NCT03306446

Brief Summary

This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
203

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_4

Geographic Reach
2 countries

23 active sites

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

March 17, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

June 21, 2015

Last Update Submit

May 30, 2023

Conditions

CD

Outcome Measures

Primary Outcomes (1)

  • Sustained deep remission rate

    Number of patients with sustained deep remission at one year

    12 months

Secondary Outcomes (1)

  • 2-year deep remission rate

    2 years

Other Outcomes (1)

  • Impact of an early treatment with adalimumab on long-term clinical outcomes

    5 years

Study Arms (1)

Adalimumab in monotherapy

EXPERIMENTAL

Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.

Drug: Start adalimumab in monotherapy

Interventions

Start adalimumab in monotherapyDRUG

Discontinuation of Adalimumab in patients who achieved deep remission

Also known as: begin humira in monotherapie in Early crohn disease patient
Adalimumab in monotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient aged 18 years old to 75 years old 2. Patient with early luminal Crohn's disease (less than 24 months since diagnosis), 3. Patient who is
  • intolerant to immunosuppressants or steroids, or
  • primarily not responders to immunosuppressants for at least 3 months \[azathioprine: at least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week (subcutaneous or intramuscular route)\], and/or
  • not responder to steroids \[prednisolone equivalent at least 40 mg/d\], and/or

You may not qualify if:

  • Patient with active complex perianal fistula according to the definition of the American Gastroenterological Association (AGA) \[high anal fistula, abscess, proctitis, multiple external openings\],
  • Patient with stoma,
  • previous surgery in IBD
  • Pregnant or breastfeeding women, absence of contraception
  • Patient with any contra-indication to adalimumab.
  • Patient with any contra-indication to MRI
  • Minors and people unable to give their consent (because of their physical or mental state).
  • Subject who has not given his/her consent to participate.
  • Subject participating in another study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Chu Liege

Liège, Belgium

Location

Chu Amiens

Amiens, France

Location

Chu Besancon

Besançon, France

Location

CHU de Caen- Hopital de la Cote de Nacre

Caen, 14033, France

Location

CHU de CLERMONT FERRAND- Hopital Estain

Clermont-Ferrand, 67000, France

Location

APHP- Hopital BEAUJON

Clichy, 92110, France

Location

CHU de Colmar- Hopital Trousseau Medecine A

Colmar, 68024, France

Location

Chu Lille

Lille, France

Location

CHU de Montpellier- Hopital saint Eloi

Montpellier, 34295, France

Location

CHU NANTES - Hôpital Hôtel Dieu

Nantes, 44093, France

Location

CHU de NICE- Hopital Archet 2

Nice, 06200, France

Location

CHU de Nimes- Hopital Carémeau

Nîmes, 30029, France

Location

APHP- Hopital COCHIN

Paris, 75014, France

Location

APHP- Hopital BICHAT

Paris, 75018, France

Location

IMM

Paris, 75674, France

Location

CHU Bordeaux- Hopital Haut Levèque

Pessac, 33600, France

Location

CHU LYON- Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU RENNES - Hopital Pontchaillou

Rennes, France

Location

CHU de Saint Etienne- Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

CHU de TOULOUSE

Toulouse, 31403, France

Location

CHU de Tours - Hopital Trousseau

Tours, 37044, France

Location

CH Valenciennes

Valenciennes, 59322, France

Location

CHU NANCY - Hopital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Study Officials

  • Yoram Bouhnik, MD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

  • Laurent Peyrin-Biroulet, MD, PhD

    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2015

First Posted

October 11, 2017

Study Start

March 17, 2015

Primary Completion

March 1, 2021

Study Completion

March 1, 2025

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations

BE(1)FR(22)