PsoriasisSDNTTNCT01706692
Swiss Dermatology Network of Targeted Therapies (SDNTT)
An observational study of Psoriasis, run by Swiss Dermatology Network for Targeted Therapies at 6 sites in Switzerland.
Trial summary
The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab, Etanercept and Infliximab
- How many people
- 1,121 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Feb 2011to 15 Mar 2032
- 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: Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not meeting the exclusion criteria will be eligible to participate in this registry.
Who may be able to join
- Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist,
- age ≥ 18,
- Being administered a specific biologic/conventional systemic drug for the first time
- Sufficient language skills (German, French, Italian and English) for the informed consent to participate
- Informed consent to participate
Who cannot join
- Lack of informed consent
- Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Switzerland6 sites, 6 recruiting
- Recruiting
Aarau Cantonal Hospital
Aarau, CH-5001
Marcus Streit, Dr. med., 062 838 68 38, markus.streit@ksa.ch
Marcus Streit, Dr. med.
- Recruiting
Basel University Hospital
Basel, CH-4031
Alexander Navarini, Prof., Alexander.Navarini@usb.ch
Alexander Navarini, Prof.
- Recruiting
Inselspital - Bern University Hospital
Bern, CH-3001
Luca Borradori, Prof., 031 632 2111, Luca.Borradori@insel.ch
Nikhil Yawalkar, Prof.
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, CH-1011
Michel Gilliet, Prof., michel.gilliet@chuv.ch
Curdin Conrad, PD Dr. med.
- Recruiting
St. Gallen Cantonal Hospital
Sankt Gallen, CH-9007
Antonio Cozzio, Prof., Antonio.Cozzio@kssg.ch
Antonio Cozzio, Prof.
- Recruiting
Zurich University Hospital
Zurich, CH-8091
Tatjana Maul, PD Dr., Julia-Tatjana.Maul@usz.ch
Tatjana Maul, Dr.
About this study
Official title: Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.
The registry will also evaluate safety clinical outcomes and health related quality of life.
Read the detailed description
Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. 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. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.
The study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 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.
- Conditions
- Psoriasis
- Being tested
- Adalimumab, Etanercept, Infliximab, Ustekinumab, Cyclosporine A
- Keywords
- Methotrexate, Acitretin, Cyclosporine A, Systemic PUVA, Infliximab, Adalimumab, Etanercept, Ustekinumab, Fumaric acids, Psoriasis, Psoriatic arthritis, Skin disease
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira
all dosages, frequencies and durations prescribed
EtanerceptBiological
Also called Enbrel
all dosages, frequencies and durations prescribed
InfliximabBiological
Also called Remicade
all dosages, frequencies and durations prescribed
UstekinumabBiological
Also called Stelara
all dosages, frequencies and durations prescribed
Cyclosporine ADrug
all dosages, frequencies and durations prescribed
Fumaric acidsDrug
all dosages, frequencies and durations prescribed
MethotrexateDrug
all dosages, frequencies and durations prescribed
Other anti-psoriatic systemic treatmentsDrug
all dosages, frequencies and durations prescribed
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed Receives: Biological: Adalimumab | |
| Etanercept | Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed Receives: Biological: Etanercept | |
| Infliximab | Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed Receives: Biological: Infliximab | |
| Ustekinumab | Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed Receives: Biological: Ustekinumab | |
| Cyclosporine A | Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed Receives: Drug: Cyclosporine A | |
| Fumaric acids | Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed Receives: Drug: Fumaric acids | |
| Methotrexate | Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed Receives: Drug: Methotrexate | |
| Other anti-psoriatic systemic treatments | e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed Receives: Drug: Other anti-psoriatic systemic treatments |
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 months for 10 years
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI)
To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Measured: every 6 months 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 posted15 Oct 2012 (estimated)
- Study startFeb 2011
- Primary completion15 Mar 2032 (estimated)
- Study completion15 Mar 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
- 1,121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Dermatology Network for Targeted Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Navarini, Prof Dr med, Principal investigator, Swiss Society of Dermatology and Venereology (SSDV)Julia-Tatjana Maul, PD Dr med, Principal investigator, Swiss Society of Dermatology and Venereology (SSDV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706692
- Sponsor's protocol ID
- IMM 10-0138; P21007224R
- Other IDs
- CNTO1275PSO4028; AG110401-IIR
- Acronym
- SDNTT
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2012
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
- ClinicalTrials.gov ID
- NCT01706692
- Acronym / sponsor ID
- SDNTT / IMM 10-0138; P21007224R
- Conditions
- Psoriasis
- Keywords
- Methotrexate, Acitretin, Cyclosporine A, Systemic PUVA, Infliximab, Adalimumab, Etanercept, Ustekinumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,121 participants (estimated)
- Lead sponsor
- Swiss Dermatology Network for Targeted TherapiesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- 15 Mar 2032 (estimated)
- Study completion
- 15 Mar 2032 (estimated)
- First posted
- 15 Oct 2012 (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.
The purpose of this study is to evaluate the long-term course of patients with psoriasis and psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A patient will be included at first initiation of the treatment and will remain in the registry for 10 years, regardless of subsequent therapy.
The registry will also evaluate safety clinical outcomes and health related quality of life.
Detailed description
Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) in Switzerland is largely performed with systemic therapies. This includes conventional systemic therapy such as fumaric acids, methotrexate, cyclosporin A, retinoids, systemic PUVA, Acitretin and biological treatments such as etanercept, infliximab, adalimumab and within a pre-registration program ustekinumab. 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. SDNTT, the Swiss registry on the treatment of moderate to severe Pso and PsA documents the long-term course of patients being administered a defined biologic or conventional systemic drug. Following outcomes are observed: Effectiveness on the long-term, of combined/alternating treatments and under comorbidity conditions; patient-defined benefits and quality of life, maintenance dosages, prediction of response and safety.
The study evaluates the long-term course of patients with Pso and PsA in systemic treatments. A patient will be included at first initiation of the treatment and will remain in the registry for 5 years, regardless of subsequent therapy. Nationwide, initially 35 (long-term approx. 50-80) dermatologic practices and hospital ambulances with expertise in systemic and biologic treatment will consecutively enroll patients. Follow-ups will be every 3 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | Biological: AdalimumabIntervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed |
| Etanercept | – | Biological: EtanerceptIntervention: Biological: Etanercept, all dosages, frequencies and durations prescribed |
| Infliximab | – | Biological: InfliximabIntervention: Biological: Infliximab, all dosages, frequencies and durations prescribed |
| Ustekinumab | – | Biological: UstekinumabIntervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed |
| Cyclosporine A | – | Drug: Cyclosporine AIntervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed |
| Fumaric acids | – | Drug: Fumaric acidsIntervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed |
| Methotrexate | – | Drug: MethotrexateIntervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed |
| Other anti-psoriatic systemic treatments | – | Drug: Other anti-psoriatic systemic treatmentse.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with psoriasis or psoriatic-arthritis meeting the inclusion criteria and not meeting the exclusion criteria will be eligible to participate in this registry.
Key inclusion criteria (5 listed)
- Patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist,
- age ≥ 18,
- Being administered a specific biologic/conventional systemic drug for the first time
- Sufficient language skills (German, French, Italian and English) for the informed consent to participate
- Informed consent to participate
Key exclusion criteria (2 listed)
- Lack of informed consent
- Patients being participants of clinical trials at the day of registration to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analyzed separately)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humiraall dosages, frequencies and durations prescribed | Biological | Adalimumab |
| EtanerceptAlso: Enbrelall dosages, frequencies and durations prescribed | Biological | Etanercept |
| InfliximabAlso: Remicadeall dosages, frequencies and durations prescribed | Biological | Infliximab |
| UstekinumabAlso: Stelaraall dosages, frequencies and durations prescribed | Biological | Ustekinumab |
| Cyclosporine Aall dosages, frequencies and durations prescribed | Drug | Cyclosporine A |
| Fumaric acidsall dosages, frequencies and durations prescribed | Drug | Fumaric acids |
| Methotrexateall dosages, frequencies and durations prescribed | Drug | Methotrexate |
| Other anti-psoriatic systemic treatmentsall dosages, frequencies and durations prescribed | Drug | Other anti-psoriatic systemic treatments |
Primary outcome
Psoriasis Area Severity Index (PASI)
Time frame: every 6 months 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 6 months 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 29 Nov 2024.
- SDNTTLink provided by the sponsor.
- German registry PsoBestLink provided by the sponsor.
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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.
Alexander Navarini, Prof Dr med principal investigator
Swiss Society of Dermatology and Venereology (SSDV)
Julia-Tatjana Maul, PD Dr med principal investigator
Swiss Society of Dermatology and Venereology (SSDV)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Swiss Dermatology Network for Targeted Therapies at 6 sites in Switzerland.
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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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 months 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 29 Nov 2024.