Actively Recruiting
Long-Term Study of Systemic Treatments for Moderate to Severe Psoriasis and Psoriatic Arthritis Evaluation of Biologics and Conventional Therapies in a German Patient Registry
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-01-27
3500
Participants Needed
1
Research Sites
1300 weeks
Total Duration
On this page
Sponsors
U
Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor
B
Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the long-term outcomes and effectiveness of systemic treatments for moderate to severe Psoriasis and Psoriatic Arthritis in Germany. These treatments include conventional systemic drugs like fumaric acids, methotrexate, and ciclosporin A, as well as biological therapies such as adalimumab and etanercept. While short- and mid-term results of these therapies are known, this study aims to gather more information about their long-term benefits, safety, optimal dosages, and effects in real-world clinical settings. The study is conducted through the German PsoBest registry, which began in 2008 and tracks the treatment of 3,500 patients using any biologic or conventional systemic antipsoriatic drug authorized in Germany. Patients are enrolled when they start a new systemic treatment and are followed for five years, regardless of any changes in therapy. Follow-ups occur every 3 to 6 months and include detailed questionnaires completed by both patients and dermatologists, as well as periodic patient contact by mail. Participants will undergo regular assessments including clinical evaluations, patient-reported benefits, quality of life measures, and monitoring for side effects. The main outcome measured is the Psoriasis Area Severity Index (PASI), which will be recorded every six months for up to ten years. This comprehensive monitoring helps researchers understand the long-term effectiveness, safety, and patient experiences with systemic psoriasis treatments in everyday medical practice.
CONDITIONS
Official Title
PsoBest - The German Psoriasis Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of plaque-type psoriasis or psoriatic arthritis confirmed by a dermatologist
- Age 18 years or older
- Starting a specific systemic drug for psoriasis treatment for the first time
- Provided informed consent to participate
- Have sufficient German language skills
You will not qualify if you...
- Lack of informed consent
- Currently participating in a clinical trial at the time of registry enrollment (data from patients who join a clinical trial during follow-up will be recorded but analyzed separately)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nationwide group of dermatological centers, hospitals and medical offices
Hamburg, Germany
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
25
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