Swiss Dermatology Network of Targeted Therapies (SDNTT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Swiss Dermatology Network for Targeted Therapies
Sponsor:
Information provided by (Responsible Party):
Swiss Dermatology Network for Targeted Therapies
ClinicalTrials.gov Identifier:
NCT01706692
First received: September 19, 2012
Last updated: October 12, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Swiss Dermatology Network for Targeted Therapies:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

Additional Information:
SDNTT  This link exits the ClinicalTrials.gov site

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 July 22, 2014