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    Summary
    EudraCT Number:2014-003262-25
    Sponsor's Protocol Code Number:MK8259-022
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-20
    Trial results View 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 ConcernedPortugal - INFARMED
    A.2EudraCT number2014-003262-25
    A.3Full title of the trial
    An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab
    A.3.2Name or abbreviated title of the trial where available
    EVOLUTION
    A.4.1Sponsor's protocol code numberMK8259-022
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Lda
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressMerck (UG3D-66) 351 North Sumneytown Pike
    B.5.3.2Town/ cityNorth Wales
    B.5.3.3Post codePA 19454
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12673055921
    B.5.6E-mailgeorge_philip@merck.com
    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 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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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] - Immune System Diseases [C20]
    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 evaluate the correlation of serum soluble ST2 levels with endoscopic activity (endoscopic Mayo score) at week 6 in moderate to severe UC subjects under golimumab
    treatment.

    - To evaluate the correlation of serum soluble ST2 with histological activity (Geboes index) at
    week 6 in moderate to severe UC subjects under golimumab treatment.
    E.2.2Secondary objectives of the trial
    - Evaluate correlation of serum solubleS T2 levels with endoscopic activity
    (Mayo score) at Wk16 in moderate to severe UC subjects under golimumab
    - Evaluate correlation of serum soluble ST2 levels with histological activity (Geboes
    index) at week 16 in moderate to severe UC subjects under golimumab
    - Correlate serum soluble ST2 levels with fecal calprotectin, at wk 6 and wk16 in
    moderate to severe UC subjects under golimumab
    - Correlate serum soluble ST2 with clinical activity (total Mayo score) at wk6 and wk16 in moderate to severe UC subjects under golimumab
    - Evaluate the potential of serum soluble ST2 as a predictor of endoscopic response
    (endoscopic Mayo score) to golimumab in moderate to severe UC subjects
    - Evaluate correlation between serum soluble ST2 levels with maintenance of
    endoscopic response (endoscopic Mayo score) to golimumab
    - Correlate Mayo endoscopic score with UCEIS overall score at wk6 and wk16 in
    moderate to severe UC subjects under golimumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood)
    specimens collected during this clinical trial. Such research is for
    biomarker testing to address emergent questions not described
    elsewhere in the protocol (as part of the main trial) and will only be
    conducted on specimens from appropriately consented subjects. The
    objective of collecting specimens for Future Biomedical Research is to
    explore and identify biomarkers that inform the scientific understanding
    of diseases and/or their therapeutic treatments. The overarching goal is
    to use such information to develop safer, more effective drugs, and/or to
    ensure that subjects receive the correct dose of the correct drug at the
    correct time.
    E.3Principal inclusion criteria
    Subjects with a diagnosis of moderate to severe ulcerative colitis will be selected to participate in the trial.

    Inclusion criteria: Age 18 years or older at time of enrollment; diagnosis of moderate to severe ulcerative colitis at inclusion (defined as a clinical Mayo score ≥6) including endoscopy that shows inflammation as judged by a Mayo endoscopy score ≥2; subject is eligible to receive golimumab as per product monograph; signed the informed consent
    E.4Principal exclusion criteria
    Exclusion criteria: as per golimumab’s product monograph; history of asthma, autoimmune
    diseases, hypertension.
    E.5 End points
    E.5.1Primary end point(s)
    - endoscopic activity of disease (measured by endoscopy Mayo subscore) at 6 weeks in UC
    subjects receiving golimumab;
    - histological activity (measured by Geboes index score) at 6 weeks in UC subjects receiving
    golimumab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    E.5.2Secondary end point(s)
    - the correlation between serum soluble ST2 with endoscopic activity of disease (measured
    by endoscopy Mayo subscore) at 16 weeks in UC subjects receiving golimumab, through
    the Spearman correlation coefficient;

    - the correlation between serum soluble ST2 histological activity (measured by Geboes index
    score) at 16 weeks in UC subjects receiving golimumab, through the Spearman correlation
    coefficient.

    - Serum soluble ST2 levels at baseline, Week 6 and Week 16 will be correlated with fecal
    calprotectin levels at baseline, week 6 and week 16 through Pearson correlation coefficient
    or Spearman correlation coefficient in case the normality assumption is not verified. The two
    biomarkers will be categorized by the cut-offs and Cohen's kappa coefficient will be
    obtained.

    - Serum soluble ST2 levels at baseline, week 6 and week 16 will be correlated with clinical
    activity (total Mayo score), through Spearman correlation coefficient.

    - Comparative analyses of means (active disease versus inactive disease at week 6) with
    serum ST2 at baseline and change between baseline and week 6.

    - Comparative analyses of subjects who achieved response at week 6 and maintained
    through week 16 versus subjects who did not maintain response, regarding serum soluble
    ST2 at baseline, week 6 and change between baseline and week 6. ROC curve analysis of
    the serum soluble ST2 at week 6 regarding maintenance of response between week 6 and
    16 will be performed. This exploratory analysis will detect the cut-off levels of the serum
    soluble ST2 at week 6 associated with maintenance of response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 weeks
    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 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
    correlation of serum soluble ST2 levels
    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 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 No
    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 concerned9
    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 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: 37
    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 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 state37
    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 followed according to regular clinical practice after the ending of the trial. Golimumab is available for the treatment of ulcerative colitis patients
    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 Decision2014-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-05
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