NCT04191395

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Dec 2019Dec 2029

First Submitted

Initial submission to the registry

December 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

10 years

First QC Date

December 5, 2019

Last Update Submit

November 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of a second inflammatory disease

    through study completion (up to 10 years)

Study Arms (3)

Inflammatory bowel disease

Chronic inflammatory rheumatic disease

Chronic inflammatory skin diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Inflammatory Bowel Disease, Chronic Inflammatory Skin Diseases or Chronic inflammatory rheumatic disease

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn DiseaseArthritis, RheumatoidSpondylarthritisArthritis, PsoriaticPsoriasisHidradenitis Suppurativa

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone DiseasesSpondylarthropathiesSkin Diseases, PapulosquamousSkin DiseasesSkin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationHidradenitisSweat Gland Diseases

Study Officials

  • Clément Prati, Prof.

    CHU Besançon

    PRINCIPAL INVESTIGATOR
  • Lucine Vuitton, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline Vauchy, PhD

CONTACT

Stéphanie François

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 9, 2019

Study Start

December 11, 2019

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations