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Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Sponsor: Clin4all
Summary
Psoriasis is a chronic inflammatory disease that affects 125 million people around the world with major repercussions on physical and emotional quality of life of patients. Many studies confirmed the association between psoriasis and comorbidities as cardio vascular diseases, gastroinstestinal, kidney diseases, cancers, infections or mood disorders. Psoriasis, specially, when it is severe, is associated with highest mortality and a disease burden linked to comorbidities. Understanding this disease burden associated to psoriasis is crucial for an optimal medical care. Tildrakizumab is indicated in treatment of moderate-to-severe plaque psoriasis in adults who need a systemic treatment, also, in case of failure, intolerance or contraindication to a systemic treatment, including Methotrexate. The aim of TILFLEX study is to evaluate the efficacy, safety and flexibility of Tildrakizumab in patients with moderate-to-severe plaque psoriasis with disease burden and/or body weight \> 90Kg. The main objective is to evaluate the efficacy of Tildrakizumab 200mg at week (W)28.
Official title: Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden - TILFLEX Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-02-18
Completion Date
2027-04
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Psoriasis clinical assessment
Global evaluation of psoriasis and specific evaluation by areas if applicable
Assessment of comorbidities
Medical history of patient and assessment of comorbidities at each visit
Quality of life evaluation
DLQI questionnaire at each visit
Well-being evaluation
Evaluation by questionnaire WHO-5 (french version) at each visit
Treatment compliance
Assessment by a self-adminitreted questionnaire at W28, W52, W76
Physical activity assessment
Self-administreted questionnaire at W0 and W76
Locations (1)
Service de Dermatologie - CHU Toulouse-Hôpital Larrey
Toulouse, France