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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2023
• Main ID: NCT03306446
• Date of registration: 21/06/2015
• Prospective Registration: No
• Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Public title: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab CURE
• Scientific title: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
• Date of first enrolment: March 17, 2015
• Target sample size: 203
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03306446
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, France

Contacts

• Name: Laurent Peyrin-Biroulet, MD, PhD
• Affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

• Name: Yoram Bouhnik, MD
• Affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

CD

Intervention(s)

Drug: Start adalimumab in monotherapy

Primary Outcome(s)

Sustained deep remission rate [Time Frame: 12 months]

Secondary Outcome(s)

2-year deep remission rate [Time Frame: 2 years]

Secondary ID(s)

GETAID 2013-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors