Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab

NCT ID: NCT03306446

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-17
• Study Completion Date: 2025-03-31

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.

Detailed Description

The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study will also address several questions:

• What is the rate of deep remission after a 12-month course of adalimumab in early CD patients?
• What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?
• What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.

Conditions

CD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab in monotherapy

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

Group Type: EXPERIMENTAL

Start adalimumab in monotherapy

Intervention Type: DRUG

Discontinuation of Adalimumab in patients who achieved deep remission

Interventions

Start adalimumab in monotherapy

Discontinuation of Adalimumab in patients who achieved deep remission

Intervention Type: DRUG

Other Intervention Names

begin humira in monotherapie in Early crohn disease patient

Eligibility Criteria

Inclusion Criteria

• 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
• steroid-dependent [unable to reduce corticosteroids below the equivalent of prednisolone 10 mg/d or budesonide < 6 mg/d within 3 months of starting corticosteroids without recurrent active disease, or who have a relapse within 3 months of stopping corticosteroids], 4. Patient with CDAI > 150, 5. Patient with at least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of gastrointestinal tract or colonoscopy or by video capsule conducted after failure of conventional therapy and within 12 weeks before inclusion in the study), 6. Patient naïve for anti-TNF, 7. Patient whose physician decides to start adalimumab as monotherapy independently from the study protocol, 8. Patient followed in a centre belonging to the GETAID network. 9. Written consent.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoram Bouhnik, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Laurent Peyrin-Biroulet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Locations

Chu Liege

Liège, , Belgium

Chu Amiens

Amiens, , France

Chu Besancon

Besançon, , France

CHU de Caen- Hopital de la Cote de Nacre

Caen, , France

CHU de CLERMONT FERRAND- Hopital Estain

Clermont-Ferrand, , France

APHP- Hopital BEAUJON

Clichy, , France

CHU de Colmar- Hopital Trousseau Medecine A

Colmar, , France

Chu Lille

Lille, , France

CHU de Montpellier- Hopital saint Eloi

Montpellier, , France

CHU NANTES - Hôpital Hôtel Dieu

Nantes, , France

CHU de NICE- Hopital Archet 2

Nice, , France

CHU de Nimes- Hopital Carémeau

Nîmes, , France

APHP- Hopital COCHIN

Paris, , France

APHP- Hopital BICHAT

Paris, , France

IMM

Paris, , France

CHU Bordeaux- Hopital Haut Levèque

Pessac, , France

CHU LYON- Hopital Lyon Sud

Pierre-Bénite, , France

CHU RENNES - Hopital Pontchaillou

Rennes, , France

CHU de Saint Etienne- Hopital Nord

Saint-Priest-en-Jarez, , France

CHU de TOULOUSE

Toulouse, , France

CHU de Tours - Hopital Trousseau

Tours, , France

CH Valenciennes

Valenciennes, , France

CHU NANCY - Hopital Brabois

Vandœuvre-lès-Nancy, , France

Countries

Belgium; France

Other Identifiers

GETAID 2013-1

Identifier Type: -

Identifier Source: org_study_id