Swiss Dermatology Network of Targeted Therapies (SDNTT)

NCT ID: NCT01706692

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2032-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab

Intervention: Biological: Adalimumab, all dosages, frequencies and durations prescribed

Adalimumab

Intervention Type BIOLOGICAL

all dosages, frequencies and durations prescribed

Etanercept

Intervention: Biological: Etanercept, all dosages, frequencies and durations prescribed

Etanercept

Intervention Type BIOLOGICAL

all dosages, frequencies and durations prescribed

Infliximab

Intervention: Biological: Infliximab, all dosages, frequencies and durations prescribed

Infliximab

Intervention Type BIOLOGICAL

all dosages, frequencies and durations prescribed

Ustekinumab

Intervention: Biological: Ustekinumab, all dosages, frequencies and durations prescribed

Ustekinumab

Intervention Type BIOLOGICAL

all dosages, frequencies and durations prescribed

Cyclosporine A

Intervention: Drug: conventional systemic: Cyclosporine A, all dosages, frequencies and durations prescribed

Cyclosporine A

Intervention Type DRUG

all dosages, frequencies and durations prescribed

Fumaric acids

Intervention: Drug: conventional systemic: Fumaric acids, all dosages, frequencies and durations prescribed

Fumaric acids

Intervention Type DRUG

all dosages, frequencies and durations prescribed

Methotrexate

Intervention: Drug: conventional systemic: Methotrexate, all dosages, frequencies and durations prescribed

Methotrexate

Intervention Type DRUG

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

Other anti-psoriatic systemic treatments

Intervention Type DRUG

all dosages, frequencies and durations prescribed

Interventions

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Adalimumab

all dosages, frequencies and durations prescribed

Intervention Type BIOLOGICAL

Etanercept

all dosages, frequencies and durations prescribed

Intervention Type BIOLOGICAL

Infliximab

all dosages, frequencies and durations prescribed

Intervention Type BIOLOGICAL

Ustekinumab

all dosages, frequencies and durations prescribed

Intervention Type BIOLOGICAL

Cyclosporine A

all dosages, frequencies and durations prescribed

Intervention Type DRUG

Fumaric acids

all dosages, frequencies and durations prescribed

Intervention Type DRUG

Methotrexate

all dosages, frequencies and durations prescribed

Intervention Type DRUG

Other anti-psoriatic systemic treatments

all dosages, frequencies and durations prescribed

Intervention Type DRUG

Other Intervention Names

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Humira Enbrel Remicade Stelara

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Dermatology Network for Targeted Therapies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Navarini, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Swiss Society of Dermatology and Venereology (SSDV)

Julia-Tatjana Maul, PD Dr med

Role: PRINCIPAL_INVESTIGATOR

Swiss Society of Dermatology and Venereology (SSDV)

Locations

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Aarau Cantonal Hospital

Aarau, , Switzerland

Site Status RECRUITING

Basel University Hospital

Basel, , Switzerland

Site Status RECRUITING

Inselspital - Bern University Hospital

Bern, , Switzerland

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status RECRUITING

St. Gallen Cantonal Hospital

Sankt Gallen, , Switzerland

Site Status RECRUITING

Zurich University Hospital

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Marcus Streit, Dr. med.

Role: primary

062 838 68 38

Alexander Navarini, Prof.

Role: primary

Luca Borradori, Prof.

Role: primary

031 632 2111

Nikhil Yawalkar, Prof.

Role: backup

Michel Gilliet, Prof.

Role: primary

Antonio Cozzio, Prof.

Role: primary

Tatjana Maul, PD Dr.

Role: primary

Related Links

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Other Identifiers

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CNTO1275PSO4028; AG110401-IIR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IMM 10-0138; P21007224R

Identifier Type: -

Identifier Source: org_study_id