Evolution and Treatments of Chronic Inflammatory Systemic Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

  • - Opposition of the patient.
  • - Patients in emergency situation, persons deprived of their liberty, protected minors or adults.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04191395
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Besancon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clément Prati, Prof.Lucine Vuitton, MD
Principal Investigator Affiliation CHU BesançonCHU Besançon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, Arthritis, Rheumatoid, Spondyloarthritis, Psoriatic Arthritis
Arms & Interventions

Arms

: Inflammatory bowel disease

: Chronic inflammatory rheumatic disease

Interventions

Contact a Trial Team

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International Sites

Charline Vauchy, Besançon, France

Status

Recruiting

Address

Charline Vauchy

Besançon, , 25000

Site Contact

Charline Vauchy, PhD

[email protected]

0381218875

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