MISTIC: Evolution and Treatments of Chronic Inflammatory Systemic Diseases

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04191395

Collaborator

(none)

3,000

Enrollment

Location

119.7

Anticipated Duration (Months)

25.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with chronic inflammatory diseases (CID) followed in gastroenterology 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]), 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Arthritis, Rheumatoid Spondyloarthritis Psoriatic Arthritis

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology and Rheumatology Departments of the University Hospital of Besançon

Actual Study Start Date :

Dec 11, 2019

Anticipated Primary Completion Date :

Dec 1, 2029

Anticipated Study Completion Date :

Dec 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Inflammatory bowel disease
Chronic inflammatory rheumatic disease

Outcome Measures

Primary Outcome Measures

Diagnosis of a second inflammatory disease [through study completion (up to 10 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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