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

CD Clinical Trial

— CURE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03306446
• Other study ID #: GETAID 2013-1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 17, 2015
• Est. completion date: March 2025

Study information

• Verified date: May 2023
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: March 2025
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• CD
• Crohn Disease

Intervention

Drug:
• Start adalimumab in monotherapy
Discontinuation of Adalimumab in patients who achieved deep remission

Locations

Country	Name	City	State
Belgium	Chu Liege	Liège
France	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 BICHAT	Paris
France	APHP- Hopital COCHIN	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	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of an early treatment with adalimumab on long-term clinical outcomes	Frequency and severity of adverse events in patients followed for 5 years	5 years
Primary	Sustained deep remission rate	Number of patients with sustained deep remission at one year	12 months
Secondary	2-year deep remission rate	Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission	2 years