [ Time Frame: every 6 months for 5 years ]
    To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • Patient Global Assessment (Skin: PaGAs, Arthritis: PaGAa) [ Time Frame: every 3 months for 5 years ]
    To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • Physician Global Assessment (Skin: PGAs, Arthritis: PGAa) [ Time Frame: every 6 months for 5 years ]
    To evaluate global severity of skin and arthritis in patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
  • Disease Activity Score 28 (DAS 28), American College of Rheumatology Score (ACR20), Psoriatic Arthritic Response Criteria (PsARC) [ Time Frame: every 6 months for 5 years ]
    To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
 
Descriptive Information
Brief Title 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
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).

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition
  • Psoriasis
  • Psoriatic-arthritis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2013)
3500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01848028
Other Study ID Numbers IVDP-085-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
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 Corp.
  • Novartis Pharmaceuticals
  • Pfizer Deutschland GmbH
  • Serono GmbH (former collaborator)
  • PsoNet.eu
  • Celgene Corporation
  • Eli Lilly and Company
Investigators
Principal Investigator: Matthias Augustin, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date May 2019