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

Primary Purpose

CD

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Start adalimumab in monotherapy
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Liege
  • Chu Amiens
  • Chu Besancon
  • CHU de Caen- Hopital de la Cote de Nacre
  • CHU de CLERMONT FERRAND- Hopital Estain
  • APHP- Hopital BEAUJON
  • CHU de Colmar- Hopital Trousseau Medecine A
  • Chu Lille
  • CHU de Montpellier- Hopital saint Eloi
  • CHU NANTES - Hôpital Hôtel Dieu
  • CHU de NICE- Hopital Archet 2
  • CHU de Nimes- Hopital Carémeau
  • APHP- Hopital COCHIN
  • APHP- Hopital BICHAT
  • IMM
  • CHU Bordeaux- Hopital Haut Levèque
  • CHU LYON- Hopital Lyon Sud
  • CHU RENNES - Hopital Pontchaillou
  • CHU de Saint Etienne- Hopital Nord
  • CHU de TOULOUSE
  • CHU de Tours - Hopital Trousseau
  • CH Valenciennes
  • CHU NANCY - Hopital Brabois

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab in monotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Sustained deep remission rate
Number of patients with sustained deep remission at one year

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2015
Last Updated
May 30, 2023
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT03306446
Brief Title
Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
Acronym
CURE
Official Title
Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2015 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab in monotherapy
Arm Type
Experimental
Arm Description
Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
Intervention Type
Drug
Intervention Name(s)
Start adalimumab in monotherapy
Other Intervention Name(s)
begin humira in monotherapie in Early crohn disease patient
Intervention Description
Discontinuation of Adalimumab in patients who achieved deep remission
Primary Outcome Measure Information:
Title
Sustained deep remission rate
Description
Number of patients with sustained deep remission at one year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
2-year deep remission rate
Description
Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Impact of an early treatment with adalimumab on long-term clinical outcomes
Description
Frequency and severity of adverse events in patients followed for 5 years
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Bouhnik, MD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent Peyrin-Biroulet, MD, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Liege
City
Liège
Country
Belgium
Facility Name
Chu Amiens
City
Amiens
Country
France
Facility Name
Chu Besancon
City
Besançon
Country
France
Facility Name
CHU de Caen- Hopital de la Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU de CLERMONT FERRAND- Hopital Estain
City
Clermont-Ferrand
ZIP/Postal Code
67000
Country
France
Facility Name
APHP- Hopital BEAUJON
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Colmar- Hopital Trousseau Medecine A
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Chu Lille
City
Lille
Country
France
Facility Name
CHU de Montpellier- Hopital saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU NANTES - Hôpital Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de NICE- Hopital Archet 2
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
CHU de Nimes- Hopital Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
APHP- Hopital COCHIN
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
APHP- Hopital BICHAT
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
IMM
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHU Bordeaux- Hopital Haut Levèque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CHU LYON- Hopital Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU RENNES - Hopital Pontchaillou
City
Rennes
Country
France
Facility Name
CHU de Saint Etienne- Hopital Nord
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHU de TOULOUSE
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
CHU de Tours - Hopital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
CHU NANCY - Hopital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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