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    Summary
    EudraCT Number:2018-001382-17
    Sponsor's Protocol Code Number:RP1610
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001382-17
    A.3Full title of the trial
    Stopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and effectiveness of continuing existing 5-ASA medication versus stopping it.
    A.3.2Name or abbreviated title of the trial where available
    STATIC
    A.4.1Sponsor's protocol code numberRP1610
    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 SponsorAlimentiv Inc
    B.1.3.4CountryCanada
    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 supportAcademic Medical Organization of Southwestern Ontario
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportWestern University - Department of Medicine
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlimentiv
    B.5.2Functional name of contact pointLee Anne Williamson
    B.5.3 Address:
    B.5.3.1Street Address100 Dundas St, Suite 200
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeN6A5B6
    B.5.3.4CountryCanada
    B.5.4Telephone number+12262707674
    B.5.6E-mailLeeAnne.Williamson@alimentiv.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.4EV Substance CodeSUB08782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.4 to 4.8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Inactive Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Inactive Crohn’s Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 determine whether withdrawal of aminosalicylates is non-inferior to the continuation of aminosalicylate therapy in participants with Crohn's Disease (CD) in remission with regard to a primary endpoint of any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within 24 months after treatment allocation.
    E.2.2Secondary objectives of the trial
    Any CD-related complication (composite of either a CD-related or CD treatment-related surgery or hospitalization) within first 12 months.
    Each individual component of the primary composite endpoint within 12 and 24 months.
    The use of systemic corticosteroids for treatment of CD flares within 12 and 24 months.
    Time to first CD-related complication (either CD-related or CD treatment-related surgery, hospitalization, or other) and each component individually.
    Change in disease activity from baseline to 6, 12, and 24 months.
    Change in quality of life from baseline to 6, 12, and 24 months.
    Change in C-reactive protein concentration from baseline to 6, 12, and 24 months.
    Change in faecal calprotectin level from baseline to 12 and 24 months.
    Estimated CD-related drug treatment costs over the 24 months after enrollment compared to the 12 months prior.
    Estimated CD-related and total healthcare costs over the 24 months after enrollment compared to the 12 months prior.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 years or older in primary or secondary care.
    2. Documented diagnosis of CD previously confirmed by endoscopy and histology at least 3 months prior to enrollment.
    3. Taking any brand or dosage of an oral aminosalicylate for at least 6 months prior to enrollment.
    4. Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses).
    5. CD currently in clinical remission, defined as:
    a. An HBI score ≤ 4 at enrollment visit AND
    b. No escalation in medication for the treatment of a CD flare within 3 months prior to enrollment AND
    c. No use of systemic corticosteroids for CD (2 continuous weeks or more) within the 3 months prior to enrollment AND
    d. Clinician judgement of disease remission.
    6. Able to participate fully in all aspects of the clinical trial.
    7. Written informed consent obtained and documented.
    E.4Principal exclusion criteria
    1. A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis.
    2. A diagnosis of short-bowel syndrome.
    3. Active perianal disease (note: a history of perianal disease is permitted).
    4. Active fistulizing disease (note: a history of fistulizing disease is permitted).
    5. A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery.
    6. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment.
    7. Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment.
    8. Unwillingness to stop taking aminosalicylates for the duration of the trial.
    9. Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment.
    10. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participants ability to participate fully in the study.
    11. History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome, any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization,
    or other complication) will be assessed over 24 months.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 Months
    E.5.2Secondary end point(s)
    The secondary outcome evaluations of this study are to compare the effect of withdrawal of aminosalicylates to the continuation of aminosalicylate therapy with regards to:
    1. Any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within the first 12 months after enrollment.
    2. Each individual component of the primary composite endpoint (CD-related or CD-treatment related surgeries, hospitalizations and other complications) within 12 and 24 months after enrollment.
    3. The use of systemic corticosteroids for treatment of CD flares within 12 and 24 months after Enrollment.
    4. Time to first CD-related complication (either CD-related or CD treatment-related surgery, hospitalization, or other complication) and each component of the composite individually.
    5. Change in disease activity from baseline to 6, 12, and 24 months after enrollment, as assessed by changes in the HBI.
    6. Change in the quality of life instrument, the CUCQ-32 (Appendix 14.2), from baseline to 6, 12, and 24 months after enrollment.
    7. Change in CRP concentration from baseline to 6, 12, and 24 months after enrollment.
    8. Change in fecal calprotectin level from baseline to 12 and 24 months after enrollment.
    9. Estimated CD-related drug treatment costs over the 24 months after enrollment compared to the 12 months prior to enrollment.
    10. Estimated CD-related and total healthcare costs over the 24 months after enrollment compared to the 12 months prior to enrollment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, and 24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    treatment and healthcare costs
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United Kingdom
    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
    Last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 1580
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-10
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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