Psoriasis Clinical Trial in Lausanne
NCT01706692
| Observational
This study is looking to recruit 750 Participants
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.
Details for the 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.
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<br /> psoriatic-arthritis in systemic treatments such as, methotrexate, cyclosporin A, fumaric<br /> acids, acitretin, systemic PUVA, etanercept, infliximab, adalimumab and ustekinumab. A<br /> patient will be included at first initiation of the treatment and will remain in the registry<br /> for 10 years, regardless of subsequent therapy.<br /><br /> 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.
Treatments and/or Procedures
Etanercept
all dosages, frequencies and durations prescribed
Adalimumab
all dosages, frequencies and durations prescribed
Ustekinumab
all dosages, frequencies and durations prescribed
Infliximab
all dosages, frequencies and durations prescribed
Cyclosporine A
all dosages, frequencies and durations prescribed
Fumaric acids
all dosages, frequencies and durations prescribed
Methotrexate
all dosages, frequencies and durations prescribed
Other anti psoriatic systemic treatments
all dosages, frequencies and durations prescribed
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Psoriasis Area Severity Index (PASI)
To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis
Secondary
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
Other
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
Study 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)