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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 : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Dermatology Network for Targeted Therapies

Tracking Information
First Submitted Date September 19, 2012
First Posted Date October 15, 2012
Last Update Posted Date April 9, 2019
Study Start Date July 2011
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2012)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01706692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 12, 2012)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2012)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Swiss Dermatology Network of Targeted Therapies (SDNTT)
Official Title Long-Term Benefits and Safety of Systemic Psoriasis Therapy: Swiss Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psoriasis
Intervention
  • Biological: Adalimumab
    all dosages, frequencies and durations prescribed
    Other Name: Humira
  • Biological: Etanercept
    all dosages, frequencies and durations prescribed
    Other Name: Enbrel
  • Biological: Infliximab
    all dosages, frequencies and durations prescribed
    Other Name: Remicade
  • Biological: Ustekinumab
    all dosages, frequencies and durations prescribed
    Other Name: Stelara
  • Drug: Cyclosporine A
    all dosages, frequencies and durations prescribed
  • Drug: Fumaric acids
    all dosages, frequencies and durations prescribed
  • Drug: Methotrexate
    all dosages, frequencies and durations prescribed
  • Drug: Other anti-psoriatic systemic treatments
    all dosages, frequencies and durations prescribed
Study Groups/Cohorts
  • Adalimumab
    Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed
    Intervention: Biological: Adalimumab
  • Etanercept
    Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed
    Intervention: Biological: Etanercept
  • Infliximab
    Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed
    Intervention: Biological: Infliximab
  • Ustekinumab
    Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed
    Intervention: Biological: Ustekinumab
  • Cyclosporine A
    Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed
    Intervention: Drug: Cyclosporine A
  • Fumaric acids
    Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed
    Intervention: Drug: Fumaric acids
  • Methotrexate
    Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed
    Intervention: Drug: Methotrexate
  • Other anti-psoriatic systemic treatments
    e.g.: Intervention: Drug: conventional systemic: Acitretin or Systemic phototherapy (PUVA), all dosages, frequencies and durations prescribed
    Intervention: Drug: Other anti-psoriatic systemic treatments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 12, 2012)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01706692
Other Study ID Numbers IMM 10-0138; P21007224R
CNTO1275PSO4028; AG110401-IIR ( Other Grant/Funding Number: Abbott, Janssen Pharmaceutica, MSD-Chibret, )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Swiss Dermatology Network for Targeted Therapies
Study Sponsor Swiss Dermatology Network for Targeted Therapies
Collaborators Not Provided
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)
PRS Account Swiss Dermatology Network for Targeted Therapies
Verification Date April 2019