Swiss Dermatology Network of Targeted Therapies (SDNTT)
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Purpose
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 5 years, regardless of subsequent therapy.
The registry will also evaluate safety clinical outcomes and health related quality of life.
| Condition | Intervention |
|---|---|
|
Psoriasis |
Biological: Adalimumab Biological: Etanercept Biological: Infliximab Biological: Ustekinumab Drug: Cyclosporine A Drug: Fumaric acids Drug: Methotrexate Drug: Other anti-psoriatic systemic treatments |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics |
- Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 months 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
- Dermatology Life Quality Index (DLQI) [ Time Frame: every 6 months for 5 years ] [ Designated as safety issue: No ]To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
- Adverse and serious adverse events [ Time Frame: 5 years ] [ 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
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2021 |
| Estimated Primary Completion Date: | June 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Adalimumab
Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed
|
Biological: Adalimumab
all dosages, frequencies and durations prescribed
Other Name: Humira
|
|
Etanercept
Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed
|
Biological: Etanercept
all dosages, frequencies and durations prescribed
Other Name: Enbrel
|
|
Infliximab
Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed
|
Biological: Infliximab
all dosages, frequencies and durations prescribed
Other Name: Remicade
|
|
Ustekinumab
Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed
|
Biological: Ustekinumab
all dosages, frequencies and durations prescribed
Other Name: Stelara
|
|
Cyclosporine A
Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed
|
Drug: Cyclosporine A
all dosages, frequencies and durations prescribed
|
|
Fumaric acids
Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed
|
Drug: Fumaric acids
all dosages, frequencies and durations prescribed
|
|
Methotrexate
Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed
|
Drug: Methotrexate
all dosages, frequencies and durations prescribed
|
|
Other anti-psoriatic systemic treatments
e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed
|
Drug: Other anti-psoriatic systemic treatments
all dosages, frequencies and durations prescribed
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations| Switzerland | |
| Aarau Cantonal Hospital | Recruiting |
| Aarau, Switzerland, CH-5001 | |
| Contact: Marcus Streit, Dr. med. 062 838 68 38 markus.streit@ksa.ch | |
| Principal Investigator: Marcus Streit, Dr. med. | |
| Basel University Hospital | Recruiting |
| Basel, Switzerland, CH-4031 | |
| Contact: Peter Itin, Prof. pitin@uhbs.ch | |
| Principal Investigator: Peter Itin, Prof. | |
| Inselspital - Bern University Hospital | Recruiting |
| Bern, Switzerland, CH-3001 | |
| Contact: Luca Borradori, Prof. Dr. 031 632 2111 Luca.Borradori@insel.ch | |
| Principal Investigator: Luca Borradori, Prof. Dr. | |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting |
| Lausanne, Switzerland, CH-1011 | |
| Contact: Michel Gilliet, Prof. michel.gilliet@chuv.ch | |
| Principal Investigator: Curdin Conrad, PD Dr. med. | |
| St. Gallen Cantonal Hospital | Recruiting |
| St. Gallen, Switzerland, CH-9007 | |
| Contact: Damian Bühler, Dr. med. damian.buehler@kssg.ch | |
| Principal Investigator: Mark Anliker, Dr. med. | |
| Zurich University Hospital | Recruiting |
| Zurich, Switzerland, CH-8091 | |
| Contact: Alexander Navarini, Dr. alexander.navarini@usz.ch | |
| Principal Investigator: Lars French, Prof. | |
| Principal Investigator: | Lars French, Prof Dr med | Swiss Society of Dermatology and Venereology (SSDV) |
| Principal Investigator: | Peter Itin, Prof Dr med | Swiss Society of Dermatology and Venereology (SSDV) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Swiss Dermatology Network for Targeted Therapies |
| ClinicalTrials.gov Identifier: | NCT01706692 History of Changes |
| Other Study ID Numbers: | IMM 10-0138; P21007224R, CNTO1275PSO4028; AG110401-IIR |
| Study First Received: | September 19, 2012 |
| Last Updated: | October 12, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by Swiss Dermatology Network for Targeted Therapies:
|
Methotrexate Acitretin Cyclosporine A Systemic PUVA Infliximab Adalimumab |
Etanercept Ustekinumab Fumaric acids Psoriasis Psoriatic arthritis Skin disease |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Cyclosporins Cyclosporine Methotrexate TNFR-Fc fusion protein Infliximab Adalimumab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on May 19, 2013