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Swiss Dermatology Network of Targeted Therapies (SDNTT) (SDNTT)

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ClinicalTrials.gov Identifier: NCT01706692
Recruitment Status : Recruiting
First Posted : October 15, 2012
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Swiss Dermatology Network for Targeted Therapies

Brief 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. 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 or disease Intervention/treatment
Psoriasis Biological: Adalimumab Biological: Etanercept Biological: Infliximab Biological: Ustekinumab Drug: Cyclosporine A Drug: Fumaric acids Drug: Methotrexate Drug: Other anti-psoriatic systemic treatments

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 Type : Observational
Estimated Enrollment : 500 participants
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
Study Start Date : July 2011
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Psoriasis Area Severity Index (PASI) [ Time Frame: every 6 months for 5 years ]
    To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Secondary Outcome Measures :
  1. Dermatology Life Quality Index (DLQI) [ Time Frame: every 6 months for 5 years ]
    To evaluate health related quality of life of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis


Other Outcome Measures:
  1. Adverse and serious adverse events [ Time Frame: 5 years ]
    Risk for adverse events and serious adverse events for patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706692


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.         
Sponsors and Collaborators
Swiss Dermatology Network for Targeted Therapies
Investigators
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)

Additional Information:
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 ( Other Grant/Funding Number: Abbott, Janssen Pharmaceutica, MSD-Chibret, )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

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
Methotrexate
Cyclosporine
Infliximab
Ustekinumab
Cyclosporins
Etanercept
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal