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    Summary
    EudraCT Number:2013-003199-11
    Sponsor's Protocol Code Number:2013-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-003199-11
    A.3Full title of the trial
    Changing the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CURE
    A.3.2Name or abbreviated title of the trial where available
    CURE
    A.4.1Sponsor's protocol code number2013-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGETAID
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETAID
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Lariboisière - Service Gastroentérologie 2, rue Ambroise Paré
    B.5.3.2Town/ cityParis Cedex 10
    B.5.3.3Post code75475
    B.5.3.4CountryFrance
    B.5.4Telephone number0033149952548
    B.5.5Fax number0033184109023
    B.5.6E-mailprojet@getaid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Adalimumab
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHumira
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 1-year, 2-year, 3-year, and 5-year
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    prospective cohort
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months108
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months108
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-07-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to investigator's choice (back to usual practice)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clean Web Telemedicine
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-01
    P. End of Trial
    P.End of Trial StatusOngoing
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