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    Summary
    EudraCT Number:2015-005260-41
    Sponsor's Protocol Code Number:SA652012
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-005260-41
    A.3Full title of the trial
    Efficacy of optimized thiopurine therapy in ulcerative colitis.
    Effectiviteit van geoptimaliseerde thiopurine therapie in colitis ulcerosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of optimized thiopurine therapy in ulcerative colitis.
    Effectiviteit van geoptimaliseerde thiopurine therapie in colitis ulcerosa.
    A.3.2Name or abbreviated title of the trial where available
    OPTIC
    A.4.1Sponsor's protocol code numberSA652012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02910245
    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 SponsorAcademic Medical Centre
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Centre
    B.5.2Functional name of contact pointMark Löwenberg
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.lowenberg@amc.uva.nl
    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 Mercaptopurine (Puri-Nethol)
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.11 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 Yes
    D.3.11.13.1Other medicinal product type Purine analoge
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colitis Ulcerosa
    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 19.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 the proposed this study is to evaluate the efficacy of optimized thiopurine therapy. Therapeutic drug monitoring (TDM) will be applied in order to optimize treatment outcomes and objective endoscopic endpoints will be used. Optimized use of thiopurines may lead to prolonged and better disease outcome and avoidance of costly biological therapy or surgery.
    Het primaire doel van deze studie is om het effect van geoptimaliseerde thiopurine therapie te onderzoeken. Therapeutic Drug Monitoring (TDM) zal worden toegepast om de behandeluitkomsten te optimaliseren en objectieve endoscopische eindpunten zullen worden gebruikt. Optimalisatie van de behandeling met thiopurines zou kunnen leiden tot een langere en betere ziekte-uitkomst en het voorkomen van dure therapie met anti-TNF antilichamen of chirurgie.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to conduct a cost-utility and budget impact analysis of optimized thiopurine therapy and to identify biomarkers as potential predictors of thiopurine response in mucosal biopsies, feces and blood.
    Secundaire doelen zijn om een kostenutiliteitsanalyse en budget impact analyse te doen en om biomarkers te identificeren als potentiële voorspellers voor thiopurine respons in mucosale biopsies, feces en bloed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmed diagnosis of UC by endoscopy and histopathology
    2. Patients between 18 and 80 years of age
    3. Active disease, despite oral treatment with at least 2g/day 5-ASA
    4. Treatment with oral corticosteroids is required
    1. CU is gediagnosticeerd door middel van endoscopie en histopathologie
    2. Patiënten tussen de 18 en 80 jaar oud
    3. Actieve ziekte, ondanks orale behandeling met minstens 2 gram 5-ASA per dag
    4. Behandeling met orale corticosteroïden is noodzakelijk
    E.4Principal exclusion criteria
    1. Prior treatment with thiopurines
    2. Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
    3. Current pregnancy (a pregnancy test will be performed if necessary according to the treating physician.)
    4. Chronic Obstructive Pulmonary Disease (COPD)
    5. Acute coronary heart disease
    6. (Bacterial) gastroenteritis has to be treated first
    7. Coagulation disorders
    8. Active malignancy
    9. History of colonic dysplasia/cancer
    10. Extensive colonic resection, i.e. subtotal colectomy with less than 15 cm colon in situ
    11. Concomitant therapy with drugs interfering with MP metabolism, like allopurinol, ribavirin or anti-epileptics.
    12. Known systemic fungal infections or parasitic infections have to be treated first
    13. Known duodenal or ventricular ulcus
    14. Substance abuse, such as alcohol (at least 80 gram/day – one standard glass contains 10 gram of alcohol), I.V. drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded
    15. Positive tuberculosis screen (when a screening is performed at the discretion of the treating physician)
    16. Active hepatitis B virus or hepatitis C virus infection defined as a positive anti-HCV, HBsAg and/or anti-HBcore screening.
    17. Leucopenia (Neutrophil count below 1,8x10^9/L)
    18. Thrombopenia (Platelets below 90x10^9/L)
    19. Elevated liver enzymes (over 2x ULN)
    20. Abnormal renal function (eGFR below 30 mL/min)
    21. Other conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedure
    1. Eerder behandeling met thiopurines gehad
    2. Eerdere behandeling met biologics (e.g. anti-TNF agents en vedolizumab)
    3. Zwangerschap (een zwangerschapstest zal worden uitgevoerd indien dit noodzakelijk wordt geacht door de behandelend arts)
    4. Chronische Obstructieve Longziekte (COPD)
    5. Acute coronaire hartziekten
    6. (Bacterial) gastroenteritis moet behandeld worden alvorens inclusie is toegestaan
    7. Stollingsstoornis
    8. Actieve maligniteit
    9. Geschiedenis van colondysplasie/carcinoom
    10. Uitgebreide resectie van het colon, i.e. subtotale colectomie met minder dan 15 cm colon in situ
    11. Gelijktijdige behandeling met medicatie die interfereren met het MP metabolisme, zoals allopurinol, ribavirine of anti-epileptica.
    12. Bekende systemische parasitaire of schimmelinfecties moeten eerst behandeld worden.
    13. Bekend ulcus duodeni of ventriculi
    14. Middelenmisbruik, zoals alcohol (minstens 80 gram/dag - een standaard glas bevat 10 gram alcohol), I.V. drugs en drugs die geïnhaleerd worden. Indien de proefpersoon een geschiedenis van middelenmisbruik heeft en er toch wordt overwogen de persoon te includeren, moet de proefpersoon minstens 2 jaar abstinent zijn. Proefpersonen die methadon gebruiken of hebben gebruikt binnen de afgelopen twee jaren worden geëxcludeerd
    15. Positieve tuberculose screening (indien een screening is uitgevoerd omdat dit noodzakelijk was volgens de behandelend arts)
    16. Actieve hepatitis B virus or hepatitis C virus infectie gedefinieerd als een positieve anti-HCV, HBsAg en/of anti-HBcore screening.
    17. Leukopenie (aantal neutrofiele granulocyten minder dan 1,8x10^9/L)
    18. Trombocytopenie (aantal trombocyten lager dan 90x10^9/L)
    19. Verhoogde leverenzymen (minstens 2x ULN)
    20. Verminderde nierfunctie (eGFR lager dan 30 mL/min)
    21. Andere aandoeningen of condities die volgens de onderzoeker kunnen interfereren met het vermogen van de proefpersoon om alle studieprocedures zonder problemen te doorlopen.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint of this study is clinical and endoscopic remission, which we defined as a SCCAI-score of maximum 4, a UCEIS-score of maximum 3 and a total Mayo-score of maximum 2, with no individual subscore above 1.
    Het primaire eindpunt van deze studie is klinische en endoscopische remissie, gedefinieerd als een SCCAI-score van maximaal 4, een UCEIS-score van maximaal 3 en een totale Mayo-score van maximaal 2, waarvan geen individuele subscore hoger is dan 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year after start of the treatment (week 52)
    Een jaar na start van de behandeling (week 52)
    E.5.2Secondary end point(s)
    - Occurrence of (serious) adverse events ((S)AE)
    - Leukocyte counts
    - Liver function tests
    - Occurrence of subjective thiopurine intolerance
    - 6-TGN levels
    - 6-MMP levels
    - Occurrence of treatment failure
    - Occurrence of flares and upscaling treatment / escape medication
    - Treatment costs
    - Quality of life
    - Biomarkers, cell types and microbiome in colon biopsies
    - Fecal Volatile Organic Compounds (VOC's)
    - Fecal microbiome sequencing
    - RAC genotypes in blood samples
    - Optreden van (ernstig) ongewenste voorvallen ((S)AE's)
    - Leukocytentelling
    - Leverfunctietesten
    - Optreden van subjectieve thiopurine intolerantie
    - 6-TGN levels
    - 6-MMP levels
    - Optreden van falen van de behandeling
    - Optreden van opvlammingen en het opschalen van de behandeling / starten van escape medicatie
    - Behandelingskosten
    - Kwaliteit van leven
    - Biomarkers, cell typen en microbioom in biopten
    - Fecal Volatile Organic Compounds (VOC's)
    - Feces microbioom
    - RAC genotypen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Different time-points during one year of treatment.
    Verschillende meetmomenten gedurende een jaar behandeling.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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
    LVLS
    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 months
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 2016-02-15. 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 state136
    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 current treatment guidelines.
    Volgens de huidige geldende richtlijnen.
    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 Decision2016-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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