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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04191395
Other study ID # P/2019/433
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 11, 2019
Est. completion date December 2029

Study information

Verified date September 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Charline Vauchy, PhD
Phone 0381218875
Email cvauchy@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with chronic inflammatory diseases (CID) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease [MC] and ulcerative colitis [RCH]), chronic inflammatory skin diseases (psoriasis or Verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis [RA] and spondyloarthritis [SpA] including psoriatic arthritis [PsA]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 2029
Est. primary completion date December 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients treated for IBD (MC, UC or indeterminate colitis) in the gastroenterology department of Besançon University Hospital - Subject meeting the clinical, morphological and histological diagnostic criteria for MC, UC or indeterminate colitis or - Patients treated for chronic inflammatory rheumatism (RA, SpA, PsA) in the rheumatology department of the University Hospital of Besançon Subject meeting the ACR 2010 classification criteria of RA or modified New York criteria of Ankylosing spondylitis or ASAS criteria of axial or peripheral SpA or CASPAR criteria of PsA or - Patients treated for chronic inflammatory skin disease (Psoriasis, Verneuil's disease) in the dermatology department of the University Hospital of Besançon Exclusion Criteria: - Opposition of the patient - Patients in emergency situation, persons deprived of their liberty, protected minors or adults.

Study Design


Locations

Country Name City State
France Charline Vauchy Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of a second inflammatory disease through study completion (up to 10 years)
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