CURE

• Register: EUCTR
• Last refreshed on: 28 May 2018
• Main ID: EUCTR2013-003199-11-BE
• Date of registration: 27/07/2015
• Prospective Registration: Yes
• Primary sponsor: GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives
• Public title: CURE
• Scientific title: Changing the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE
• Date of first enrolment: 25/09/2015
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003199-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: prospective cohort; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, France

Contacts

• Name: Clinical Project Manager
• Affiliation: GETAID

• Name: Clinical Project Manager
• Affiliation: GETAID

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patient aged 18 to 75
2. Patient with early luminal Crohn's disease (less than 24 months since diagnosis),
3. Patient
- 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 conducted after failure of conventional therapy and within 12 weeks before inclusion in the study or capsule endoscopy ),
6. Patient naïve for all biologics known to be effective for Crohn's Disease
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 surgical history for Crohn Disease
- 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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's disease

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Intervention(s)

Trade Name: Adalimumab
Product Name: Humira
Pharmaceutical Form: Injection

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate the sustained deep remission rate one year after discontinuation of a 12-month course of adalimumab in adult patients with early Crohn's disease (CD) who 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

Primary end point(s): The primary study endpoint will be the percentage of patients with sustained deep remission 12 months after a 12-month course of adalimumab in patients who achieved deep remission without therapeutic intervention (i.e. no surgery, no clinical flare-up, no introduction of CD-related treatment, no need for adalimumab optimization) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250µg/g) at 6 months.

Secondary Objective: The secondary objectives of this study are:
- To assess predictors of loss of deep remission during the year following treatment withdrawal in patients who achieved remission, after 1 year adalimumab course.
- To estimate the 2-year deep remission rate in patients who did not achieve 1-year deep remission,
- To assess efficacy and tolerability of a 12-month adalimumab course,
- To assess efficacy and tolerability of a 12-month retreatment with adalimumab following CD reactivation.
- To assess the impact of an early treatment with adalimumab on longterm clinical outcomes (bowel damage, CD-related surgeries, hospitalizations, patient's reported outcomes such as fatigue, disability and quality of life) by following all patients for 5 years after study inclusion.

Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome(s)

Secondary end point(s): • In patients with deep remission after the 12-month course of adalimumab, identification of predictors of loss of deep remission during the following year,
• Deep remission rate after a 12-month course of adalimumab and identification of predictors,
• Deep remission rate after a 24-month course of adalimumab in patients who did not experience deep remission after a 12-month course of adalimumab,
• Deep remission rate after a 36-month course of adalimumab in patients who were not in deep remission after a 24-month course of adalimumab,
• Time to first clinical relapse after adalimumab discontinuation,
• Changes in CDAI over the study,
• Changes in CRP and fecal calprotectin over the study,
• Change from baseline in CDEIS score at 12-month and 5-year,
• Proportion of patients with at least one colonic ulcer at 1-year, 2-year, 3-year and 5-year evaluations,
• Time to first surgery,
• Time to first CD-related hospitalization,
• Total duration of CD-related hospital stays over the 5-year study,
• Change from baseline in fatigue at 1-year, 2-year, 3-year and 5-year evaluations,
• Change from baseline in quality of life at 1-year, 2-year, 3-year and 5- year evaluations,
• Change from baseline in Disability Inflammatory Bowel Disease index at 1-year, 2-year, 3-year, 4-year and 5-year evaluations,
• Bowel wall damage (stenosis, fistula, abscess) at GI-IRM at 1-year, 2- year, 3-year and 5-year evaluations,
• Safety and tolerability of treatment and retreatment with adalimumab.

Timepoint(s) of evaluation of this end point: at 1-year, 2-year, 3-year, and 5-year

Secondary ID(s)

2013-1

Source(s) of Monetary Support

GETAID