Clinical trial

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

Name
V01-BROA-402
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
Trial arms
Trial start
2017-07-25
Estimated PCD
2030-11-10
Trial end
2031-11-01
Treatment
Brodalumab
Brodalumab
Arms:
Brodalumad exposed
Comparator Drug (non-biologic IL-17 inhibitors)
Comparator subjects treated with non-biologic IL-17 inhibitors
Arms:
Comparator Subjects
Size
3500
Primary endpoint
Assess the incidence of malignancy
8 years
Eligibility criteria
Inclusion Criteria: 1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist 2. Must be at least 18 years of age or older 3. 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: 1. The subject is unable or unwilling to provide informed consent to participate in the registry. 2. 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). 3. The subject is restarting the eligible medication less than 12 months since receiving the last dose.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '8 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Neutrophil count'}, 'enrollmentInfo': {'count': 3500, 'type': 'ESTIMATED'}}
Updated at
2024-02-23

1 organization

2 products

1 indication

Product
Brodalumab
Indication
Psoriasis