Fungal infections as complication of monoclonal antibody therapy directed against IL-17 mediated inflammation: estimating incidence and severity and identifying influence of immunogenetics to establish a guideline for screening, prevention and treatment.
Recruiting
- Conditions
- fungal infectionsinflammatory skin disease100214601001752810014982
- Registration Number
- NL-OMON46165
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
* Diagnosis of psoriasis
* Age * 18 years
* Treatment with either a TNF-*-inhibitor for at least 1 year, ustekinumab for at least 1 year, secukinumab for at least 6 months, ixekizumab for at least 6 months or brodalumab for at least 6 months or planning to start treatment with an anti-Th17 mAb therapeutic agent
* Registration in the BioCAPTURE registry
Exclusion Criteria
* Pregnancy
* Any active cancer treatment
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Incidence and severity of fungal infections.<br /><br>2) Function immune system.<br /><br>3) Mycobiome/microbiome.<br /><br>4) Gene polymorphisms at DNA level.</p><br>
- Secondary Outcome Measures
Name Time Method <p>non applicable</p><br>