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    Summary
    EudraCT Number:2019-002041-38
    Sponsor's Protocol Code Number:SafE-OrBi
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-002041-38
    A.3Full title of the trial
    Evaluation of the Safety and Effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in Flanders (SafE-OrBi)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Safety and Effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in Flanders (SafE-OrBi)
    A.3.2Name or abbreviated title of the trial where available
    SafE-OrBi
    A.4.1Sponsor's protocol code numberSafE-OrBi
    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 SponsorAZ Maria Middelares
    B.1.3.4CountryBelgium
    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 supportBiogen Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZ Maria Middelares
    B.5.2Functional name of contact pointDatamanager Digestief Centrum
    B.5.3 Address:
    B.5.3.1Street AddressBuitenring Sint-Denijs 30
    B.5.3.2Town/ cityGent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number329246 71 41
    B.5.6E-mailnina.vanheddegem@azmmsj.be
    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 Imraldi
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis NL B.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 and suspension for suspension for injection in pre-filled syringe
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 typeImmunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors
    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 and Ulcerative Colitis)
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Diseases
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021184
    E.1.2Term IBD
    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
    Description of adalimumab (ADA) trough level over time after the transition from Humira® to Imraldi®.
    E.2.2Secondary objectives of the trial
    • To evaluate the possible association between adalimumab trough level and Secondary Loss of Response (SLOR)
    • To describe disease activity and objective disease markers over time
    • To summarize incidence of treatment-emergent safety events i.e. all serious adverse events (SAEs); all non-serious adverse events (AE) with possible causal relationship with adalimumab during the study period.
    • To investigate patient acceptance of switching from Humira® to Imraldi®
    • To investigate patient satisfaction with biologic therapy (Baseline, Week 8, Month 6 and Month 12)
    • To describe persistence on Imraldi® after the transition from Humira® to Imraldi®
    • To explore the reasons leading to Imraldi® discontinuation
    • To describe baseline characteristics of a well-defined cohort of IBD patients on Humira® and to describe possible associations between patient / disease characteristics and acceptance of switch
    • To evaluate co-medication (co-immunomodulatory drugs, corticosteroids) over time
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adult patients (≥ 18 years of age)
    2) Ulcerative Colitis or Crohn’s disease
    3) Maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®
    4) Able to communicate in Flemish, French or English
    5) Able and willing to voluntarily participate in the study and to provide written informed consent.
    6) Informed consent form signed
    E.4Principal exclusion criteria
    1) Patient currently included in an interventional study
    2) Pregnant or breastfeeding patient
    E.5 End points
    E.5.1Primary end point(s)
    Adalimumab (ADA) trough level at Baseline (transition)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8, Month 6 and Month 12.
    E.5.2Secondary end point(s)
    1)Association of adalimumab (ADA) trough level with clinical outcome (SLOR)
    2)Disease activity scores (Crohn’s Disease Activity Index (CDAI) and Mayo clinical subscore), physician Global Assessment (PGA) and objective disease markers (CRP, faecal calprotectin, leucocyte count)
    3)Adverse Events (AEs) with a possible/probable causal relationship with adalimumab and/or all Serious Adverse Events (SAEs)
    4)Patient acceptance of the switch from Humira® to Imraldi® measured by VAS
    5)VAS to measure patient satisfaction with biologic treatment at baseline
    6)Persistence on Imraldi®
    7)Discontinuation of Imraldi® due to loss of effectiveness, adverse event, presence of anti-ADA antibodies, patient/physician decision
    8)Clinical characteristics (age, gender, IBD diagnosis and Montreal Classification, duration of disease, relevant comorbidity, surgical history, duration of adalimumab use and regimen at switch, smoking status
    9)Concomitant therapy (co-immunomodulatory agents, corticosteroids)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at Month 12
    2) at Baseline, Week 8, Month 6 and Month 12
    3) during the study period
    4) at Baseline, Week 8 and Month 6.
    5) at baseline, Week 8 and Month 6
    6) at Week 8, Month 6 and Month 12
    8) at baseline
    9) during the study period
    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 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 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 concerned2
    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 years1
    E.8.9.1In the Member State concerned months5
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state170
    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 is under prescription and can be continued after the end of the study
    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 Decision2019-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
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