NCT05759104

Brief Summary

Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses). The treatment of perforating Crohn's disease is not codified.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

February 25, 2023

Last Update Submit

February 25, 2023

Conditions

Crohn Disease

Keywords

fistulaabscesspediatricsmedical treatmentsurgerydrug

Outcome Measures

Primary Outcomes (1)

  • No fistula

    Complete remission = clinical remission and biological remission and iconographic remission: * clinical remission (asymptomatic at 12 months from inclusion). * biological remission (normalization of biological parameters 12 months after inclusion). * iconographic remission (no active lesion, and in particular no visualized fistula)

    12 month

Interventions

InfliximabDRUG

Drug

Also known as: Adalimumab, Ustékinumab
StomyPROCEDURE

Surgery

Also known as: Resection

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* In consultations or hospitalized. * CHRU and CHR of Lille, Strasbourg, Colmar, Besançon, Dijon, Reims and Nancy. * Over the period from January 2012 to January 2022.

You may qualify if:

  • Minor patients (aged 3 to 18).
  • Diagnosed with Crohn's disease.
  • fistulizing crohn's disease

You may not qualify if:

  • \- perianal crohn disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseFistulaAbscess

Interventions

InfliximabAdalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSuppurationInfectionsInflammationPathologic Processes

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Humanized

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 8, 2023

Study Start

January 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2023

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share