PsoriasisNCT01848028
PsoBest - The German Psoriasis Registry
An observational study of Psoriasis and Psoriatic-arthritis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic-arthritis
- How many people
- 3,500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Nationwide group of dermatological centers, hospitals and medical offices
Hamburg
Matthias Augustin, Prof. Dr., m.augustin@uke.de
Matthias Augustin, Prof. Dr.
About this study
Official title: Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
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.
Read the 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:
- Effectiveness in clinical practice ("real world")
- Benefits and needs on the patients' side
- Effectiveness in a long-term course over years
- Optimal maintenance dosages
- Safety and side-effects profile under routine conditions
- Use in case of and effect on co-morbidity
- Reliable predictors of response
- 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).
- Conditions
- Psoriasis, Psoriatic-arthritis
- Keywords
- patient registry, Germany, psoriasis, psoriatic-arthritis, biologics, Psonet, effectiveness, safety, biosimilars
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fumaric acid esters | Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, 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 and biosimilars: Etanercept, all dosages, frequencies and durations prescribed | |
| Infliximab | Intervention: Biological and Biosimilars/-identicals: Infliximab, all dosages, frequencies and durations prescribed | |
| Adalimumab | Intervention: Biological and Biosimilars: Adalimumab, all dosages, frequencies and durations prescribed | |
| Ustekinumab | Intervention: Biological and Biosimilars: 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 | |
| Guselkumab | Intervention: Biological: Guselkumab all dosages, frequencies and durations prescribed | |
| Brodalumab | Intervention: Biological: Brodalumab, all dosages, frequencies and durations prescribed | |
| Tildrakizumab | Intervention: Biological: Tildrakizumab, all dosages, frequencies and durations prescribed | |
| Risankizumab | Intervention: Biological: systemic Risankizumab, all dosages, frequencies and durations prescribed | |
| Bimekizumab | Intervention: Biological: Bimekizumab, all dosages, frequencies and durations prescribed | |
| Tofacitinib | Intervention: JAK-Inhibitor: Tofacitinib, all dosages, frequencies and durations prescribed | |
| Upadacitinib | Intervention: JAK-Inhibitor: Upadacitinib, all dosages, frequencies and durations prescribed | |
| Deucravacitinib | Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed | |
| Ixekizumab | Intervention: Biological: Ixekizumab, all dosages, frequencies and durations prescribed | |
| No treatment | Intervention: no systemic treatment in observation episodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area Severity Index (PASI)
To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Measured: every 6 month for 10 years
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI)
To evaluate disease related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Measured: every 3 month for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de), Deutsche Dermatologische Gesellschaft e.V. (https://derma.de), AbbVie, Biogen, Janssen-Cilag G.m.b.H, medac GmbH, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer Pharmaceuticals Ltd., Merck Serono GmbH, Germany, PsoNet.eu (http://www.psonet.eu/), Celgene, Eli Lilly and Company, Amgen, Almirall Hermal GmbH, UCB Pharma, Bristol-Myers Squibb, Viatris Inc., LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Matthias Augustin, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848028
- Sponsor's protocol ID
- IVDP-085-07
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2013
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
- ClinicalTrials.gov ID
- NCT01848028
- Acronym / sponsor ID
- IVDP-085-07
- Conditions
- Psoriasis, Psoriatic-arthritis
- Keywords
- patient registry, Germany, psoriasis, psoriatic-arthritis, biologics, Psonet, effectiveness, safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Berufsverband der Deutschen Dermatologen e.V. (www.bvdd.de), Deutsche Dermatologische Gesellschaft e.V. (https://derma.de), AbbVie, Biogen, Janssen-Cilag G.m.b.H, medac GmbH, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, Pfizer Pharmaceuticals Ltd., Merck Serono GmbH, Germany, PsoNet.eu (http://www.psonet.eu/), Celgene, Eli Lilly and Company, Amgen, Almirall Hermal GmbH, UCB Pharma, Bristol-Myers Squibb, Viatris Inc., LEO Pharma
- Study start
- Jan 2008
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Effectiveness in clinical practice ("real world")
- Benefits and needs on the patients' side
- Effectiveness in a long-term course over years
- Optimal maintenance dosages
- Safety and side-effects profile under routine conditions
- Use in case of and effect on co-morbidity
- Reliable predictors of response
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 25
| Arm | Type | Receives |
|---|---|---|
| Fumaric acid esters | – | –Intervention: Drug: conventional systemic: Fumaric acid esters, including Dimethylfumarate, 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 and biosimilars: Etanercept, all dosages, frequencies and durations prescribed |
| Infliximab | – | –Intervention: Biological and Biosimilars/-identicals: Infliximab, all dosages, frequencies and durations prescribed |
| Adalimumab | – | –Intervention: Biological and Biosimilars: Adalimumab, all dosages, frequencies and durations prescribed |
| Ustekinumab | – | –Intervention: Biological and Biosimilars: 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 |
| Guselkumab | – | –Intervention: Biological: Guselkumab all dosages, frequencies and durations prescribed |
| Brodalumab | – | –Intervention: Biological: Brodalumab, all dosages, frequencies and durations prescribed |
| Tildrakizumab | – | –Intervention: Biological: Tildrakizumab, all dosages, frequencies and durations prescribed |
| Risankizumab | – | –Intervention: Biological: systemic Risankizumab, all dosages, frequencies and durations prescribed |
| Bimekizumab | – | –Intervention: Biological: Bimekizumab, all dosages, frequencies and durations prescribed |
| Tofacitinib | – | –Intervention: JAK-Inhibitor: Tofacitinib, all dosages, frequencies and durations prescribed |
| Upadacitinib | – | –Intervention: JAK-Inhibitor: Upadacitinib, all dosages, frequencies and durations prescribed |
| Deucravacitinib | – | –Intervention: JAK-Inhibitor: Deucravacitinib, all dosages, frequencies and durations prescribed |
| Ixekizumab | – | –Intervention: Biological: Ixekizumab, all dosages, frequencies and durations prescribed |
| No treatment | – | –Intervention: no systemic treatment in observation episodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with plaque-type psoriasis or psoriatic-arthritis starting the first systemic treatment with authorized atipsoriatic drugs in Germany.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Dermatology Life Quality Index (DLQI)
Time frame: every 3 month for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- PsoBest - the German psoriasis registryLink provided by the sponsor.
- German Center for Health Services Research in DermatologyLink provided by the sponsor.
- PsoNet - the European registry of psoriasisLink provided by the sponsor.
- Swiss Dermatology Network for Targeted Therapies (SDNTT)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nationwide group of dermatological centers, hospitals and medical offices
Hamburg, Germany
Matthias Augustin, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Psoriatic-arthritis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area Severity Index (PASI) (time frame: every 6 month for 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.