CClinicalTrials.gg
Active, not recruitingNCT03306446CUREUpdated May 31, 2023

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

A Phase 4 interventional study of Start adalimumab in monotherapy in CD, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Active, not recruiting at 23 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
203
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • CD

Browse trials for

03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
203 participants (actual)

Study arms

  • 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

Interventions

  • DrugStart adalimumab in monotherapy

    Discontinuation of Adalimumab in patients who achieved deep remission

    Also known as: begin humira in monotherapie in Early crohn disease patient

05

What researchers measure

Primary outcomes

  1. Sustained deep remission rate

    Number of patients with sustained deep remission at one year

    Time frame: 12 months

Secondary outcomes

  1. 2-year deep remission rate

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

    Time frame: 2 years

Other outcomes

  1. Impact of an early treatment with adalimumab on long-term clinical outcomes

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

    Time frame: 5 years

06

Study locations

23 sites
  • Chu Liege
    Liège, Belgium
  • Chu Amiens
    Amiens, France
  • Chu Besancon
    Besançon, France
  • CHU de Caen- Hopital de la Cote de Nacre
    Caen, 14033, France
  • CHU de CLERMONT FERRAND- Hopital Estain
    Clermont-Ferrand, 67000, France
  • APHP- Hopital BEAUJON
    Clichy, 92110, France
  • CHU de Colmar- Hopital Trousseau Medecine A
    Colmar, 68024, France
  • Chu Lille
    Lille, France
  • CHU de Montpellier- Hopital saint Eloi
    Montpellier, 34295, France
  • CHU NANTES - Hôpital Hôtel Dieu
    Nantes, 44093, France
  • CHU de NICE- Hopital Archet 2
    Nice, 06200, France
  • CHU de Nimes- Hopital Carémeau
    Nîmes, 30029, France
  • APHP- Hopital COCHIN
    Paris, 75014, France
  • APHP- Hopital BICHAT
    Paris, 75018, France
  • IMM
    Paris, 75674, France
  • CHU Bordeaux- Hopital Haut Levèque
    Pessac, 33600, France
  • CHU LYON- Hopital Lyon Sud
    Pierre-Bénite, 69495, France
  • CHU RENNES - Hopital Pontchaillou
    Rennes, France
  • CHU de Saint Etienne- Hopital Nord
    Saint-Priest-en-Jarez, 42270, France
  • CHU de TOULOUSE
    Toulouse, 31403, France
  • CHU de Tours - Hopital Trousseau
    Tours, 37044, France
  • CH Valenciennes
    Valenciennes, 59322, France
  • CHU NANCY - Hopital Brabois
    Vandoeuvre Les Nancy, 54500, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03306446
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Mar 17, 2015
Primary completion
Mar 2021
Completion
Mar 2025 (estimated)
Last update
May 31, 2023

Study contacts

Yoram Bouhnik, MD
principal investigator · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Laurent Peyrin-Biroulet, MD, PhD
principal investigator · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion