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    Summary
    EudraCT Number:2018-003490-10
    Sponsor's Protocol Code Number:GETAID-2018-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003490-10
    A.3Full title of the trial
    An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL trial
    A.3.2Name or abbreviated title of the trial where available
    CONTROL
    A.4.1Sponsor's protocol code numberGETAID-2018-01
    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
    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 supportAbbVie
    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 pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address50 Rue Richer
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75009
    B.5.3.4CountryFrance
    B.5.4Telephone number33685299764
    B.5.6E-mailmrahmani@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 HUMIRA
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).
    E.2.2Secondary objectives of the trial
    score >1, and a Mayo endoscopy sub score of 0 or 1)
    • Remission without steroids
    • Endoscopic healing rate with Mayo score 0 or 1
    • UCEIS score
    • Histological healing (Nancy score)
    • Remission rate and remission rate without steroids at study visits and W48
    • Quality of life evolution
    • Disability score evolution
    • Patients satisfaction
    • Continuous response
    • Safety and tolerability
    • Anti-TNF pharmacokinetics
    • Number of visits in trial
    • Number of UC related hospitalizations
    • Number of colectomies
    • Treatment compliance (questionnaire)
    • Patient adhesion (questionnaire)
    • Medico-economic analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine) or methotrexate or adults with moderately-to-severely active UC who had no response to an adequate steroid course
    - Age ≥ 18 years and < 75 years
    - Patients scheduled to start a treatment with adalimumab
    - Naïve to anti-TNF therapy and other biologics (i.e anti-integrin antibodies) or other biologics known to be effective for UC (approved or investigational)
    - Naïve to JAK inhibitors (approved or investigational)
    - moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2)
    - Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed).
    - Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication.
    - Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion.
    - A contraceptive method during the whole trial for childbearing potential female
    - Patient familiar with Smartphone and internet use
    E.4Principal exclusion criteria
    - Patients unable to give their consent (because of their physical or mental state).
    - Absence of written consent.
    - Pregnancy or breastfeeding.
    - Patients with severe acute colitis or patients at imminent risk for colectomy.
    - History of colectomy.
    - History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
    - Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.
    - Oral corticosteroids at a dose > 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion)
    - Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics, including anti-integrin antibodies (approved or investigational), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection.
    - Contraindication to anti-TNF therapy according to drug labeling:
    o Active infection.
    o Non-treated latent tuberculosis.
    o Heart failure (NYHA: Grade III and IV).
    o Malignancy during the previous 5 years.
    o Demyelinating neurological disease.
    o Current or recent (less than 4 weeks) vaccination with attenuated live vaccines
    - Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests
    - Patients using a prohibited medication
    - Patients participating in another trial or being in a follow-up period for another trial
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success of a treat to target with telemonitoring follow up using e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education compared to standard treatment follow up at W48.
    Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    E.5.2Secondary end point(s)
    - Clinical remission (Clinical remission is defined as a total Mayo score ≤2 points, with no individual sub score >1, and a Mayo endoscopy sub score of 0 or 1)
    - Remission without steroids
    - Endoscopic healing rate with Mayo score 0 or 1
    - UCEIS score
    - Histological healing (Nancy score)
    - Remission rate and remission rate without steroids at study visits and W48
    - Quality of life evolution (evaluate visit 0 vs W14, W26, W38 and W48)
    - Patients satisfaction
    - Continuous response
    - Safety and tolerability
    - Anti-TNF pharmacokinetics
    - Number of visits in trial
    - Number of UC related hospitalizations
    - Number of colectomies
    - Treatment compliance (questionnaire)
    - Patient adhesion (questionnaire)
    - Medico-economic analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Therapeutic strategy: Comparing standard of care VS treat to target with telemonitoring
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States No
    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 years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    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: 238
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 238
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state238
    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)
    None
    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 SBIM
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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