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    Summary
    EudraCT Number:2018-003524-36
    Sponsor's Protocol Code Number:6746101818
    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:2018-11-19
    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 number2018-003524-36
    A.3Full title of the trial
    Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa.
    Gerandomiseerd, multicenter onderzoek om computer-berekend gepersonaliseerde inductie-doseringen van infliximab te vergelijken met standaard inductie- doseringen bij patiënten met acute colitis ulcerosa.
    A.3.2Name or abbreviated title of the trial where available
    TITRATE
    A.4.1Sponsor's protocol code number6746101818
    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 SponsorUMC Amsterdam location AMC
    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 supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Amsterdam location AMC
    B.5.2Functional name of contact pointIBD trial office
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205651125
    B.5.5Fax number0031205669285
    B.5.6E-mailibdstudies@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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssens Biologics B.V.
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.IMP: 2
    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 Metoject
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    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
    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 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.IMP: 3
    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 Puri-Nethol
    D.2.1.1.2Name of the Marketing Authorisation holderAspen pharma
    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 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
    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 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
    The objective of this study is to investigate whether intensive, personalized IFX dosing by using a pharmacokinetics driven dashboard system during the induction phase in patients with acute severe UC leads to increased treatment success (as defined by sustained clinical response and endoscopic response at week 6) as compared to the standard dosing.
    E.2.2Secondary objectives of the trial
    -Proportion of patients in remission at week 6 and 26 as measured by the Mayo score
    -Proportion of patients with response at week 6 and 26 as measured by the Mayo score
    -Proportion of patients in clinical remission at week 6 and 26 as measured by the Simple Clinical Colitis Activity Index
    -Proportion of patients in corticosteroid-free remission at week 26 as measured by the Simple Clinical Colitis Activity Index
    -Proportion of patients with clinical remission measured by the Lichtiger scale at week 6 and 26
    -Proportion of patients in biochemical remission at week 6 and 26
    -Proportion of patients with endoscopic response as measured by the Mayo endoscopic subscore
    -Proportion of patients with endoscopic remission at week 6 and 26 as measured by the UCEIS
    -Proportion of patients with mucosal healing at week 6 and 26 as measured by the Mayo endoscopic subscore
    -Proportion of patients with complete mucosal healing at week 6 and 26




    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult UC patients (≥18 years)
    2. Admission with acute severe UC (defined patients with bloody diarrhoea ≥ 6/day and any signs of systemic toxicity (pulse > 90/min, temperature > 37.8°C, haemoglobin < 105 g/l, erythrocyte sedimentation rate [ESR] > 30 mm/h, or C-reactive protein [CRP] > 30 mg/l)
    3. Failure to intravenous steroid treatment as defined by the Oxford criteria (more than 8 stools/d or 3-8 stools/d and CRP≥45 on day 3 after starting iv steroid treatment)
    4. Patients going through baseline endoscopy and biopsy sampling (including CMV) before starting on IFX treatment
    5. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    6. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
    7. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
    E.4Principal exclusion criteria
    1. Patients at imminent need of surgery as judged by the treating clinician
    2. Previous use of IFX
    3. Enteric pathogens (such as Salmonella, Shigella, Yershinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening
    4. Active participation in another interventional trial
    5. Patients with Crohn’s disease or IBD-U
    6. Patients with abdominal abscess
    7. Patients with colonic stricture
    8. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed
    9. Active or latent tuberculosis (screening according to national guidelines)
    10. Cardiac failure in NYHA stage III-IV
    11. History of demyelinating disease
    12. Recent live vaccination
    13. Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV
    14. History of cancer in the last 5 years with the exception of non-melanoma skin cancer
    15. A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures
    16. Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures
    17. Patients unable to attend all study visits
    18. Patients with a history of non-compliance with clinical study protocols
    19. Contraindication for endoscopy
    20. Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer
    21. Patients who received cyclosporine in the previous 14 days
    22. Pregnancy and lactation
    E.5 End points
    E.5.1Primary end point(s)
    Treatment success at week 6, defined as a combination of
    • clinical response (defined as a Lichtiger score of < 10 points with a decrease of at least 3 points compared to baseline) AND
    • endoscopic response (defined as a decrease of at least 2 points in the UCEIS at week 6 endoscopy compared to baseline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    - Proportion of patients in remission at week 6 and 26 as measured by the Mayo score (Mayo score ≤ 2 with no individual subscore >1)
    - Proportion of patients with response at week 6 and 26 as measured by the Mayo score (decrease in Mayo score ≥ 3 points and ≥30% from baseline and a decrease in the rectal bleeding subscore ≥1 or an absolute rectal bleeding subscore of 0 or 1)
    - Proportion of patients in clinical remission at week 6 and 26 as measured by the Simple Clinical Colitis Activity Index (SCCAI score ≤ 2)
    - Proportion of patients in corticosteroid-free remission at week 26 as measured by the Simple Clinical Colitis Activity Index (SCCAI score ≤ 2)
    - Proportion of patients with clinical remission measured by the Lichtiger scale at week 6 and 26 (Lichtiger score ≤ 3)
    -Days in clinical response (defined as Lichtiger score of <10 points with a decrease of at least 3 points compared to baseline) and remission ( defined as Lichtiger score < 3) throughout week 0-6
    - Proportion of patients in biochemical remission at week 6 and 26 (CRP ≤ 5.0 mg/L and fecal calprotectin < 250 mg/g)
    - Proportion of patients with endoscopic response as measured by the Mayo endoscopic subscore (≥1 point improvement) at week 6 and 26
    - Proportion of patients with endoscopic remission measured by the UCEIS (UCEIS 1 point on all descriptors)
    - Proportion of patients with mucosal healing at week 6 and 26 as measured by the Mayo endoscopic subscore (eMayo 0 or 1)
    - Proportion of patients with complete mucosal healing at week 6 and 26 as measured by the Mayo endoscopic subscore (eMayo 0)
    - Degree of histological improvement at week 6 and 26 compared to baseline as defined by the Robarts histopathology index
    - Proportion of patients reaching minimally clinically important difference in quality of life at week 6 and week 26 compared to baseline as assessed by the IBDQ and EQ-5D-5L questionnaire
    - Colectomy rates at week 26
    - Total IFX dosing (mg/kg) until week 26
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6 and week 26
    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 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 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
    same medicinal substance but as standard dosing
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 98
    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)
    The treatment continues as standard treatment
    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 Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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