Swiss Dermatology Network of Targeted Therapies (SDNTT)

NCT01706692 | Recruiting

• 2 other identifiers: IMM 10-0138; P21007224RCNTO1275PSO4028; AG110401-IIR
• Study Type: observational
• Target: 1,121
• Locations: 1 country
• Sites: 6

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 10 years, regardless of subsequent therapy. The registry will also evaluate safety clinical outcomes and health related quality of life.

Conditions

Psoriasis

Keywords

Methotrexate; Acitretin; Cyclosporine A; Systemic PUVA; Infliximab; Adalimumab; Etanercept; Ustekinumab; Fumaric acids; Psoriasis; Psoriatic arthritis; Skin disease

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area Severity Index (PASI)

  To evaluate clinical outcome of patients exposed to conventional systemic or biologic therapy for psoriasis/psoriatic-arthritis

  every 6 months for 10 years

Secondary Outcomes (1)

• Dermatology Life Quality Index (DLQI)

  every 6 months for 10 years

Other Outcomes (1)

• Adverse and serious adverse events

  10 years

Study Arms (8)

Adalimumab

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

Biological: Adalimumab

Etanercept

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

Biological: Etanercept

Infliximab

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

Biological: Infliximab

Ustekinumab

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

Biological: Ustekinumab

Cyclosporine A

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

Drug: Cyclosporine A

Fumaric acids

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

Drug: Fumaric acids

Methotrexate

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

Drug: Methotrexate

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

Interventions

Adalimumab BIOLOGICAL

all dosages, frequencies and durations prescribed

Also known as: Humira

Adalimumab

Etanercept BIOLOGICAL

all dosages, frequencies and durations prescribed

Also known as: Enbrel

Etanercept

Infliximab BIOLOGICAL

all dosages, frequencies and durations prescribed

Also known as: Remicade

Infliximab

Ustekinumab BIOLOGICAL

all dosages, frequencies and durations prescribed

Also known as: Stelara

Ustekinumab

Cyclosporine A DRUG

all dosages, frequencies and durations prescribed

Cyclosporine A

Fumaric acids DRUG

all dosages, frequencies and durations prescribed

Fumaric acids

Methotrexate DRUG

all dosages, frequencies and durations prescribed

Methotrexate

Other anti-psoriatic systemic treatments DRUG

all dosages, frequencies and durations prescribed

Other anti-psoriatic systemic treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Dermatology Network for Targeted Therapies: lead

Study Sites (6)

Aarau Cantonal Hospital

Aarau, CH-5001, Switzerland

RECRUITING

Basel University Hospital

Basel, CH-4031, Switzerland

RECRUITING

Inselspital - Bern University Hospital

Bern, CH-3001, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, CH-1011, Switzerland

RECRUITING

St. Gallen Cantonal Hospital

Sankt Gallen, CH-9007, Switzerland

RECRUITING

Zurich University Hospital

Zurich, CH-8091, Switzerland

RECRUITING

Related Links

• SDNTT
• German registry PsoBest

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic; Skin Diseases

Interventions

Adalimumab; Etanercept; Infliximab; Ustekinumab; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexander Navarini, Prof Dr med

  Swiss Society of Dermatology and Venereology (SSDV)

  PRINCIPAL INVESTIGATOR

• Julia-Tatjana Maul, PD Dr med

  Swiss Society of Dermatology and Venereology (SSDV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 15, 2012
• Study Start: February 1, 2011
• Primary Completion (Estimated): March 15, 2032
• Study Completion (Estimated): March 15, 2032
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

CH (6)