Brief Summary

The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach

1 country

9 active sites

Status

completed

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

2.2 years study duration

First Submitted

Initial submission to the registry

September 11, 2015

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

2.2 years

First QC Date

September 11, 2015

Last Update Submit

July 30, 2018

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseDigestive DamageLemann Index

Outcome Measures

Primary Outcomes (1)

Digestive damage
Evaluate digestive damage in Crohn's Disease by using Lemann Index
5 to 10 years after diagnosis

Secondary Outcomes (3)

Predictive factors of the digestive damage evolution
5 to 10 years after diagnosis
Predictive factors of the digestive damage evolution
5 to 10 years after diagnosis
Variation of Lemann Index
5 to 10 years after diagnosis

Study Arms (1)

Evaluation group

EXPERIMENTAL

Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations. All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations : * Upper tract location : upper endoscopy * Colorectal location : colonoscopy * Perianal location : pelvic MRI * All patients : abdominal MRI

Procedure: Abdominal MRIProcedure: Upper endoscopyProcedure: ColonoscopyProcedure: Pelvic MRI

Interventions

Abdominal MRIPROCEDURE

Abdominal MRI to realize within 4 months following inclusion

Evaluation group

Upper endoscopyPROCEDURE

Upper endoscopy to realize within 4 months following inclusion

Evaluation group

ColonoscopyPROCEDURE

Colonoscopy to realize within 4 months following inclusion

Evaluation group

Pelvic MRIPROCEDURE

Pelvic MRI to realize within 4 months following inclusion

Evaluation group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients over 18 years old
Active or Inactive Crohn's Disease
Previously enrolled in RAPID clinical trial

You may not qualify if:

Pregnant or nursing woman
Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestiveslead

Study Sites (9)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

CHRU Lille

Lille, France

Location

CHU NICE

Nice, 06202, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

IMM

Paris, 75014, France

Location

CHU Bordeaux - Pessac

Pessac, 33700, France

Location

Chu Toulouse

Toulouse, 31403, France

Location

Related Publications (2)

Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panes J, Scholmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lemann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.
PMID: 25241327BACKGROUND
Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.
PMID: 23644079BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

GastroscopyColonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

Benjamin Pariente, MD, PhD
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
PRINCIPAL INVESTIGATOR
Jacques Cosnes, MD
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

December 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

FR(9)

Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Evaluation group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Evaluation group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations