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Enrolling by invitation NCT03254667

LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis

Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brodalumab, Comparator Drug (non-biologic IL-17 inhibitors).
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective, Observational Study Brodalumab Compared With Other Therapies in the Treatment of Adults With Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Overview

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis

Detailed description

Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Interventions

  • Biological Brodalumab
    Brodalumab
  • Drug Comparator Drug (non-biologic IL-17 inhibitors)
    Comparator subjects treated with non-biologic IL-17 inhibitors

Primary outcome measures

  • Assess the incidence of malignancy [Time frame: 8 years]

Eligibility criteria

Inclusion criteria

  • Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist
  • Must be at least 18 years of age or older
  • Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted.

Exclusion criteria

  • The subject is unable or unwilling to provide informed consent to participate in the registry.
  • The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial).
  • The subject is restarting the eligible medication less than 12 months since receiving the last dose.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Registry — Bridgewater

Identifiers

NCT: NCT03254667 · V01-BROA-402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗