"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

Inflammatory Rhinitis Clinical Trial

— RIB18  

Official title:

"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04132258
• Other study ID #: RC18_0397
• Status: Completed
• Start date: November 19, 2019
• Est. completion date: June 19, 2020

Study information

• Verified date: June 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 19, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Inflammatory Rhinitis
• Rhinitis

Intervention

Other:
• survey
(presence of certain antecedents, weight, height, current or past existence of inflammatory rhinitis) and a second by the specialist doctor (pathology at the origin of the start of biotherapy, year of beginning of treatment, previous biotherapies over the last 3 years).

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of inflammatory rhinitis	Presence of inflammatory rhinitis yes/no	through study completion, an average of 1 year
Secondary	Characteristics associated with Patient-related characteristics in inflammatory rhinitis.	Age; Tobacco use yes/no; Diabetes yes/no; Verneuil disease yes/no; Psoriasis yes/no; Eczema in childhood yes/no; Underlying pathology (type, start year); Previous biotherapies and duration of exposure over the last 3 years yes/no	through study completion, an average of 1 year
Secondary	Characteristics of rhinitis.	Delays between the start of treatment and the onset of symptoms; Treatment under which rhinitis occurred; Rhinitis stage; Permanent or recurring, unilateral or bilateral; Associated functional signs (rhinorrhea, pain...); Quality of Life (DLQI); Presence of documented endonasal staphylococcus yes/no; Positivity of anti-nuclear antibodies yes/no; Type of treatment carried out	through study completion, an average of 1 year