Clinical trial NCT04132258: "Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"
Official title: "Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Rhinitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of patients on biotherapies that meet the inclusion criteria as exhaustively as possible.

* Major patients, followed at the University Hospital of Angers and Nantes, in the dermatology, gastroenterology and rheumatology departments for chronic inflammatory diseases requiring treatment with biotherapy started at least 3 months ago.
* Recruitment during consultations in the specialties concerned or in the day hospitals planned for the administration of treatments.

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Brief summary: Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Detailed description: Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. It can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by Cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. Some authors also describe associated paradoxical psoriasiform reactions or an impetigo. In our experience, this condition is more frequently found in patients treated for IBD or SPA and has a clinically characteristic fissure appearance. Thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described.

The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Patient recruitment will take place over a one-year period, in a multi-centre manner (Angers and Nantes University Hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patient (\> 18 years of age),
* Biotherapy treatment: anti TNF, ustekinumab, secukinumab, ixekizumab, Rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti Il1, Anti Il6,
* Biotherapy treatment \> 3 months,
* Chronic inflammatory disease: psoriasis, ankylosing spondylitis (SPA), rheumatoid arthritis (RA), Crohn's disease (CD), bleeding rectocolitis (HRC)
* No opposition to the study

Exclusion Criteria:

* Patient under legal protection measure,
* Refusal of the subject to participate in the study,

Primary outcomes:
measure: Prevalence of inflammatory rhinitis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Characteristics associated with Patient-related characteristics in inflammatory rhinitis.
timeFrame: through study completion, an average of 1 year
measure: Characteristics of rhinitis.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References: