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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275PSO4028; AG110401-IIR | Other Grant/Funding Number | AbbVie, Almirall, Janssen Pharmaceutica, Eli Lilly, UCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Intervention: Biological: Adalimumab, 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 |
| |
| Ustekinumab | Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed |
| |
| Cyclosporine A | Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed |
| |
| Fumaric acids | Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | all dosages, frequencies and durations prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index (PASI) | To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | every 6 months for 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | every 6 months for 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse and serious adverse events | Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis | 10 years |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Navarini, Prof Dr med | Swiss Society of Dermatology and Venereology (SSDV) | Principal Investigator |
| Julia-Tatjana Maul, PD Dr med | Swiss Society of Dermatology and Venereology (SSDV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarau Cantonal Hospital | Recruiting | Aarau | CH-5001 | Switzerland |
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| Label | URL |
|---|---|
| SDNTT | View source |
| German registry PsoBest | View source |
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|
| Methotrexate | Intervention: Drug: conventional systemic: 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 |
|
| Etanercept | Biological | all dosages, frequencies and durations prescribed |
|
|
| Infliximab | Biological | all dosages, frequencies and durations prescribed |
|
|
| Ustekinumab | Biological | all dosages, frequencies and durations prescribed |
|
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| Cyclosporine A | Drug | all dosages, frequencies and durations prescribed |
|
| Fumaric acids | Drug | all dosages, frequencies and durations prescribed |
|
| Methotrexate | Drug | all dosages, frequencies and durations prescribed |
|
| Other anti-psoriatic systemic treatments | Drug | all dosages, frequencies and durations prescribed |
|
| Basel University Hospital | Recruiting | Basel | CH-4031 | Switzerland |
|
| Inselspital - Bern University Hospital | Recruiting | Bern | CH-3001 | Switzerland |
|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | CH-1011 | Switzerland |
|
| St. Gallen Cantonal Hospital | Recruiting | Sankt Gallen | CH-9007 | Switzerland |
|
| Zurich University Hospital | Recruiting | Zurich | CH-8091 | Switzerland |
|
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| D000069285 | Infliximab |
| D000069549 | Ustekinumab |
| D016572 | Cyclosporine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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