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    Summary
    EudraCT Number:2022-000837-17
    Sponsor's Protocol Code Number:NL80854.018.22
    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:2022-09-29
    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 number2022-000837-17
    A.3Full title of the trial
    Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lengthening of vedolizumab injections based on drug concentrations in patients with inflammatory bowel disease
    A.3.2Name or abbreviated title of the trial where available
    SILVER-study
    A.4.1Sponsor's protocol code numberNL80854.018.22
    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 SponsorAmsterdam UMC
    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 supportAmsterdam UMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointIBD Trialbureau
    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 number+31205666545
    B.5.6E-mailibdstudies@amsterdamumc.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 Vedolizumab, Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    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
    Inflammatory bowel diseases (Crohn's disease, ulcerative colitis)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory diseases of the bowel
    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
    Cost-effectiveness of the TDM-guided de-escalation group compared to the standard dosing group over 48 weeks.
    E.2.2Secondary objectives of the trial
    Proportion of patients with sustained clinical remission (based on Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index), proportion of patients with (sustained) biochemical remission (based on c-reactive protein and fecal calprotectin), pharmacokinetic differences (vedolizumab levels), safety and quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Age 18 or older;
     Diagnosis of CD or UC;
     Clinical and biochemical remission, all three criteria below need to be fulfilled prior to enrolment:
     Absence of active inflammatory intestinal symptoms, as judged by both patient and physician;
     FCP <250 μg/g and CRP <5 mg/L;
     HBI <5 (CD) or SCCAI <4 (UC).
     Steroid-free remission for ≥6 months whilst being treated with SC vedolizumab at a stable dose (108 mg every 2 weeks);
    E.4Principal exclusion criteria
     Absence of written informed consent;
     Presence of anti-drug antibodies against vedolizumab;
     Concomitant oral glucocorticosteroid usage;
     Imminent need for IBD-related surgery as judged by the treating clinician;
     Actively draining peri-anal fistula;
     Patients with short bowel syndrome, an ostomy or a symptomatic stricture;
     Active participation in another interventional trial;
     Pregnancy or lactation;
     Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness);
     Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy.
    E.5 End points
    E.5.1Primary end point(s)
    - To evaluate whether the SC vedolizumab ‘TDM-guided de-escalation’ strategy using capillary blood measurements will be cost effective, when compared to the standard dosing regimen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8, 18, 28, 38 and 48 weeks after inclusion
    E.5.2Secondary end point(s)
    - Proportion of patients with clinical remission (Harvey-Bradshaw Index (HBI) <5 in CD, Simple Clinical Colitis Activity Index (SCCAI) <4 in UC), 28 and 48 weeks after inclusion;
    - Proportion of patients with sustained clinical remission (persistent clinical remission from the start of the trial) 28 and 48 weeks after inclusion;
    - Proportion of patients with biochemical remission (fecal calprotectin (FCP) ≤250 μg/g and c-reactive protein (CRP) ≤5 mg/L) 48 weeks after inclusion;
    - Proportion of patients with combined remission (clinical and biochemical) 48 weeks after inclusion;
    - Proportion of patients with clinical relapse (HBI ≥5 in CD or SCCAI ≥4 in UC for two consecutive weeks) and time to clinical relapse;
    - Proportion of patients in the intervention group that still is in the TDM-guided de-escalation group 8, 18, 28, 38 and 48 weeks after inclusion;
    - Number of visits to the emergency room, hospitalization and surgical interventions;
    - HBI (in CD) or SCCAI (in UC) score and patient-reported outcome measures (PROM) by PRO-2: 8, 18, 28, 38 and 48 weeks after inclusion;
    - Quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ), EQ-5D-5L);
    - CRP and FCP 48 weeks after inclusion;
    - Vedolizumab concentrations. All patients: serum vedolizumab concentrations at screening and 48 weeks after inclusion. Intervention group: vedolizumab capillary concentrations according to schedule (4. Study design);
    - Formation of anti-drug antibody against vedolizumab at week 24 and 48.
    - Adverse event rates (including injection site reactions, infections and other adverse events linked to biological therapy).
    E.5.2.1Timepoint(s) of evaluation of this end point
    8, 18, 28, 38 and 48 weeks after inclusion
    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 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 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) 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
    controlled by a group of patients that continue regular dosing scheme
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The endo of the trial is 48 weeks after inclusion.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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 the last study visit, patients will return to their own gastroenterologist for regular follow-up at the outpatient clinic. Their own physician will determine, in consultation with the study team and the patient, what the interval of the subcutaneous vedolizumab will be after the trial has ended.
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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