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    Summary
    EudraCT Number:2019-003987-37
    Sponsor's Protocol Code Number:2019-001G
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-27
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2019-003987-37
    A.3Full title of the trial
    Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens
    Primerjava farmakokinetike in farmakodinamike različnih odmerkov golimumaba pri pacientih z ulceroznim kolitisom na vzdrževalnem zdravljenju z golimumabom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis
    Primerjava dveh različnih shem odmerjanja golimumaba pri ulceroznem kolitisu
    A.4.1Sponsor's protocol code number2019-001G
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04156984
    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 SponsorUniversity Medical Centre Ljubljana, Department of gastroenterology
    B.1.3.4CountrySlovenia
    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 supportUniversity Medical Centre Ljubljana, Department of gastroenterology
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Ljubljana, Department of gastroenterology
    B.5.2Functional name of contact pointDepartment of Gastroenterology
    B.5.3 Address:
    B.5.3.1Street AddressJapljeva 2
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number+38615221552
    B.5.5Fax number+38614334190
    B.5.6E-maildavid.drobne@kclj.si
    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.2.1.1.1Trade name Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSimponi
    D.3.2Product code CNTO-148
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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
    Ulcerative colitis
    Ulcerozni kolitis
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease - ulcerative colitis
    Kronična vnetna črevesna bolezen - ulcerozni kolitis.
    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
    To compare endoscopic outcomes of high dose induction/maintenance golimumab therapy (200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4wk) with current practice (50 mg in patients >80kg BW and 100 mg sc in patients with ≥ 80kg BW q4wk) in moderate to severe ulcerative colitis.
    Ugotoviti ali zgodnja optimizacija odmerka golimumaba na 100 mg sc/4 tedne (ne glede na telesno maso) vpliva na endoskopsko remisijo pri pacientih z aktivnim ulceroznim kolitisom v primerjavi s trenutnim odmerjanjem, kjer se pri pacientih z >80 kg TT odmerek dvigne iz 50 mg sc/4 tedne na 100 mg sc/4 tedne samo ob nezadostnem kliničnem odgovoru. Paciente z ≥80 kg TT se že takoj začne zdraviti z odmerkom 100 mg sc/4 tedne.
    E.2.2Secondary objectives of the trial
    1) To compare clinical outcomes of high dose induction/maintenance golimumab therapy (200 mg sc, followed by 100 mg sc at week 2 and then 100 mg sc q4wk) with current practice (50 mg in patients >80kg BW and 100 mg sc in patients with ≥ 80kg BW q4wk) in moderate to severe ulcerative colitis.

    2) To assess if development of anti-golimumab antibodies affects endoscopic outcomes in patients treated with golimumab.

    3) To assess if development of anti-golimumab antibodies affects clinical outcomes in patients treated with golimumab.

    4) Measurement of physical, social, and emotional status with The Short Inflammatory Bowel Disease Questionnaire.

    5) Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0.
    1) Ugotoviti ali zgodnja optimizacija odmerka golimumaba na 100 mg sc/4 tedne (ne glede na telesno maso) vpliva na klinično remisijo pri pacientih z aktivnim ulceroznim kolitisom v primerjavi s trenutnim odmerjanjem, kjer se pri pacientih z >80 kg TT odmerek dvigne iz 50 mg sc/4 tedne na 100 mg sc/4 tedne samo ob nezadostnem kliničnem odgovoru. Paciente z ≥80 kg TT se že takoj zažne zdraviti z odmerkom 100 mg sc/4 tedne.

    2) Ugotoviti ali pojav anti-golimumabnih protiteles vpliva na endoskopsko remisijo pri pacientih zdravljenih z golimumabom.

    3) Ugotoviti ali pojav anti-golimumabnih protiteles vpliva na klinično remisijo pri pacientih zdravljenih z golimumabom.

    4) Oceniti kvaliteto življenja pacientov zdravljenih z golimumabom.

    5) Oceniti varnost in incidenco stranskih učinkov povezanih z zdravljenjem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Histologicaly confirmed ulcerative colitis

    2) age <18 years old
    1) Histološko potrjen ulcerozni kolitis

    2) Starost >18 let
    E.4Principal exclusion criteria
    1) History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.

    2) Active tuberculosis or other opportunistic bacterial, viral and fungal infections.

    3) History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure .

    4) Pregnancy.
    1) Preobčutljivost na učinkovino golimumab ali katerokoli pomožno snov (sorbitol (E420), L-histidin, L-histidinijev klorid monohidrat, Polisorbat 80, voda za injekcije).

    2) Aktivna tuberkuloza ali druge hude okužbe, kot so sepsa in oportunistične okužbe.

    3) Zmerno ali hudo srčno popuščanje (NYHA III ali IV).

    4) Nosečnost.
    E.5 End points
    E.5.1Primary end point(s)
    1) Endoscopic outcome: Number of participants with mucosal healing at week 14 and week 50 on flexible rectosigmoidoscopy (recorded and assessed centrally by blinded reader if possible). Mucosal healing is defined as Mayo endoscopic score 0 or 1.
    1) Endoskopski izhod: Oceniti število bolnikov v endoskopski remisiji v 14. in 50. tednu. Endoskopska remisija bo ocenjena s fleksibilno rektosigmoidoskopijo. Preiskava bo posneta, če bo le možno jo bo pregledal on ocenil neodvisni endoskopist, ki ne bo imel podatkov o pacientu. Remisija je definirana kot Mayo endoscopic score 0 ali 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Endoscopic outcome: Number of participants with mucosal healing at week 14 and week 50
    1) Endoskopski izhod: Oceniti število bolnikov v endoskopski remisiji v 14. in 50. tednu.
    E.5.2Secondary end point(s)
    1) Clinical outcome: Number of participants in clinical remission at week 14, week 26, week 38 and week 50. Clinical remission is defined as PRO-2 (Patient-Reported Outcome) score 0 (no rectal bleeding and no diarrhea/altered bowel habit).

    2) Association of golimumab through levels and Anti-golimumab antibodies development on endoscopic and clinical outcome.

    2a) Measurement of golimumab through levels. Blood withdrawals will be preformed at prespecified time points in all patients: week 0, week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50.

    2b) Measurement of Anti-golimumab antibodies development. Blood withdrawals will be preformed at prespecified time points in all patients: week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50.

    3) Measurement of physical, social, and emotional status with The Short Inflammatory Bowel Disease Questionnaire.

    The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life (HRQoL) tool measuring physical, social, and emotional status (score 10-70, poor to good HRQoL). The questionnaire will be answered at week 0, week 6, week 14, week 26, week 38, week 50.

    4) Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 - Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
    1) Ocena klinične remisije (brez zagona bolezni): Število bolnikov v klinični remisiji v 14., 26., 38. in 50. tednu. Klinična remisija je definirana kot PRO-2 = 0 točk (brez proktoragije ali driske/spremembe v odvajanju blata.

    2) Povezava serumske koncentracije golimumaba pred aplikacijo in povezava pojava proti-golimumabnih protiteles z endoskopskim in kliničnim izhodom.

    2a) Izmeritev serumske koncentracije golimumaba pred aplikacijo pri vseh pacientih v naprej določenih intervalih: teden 0, 2, 4, 6, 10, 14, 26, 38 in 50.

    2b) Izmeriti prisotnost proti-golimumabnih protiteles pri vseh pacientih v naprej določenih intervalih: teden 0, 2, 4, 6, 10, 14, 26, 38 in 50.

    3) Ocena kvalitete življenja (The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)). S tem vprašalnikom bomo ocenili fizični, socialni in emocionalni status. Pacienti bodo odgovarjali na vprašalnik v tednu 0, 6, 14, 26, 38 in 50.

    4) Incidenca nezaželenih sopojavov, ki so posledica zdravljenja z golimumabom (CTCAE v4.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Clinical outcome: Number of participants in clinical remission at week 14, week 26, week 38 and week 50.

    2a and b) Golimumab trough level and antibody measurements: week 0, week 2, week 4, week 6, week 10, week 14, week 26, week 38 and week 50.

    3) The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) will be answered at week 0, week 6, week 14, week 26, week 38, week 50.

    4) Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0. (anytime during treatment)
    1) Klinični izhod: Število bolnikov v remisiji v 14., 26., 38. in 50. tednu.

    2a in b) Serumska koncentracija golimumaba pred aplikacijo in prisotnost protiteles proti golimumabu: teden 0, 2, 4, 6, 10, 14, 26, 38 in 50.

    3) Ocena kvalitete življenja (The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)). Pacienti bodo odgovarjali na vprašalnik v tednu 0, 6, 14, 26, 38 in 50.

    4) Incidenca nezaželenih sopojavov, ki so posledica zdravljenja z golimumabom (CTCAE v4.0) (stalno spremljanje)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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
    Drugačen odmerek golimumaba.
    Different dose of golimumab.
    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 concerned4
    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.
    Zadnji obisk pacienta.
    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
    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: 30
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state30
    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)
    Patients will be given the same dose of golimumab as in the trial. In the case of a flare they will be treated according to the normal clinical practice.
    Bolniki bodo še naprej zdravljeni z zdravilom v odmerku, ki so ga prejemali v raziskavi. V primeru odpovedi terapije bodo zdravljeni po ustaljeni klinični praksi.
    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 Decision2020-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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