PsoBest - The German Psoriasis Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Collaborators:
Berufsverband der Deutschen Dermatologen e.V. (BVDD)
Deutsche Dermatologische Gesellschaft e.V. (DDG)
AbbVie
Biogen Idec
Janssen-Cilag GmbH
medac GmbH
Merck Sharp & Dohme Corp.
Novartis Pharmaceuticals
Pfizer Deutschland GmbH
Serono GmbH (former collaborator)
PsoNet.eu
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01848028
First received: April 7, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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 While efalizumab was withdrawn from the market, ustekinumab was included after authorization.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).


Condition
Psoriasis
Psoriatic-arthritis

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 month for 5 years ] [ Designated as safety issue: No ]
    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Secondary Outcome Measures:
  • Dermatology Life Quality Index (DLQI) [ Time Frame: every 3 month for 5 years ] [ Designated as safety issue: No ]
    To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Other Outcome Measures:
  • Adverse and serious adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To evaluate arthritis severity of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Estimated Enrollment: 3500
Study Start Date: January 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848028

Locations
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 Idec
Janssen-Cilag GmbH
medac GmbH
Merck Sharp & Dohme Corp.
Novartis Pharmaceuticals
Pfizer Deutschland GmbH
Serono GmbH (former collaborator)
PsoNet.eu
Investigators
Principal Investigator: Matthias Augustin, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01848028     History of Changes
Other Study ID Numbers: 0741/118
Study First Received: April 7, 2013
Last Updated: April 29, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Patient registry
Germany
Psoriasis
psoriatic-arthritis
Efalizumab
Psonet
Effectiveness
Safety

Additional relevant MeSH terms:
Psoriasis
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014