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

• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03306446
• Collaborator: (none)
• Enrollment: 203
• Locations: 23
• Arm: 1
• Anticipated Duration (Months): 119.5
• Patients Per Site: 8.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CD	Drug: Start adalimumab in monotherapy	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
• Actual Study Start Date: Mar 17, 2015
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Start adalimumab in monotherapy; Discontinuation of Adalimumab in patients who achieved deep remission; Other Names: begin humira in monotherapie in Early crohn disease patient

Outcome Measures

Primary Outcome Measures

1. Sustained deep remission rate [12 months]

   Number of patients with sustained deep remission at one year

Secondary Outcome Measures

1. 2-year deep remission rate [2 years]

   Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission

Other Outcome Measures

1. Impact of an early treatment with adalimumab on long-term clinical outcomes [5 years]

   Frequency and severity of adverse events in patients followed for 5 years

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Liege	Liège		Belgium
2	Chu Amiens	Amiens		France
3	Chu Besancon	Besançon		France
4	CHU de Caen- Hopital de la Cote de Nacre	Caen		France	14033
5	CHU de CLERMONT FERRAND- Hopital Estain	Clermont-Ferrand		France	67000
6	APHP- Hopital BEAUJON	Clichy		France	92110
7	CHU de Colmar- Hopital Trousseau Medecine A	Colmar		France	68024
8	Chu Lille	Lille		France
9	CHU de Montpellier- Hopital saint Eloi	Montpellier		France	34295
10	CHU NANTES - Hôpital Hôtel Dieu	Nantes		France	44093
11	CHU de NICE- Hopital Archet 2	Nice		France	06200
12	CHU de Nimes- Hopital Carémeau	Nîmes		France	30029
13	APHP- Hopital COCHIN	Paris		France	75014
14	APHP- Hopital BICHAT	Paris		France	75018
15	IMM	Paris		France	75674
16	CHU Bordeaux- Hopital Haut Levèque	Pessac		France	33600
17	CHU LYON- Hopital Lyon Sud	Pierre-Bénite		France	69495
18	CHU RENNES - Hopital Pontchaillou	Rennes		France
19	CHU de Saint Etienne- Hopital Nord	Saint-Priest-en-Jarez		France	42270
20	CHU de TOULOUSE	Toulouse		France	31403
21	CHU de Tours - Hopital Trousseau	Tours		France	37044
22	CH Valenciennes	Valenciennes		France	59322
23	CHU NANCY - Hopital Brabois	Vandoeuvre Les Nancy		France	54500

Sponsors and Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• ClinicalTrials.gov Identifier: NCT03306446
• Other Study ID Numbers: GETAID 2013-1
• First Posted: Oct 11, 2017
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Crohn Disease; Adalimumab

Study Results

No Results Posted as of Jan 20, 2021