- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191395
Evolution and Treatments of Chronic Inflammatory Systemic Diseases (MISTIC)
September 2, 2022 updated by: Centre Hospitalier Universitaire de Besancon
Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology, Dermatology and Rheumatology Departments of the University Hospital of Besançon
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charline Vauchy, PhD
- Phone Number: 0381218875
- Email: cvauchy@chu-besancon.fr
Study Locations
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-
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Besançon, France, 25000
- Recruiting
- Charline Vauchy
-
Principal Investigator:
- Clément Prati, Prof.
-
Principal Investigator:
- Lucine Vuitton, Prof.
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Principal Investigator:
- François Aubin, Prof.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Inflammatory Bowel Disease, Chronic Inflammatory Skin Diseases or Chronic inflammatory rheumatic disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Inflammatory bowel disease
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Chronic inflammatory rheumatic disease
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Chronic inflammatory skin diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnosis of a second inflammatory disease
Time Frame: through study completion (up to 10 years)
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through study completion (up to 10 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Clément Prati, Prof., CHU Besançon
- Principal Investigator: Lucine Vuitton, MD, CHU Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 11, 2019
Primary Completion (ANTICIPATED)
December 1, 2029
Study Completion (ANTICIPATED)
December 1, 2029
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
December 5, 2019
First Posted (ACTUAL)
December 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 7, 2022
Last Update Submitted That Met QC Criteria
September 2, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Arthritis
- Arthritis, Rheumatoid
- Inflammatory Bowel Diseases
- Psoriasis
- Crohn Disease
- Arthritis, Psoriatic
- Spondylitis
- Spondylarthritis
Other Study ID Numbers
- P/2019/433
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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