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CompletedNCT04132258RIB18Updated Jun 8, 2021

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

An observational study in Inflammatory Rhinitis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
356
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Inflammatory Rhinitis

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03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 356 is above the median of 141 across 172 observational studies indexed under Rhinitis.

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Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Translated with www.DeepL.com/Translator

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

Exclusion Criteria:

  • Patient under legal protection measure,
  • Refusal of the subject to participate in the study,
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
356 participants (actual)
Patient registry
No

Interventions

  • Othersurvey

    (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).

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What researchers measure

Primary outcomes

  1. Prevalence of inflammatory rhinitis

    Presence of inflammatory rhinitis yes/no

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

  2. 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

    Time frame: through study completion, an average of 1 year

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Study locations

1 site
  • University Hospital
    Nantes, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04132258
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Oct 18, 2019
Start date
Nov 19, 2019
Primary completion
Jun 19, 2020
Completion
Jun 19, 2020
Last update
Jun 8, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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