Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChronicle Academy
About this trial
This is a multi-centre, non-interventional, open-label, prospective observational study that will be conducted across Canada over 52-week duration. Approximately 80 patients who are initiating tildrakizumab as part of their routine care through the ILUMYA SUPPORT® Program and meet the study's eligibility criteria will be enrolled. Specifically, the study will enroll patients with Fitzpatrick scale skin types III and above.
The real-world impact, safety and effectiveness of tildrakizumab on patients with moderate-to-severe plaque psoriasis (PsO) remain largely undocumented in Canada, despite its approval in 2018. Given Canada's diverse population, this study presents an opportunity to evaluate tildrakizumab's quality of life, safety and effectiveness in specific demographic groups, particularly those patients with Fitzpatrick scale skin type III and above.
The findings from this study will help optimize care, address unmet needs, and ensure that treatment outcomes are inclusive and reflective of Canada's diverse population.
Eligibility criteria
Qualifiers
Adults aged 18 years or older.
Diagnosis of moderate-to-severe chronic plaque-type PsO with Fitzpatrick scale type III or above (BSA >/=3%).
Candidate for phototherapy and/or systemic therapy.
Planning to initiate tildrakizumab as part of routine clinical care through the ILUMYA SUPPORT® Program for the treatment of plaque PsO but has not yet received their first dose.
Disqualifiers
Known hypersensitivity to tildrakizumab, its excipients, or components of the container, as outlined in the Product Monograph.
Concurrently taking any oral medication for treatment of PsO (e.g. methotrexate, cyclosporin, acitretin)
Diagnosis of only palmoplantar psoriasis
Concurrent medical condition or significant comorbidities that, in the investigator's opinion, would prevent participation in the study or interfere with study assessments
Trial design
Treatments tested in this trial
- Not listed
Trial groups
80 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov