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

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ClinicalTrials.gov Identifier: NCT03306446
Recruitment Status : Active, not recruiting
First Posted : October 11, 2017
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 17, 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

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 Name: begin humira in monotherapie in Early crohn disease patient




Primary Outcome Measures :
  1. Sustained deep remission rate [ Time Frame: 12 months ]
    Number of patients with sustained deep remission at one year


Secondary Outcome Measures :
  1. 2-year deep remission rate [ Time Frame: 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 [ Time Frame: 5 years ]
    Frequency and severity of adverse events in patients followed for 5 years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306446


Locations
Show Show 23 study locations
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
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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
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Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT03306446    
Other Study ID Numbers: GETAID 2013-1
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents