PsoBest - The German Psoriasis Registry

NCT01848028

Last updated date
Study Location
Nationwide group of dermatological centers, hospitals and medical offices
Hamburg, , , Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis, Psoriatic-arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Psoriasis, Psoriatic-arthritisPsoBest - The German Psoriasis Registry
NCT01848028
  1. Hamburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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