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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

Tracking Information
First Submitted Date  ICMJE June 21, 2015
First Posted Date  ICMJE October 11, 2017
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE March 17, 2015
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
Sustained deep remission rate [ Time Frame: 12 months ]
Number of patients with sustained deep remission at one year
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
Official Title  ICMJE Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CD
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Start adalimumab in monotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
203
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2017)
200
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306446
Other Study ID Numbers  ICMJE GETAID 2013-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Sponsor  ICMJE Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP