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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001594-14
    Sponsor's Protocol Code Number:FITC-ADA-CU-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-22
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-001594-14
    A.3Full title of the trial
    Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment
    Prospektive, monozentrische, offene, einarmige klinische Prüfung der Phase I/IIa zum Nachweis der Sicherheit und Verträglichkeit und zur Untersuchung der prädiktiven Aussagekraft von FITC-Adalimumab bei zweimaliger topischer Applikation auf der intestinalen Schleimhaut als in vivo-Diagnostikum im Rahmen der konfokalen laserendomikroskopischen Untersuchung von Patienten mit Indikation zur Adalimumab-Therapie bei Colitis ulcerosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site
    Kann FITC-Adalimumab die Wirksamkeit von Adalimumab bei Colitis ulcerosa vorhersagen, wenn es im Rahmen einer endoskopischen Untersuchung auf die Darmschleimhaut aufgesprüht wird? Ist FITC-Adalimumab dabei sicher und verträglich? Offene, einarmige klinische Studie in einem Studienzentrum
    A.3.2Name or abbreviated title of the trial where available
    MAgIC
    A.4.1Sponsor's protocol code numberFITC-ADA-CU-01
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportMedizinische Klinik I, Universitätsklinikum Erlangen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointDirektion, Medizinische Klinik I
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number+4991318535204
    B.5.5Fax number+4991318535209
    B.5.6E-mailmarkus.neurath@uk-erlangen.de
    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 No
    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 nameFITC-Adalimumab
    D.3.2Product code FITC-Adalimumab
    D.3.4Pharmaceutical form Gastroenteral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFITC-Adalimumab
    D.3.9.3Other descriptive nameFITC-ADALIMUMAB
    D.3.9.4EV Substance CodeSUB191206
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Yes
    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 10066678
    E.1.2Term Acute 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
    Safety and tolerability of small doses of FITC-adalimumab after two-time topical application to the intestinal
    mucosa during an endomicroscopic investigation of patients affected by ulcerative colitis
    Primäres Ziel der klinischen Prüfung ist der Nachweis der Sicherheit und Verträglichkeit geringer Dosen von FITC-Adalimumab bei zweizeitiger topischer Anwendung auf der Darmschleimhaut im Rahmen einer endomikroskopischen Untersuchung von Patienten mit klinisch und endoskopisch aktiver Colitis ulcerosa.
    E.2.2Secondary objectives of the trial
     Quantification of mTNF-expressing mucosal cells
     Predictive power for response to adalimumab treatment
     Die Überprüfung der Eignung von topisch auf die Darmschleimhaut appliziertem FITC-Adalimumab zur quantitativen Bestimmung von mTNF-exprimierenden intestinalen Zellen in vivo bei Patienten mit klinisch und endoskopisch aktiver Colitis ulcerosa.
     Die Überprüfung der Eignung von topisch auf die Darmschleimhaut appliziertem FITC-Adalimumab zur Prädiktion des Ansprechens auf eine Therapie mit Adalimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Able to give informed consent
     Insufficient response or contra-indications to systemic treatment with glucocorticoids or immunosuppressive agents or glucocorticoid dependency
     If concomitant medication,
    • Systemic glucocorticoids ≥20 mg/d prednisolon equivalent: stable for one week at least
    • Systemic glucocorticoids <20 mg/d prednisolon equivalent: stable for one week at least
    • MMX budesonid (9mg/day) stable for eight weeks at least
    • 5-aminosalicylate: stable dose for two weeks at least and initiated since eight weeks at least
    • Immunsuppressive agents (except ciclosporine A and tacrolimus): treatment for three months at least and stable dose for eight weeks at least prior to enrolment
     For subjects with child-bearing potential: adequate contraception
    uneingeschränkt aufklärungs- und einwilligungsfähig
    Vorliegen der schriftlichen Einwilligung der Patientin/des Patienten nach erfolgter Aufklärung durch den Prüfer bzw. ein sonstiges ärztliches Mitglied der Prüfgruppe
    Klinisch ungenügendes Ansprechen auf bzw. Kontraindikationen gegen eine systemische Therapie mit Glukokortikoiden oder Immunsuppressiva oder glukokortikoidabhängiger Verlauf
    Falls Begleittherapie vorhanden, dann unter den folgenden Bedingungen
    • Systemische Glukokortikoide ≥20 mg/d Prednisolon-Äquivalent: stabil seit mindestens einer Woche
    • Systemische Glukokortikoide <20 mg/d Prednisolon-Äquivalent: stabil seit mindestens einer Woche
    • MMX Budesonid (9 mg/Tag): stabil seit mindestens acht Wochen
    • 5-Aminosalizylate: stabile Dosierung seit mindestens zwei Wochen und initiiert seit mindestens acht Wochen
    • Immunsuppressiva (außer Ciclosporin A und Tacrolimus): Therapie seit mindestens drei Monaten und dabei stabile Dosierung über mindestens acht Wochen vor Studieneinschluss
    Für Patientinnen im gebärfähigen Alter: adäquate Kontrazeption
    E.4Principal exclusion criteria
    Colitis of unclear origin
    Stenosis within the Framework of colitis ulcerosa
    Fulminant course of disease
    Toxic megacolon
    Colectomy (done or planned), ileo-anal pouch, ileorectostomy or ileostoma
    Proctitis only
    Pre-treatment with adalimumab
    Administration of vedolizumab, anti-TNF treatment within the last four weeks prior to enrolment
    Administration of methotrexate, ciclosporine A or tacrolimus within the last eight weeks prior to enrolment
    Compromised coagulation (Quick <50% and/or PTT >55 sec and/or thrombocytes <50.000/μl)
    Pregnant or breast-feeding female
    Contraindications for adalimumab treatment
    Known hypersensitivity to an ingredient of the IMP or to a MP with similar chemical structure
    Unklare Colitis mit in Frage kommenden Differentialdiagnosen wie M. Crohn, ischämische Colitis, infektiöse Colitis
    Stenose im Rahmen der Colitis ulcerosa
    Fulminante Verlaufsform
    Toxisches Megakolon
    Kolektomie (auch geplante Kolektomie), Anlage eines Ileo-analen Pouches, einer Ileorektostomie oder eines Ileostomas
    Alleinige Proktitis
    Vorbehandlung mit Adalimumab
    Gabe von Vedolizumab, anti-TNF-Therapie innerhalb der letzten vier Wochen vor Studieneinschluss
    Gabe von Methotrexat, Ciclosporin A oder Tacrolimus innerhalb der letzten acht Wochen vor Studieneinschluss
    Eingeschränkte Blutgerinnung (Quick–Wert <50% und/oder PTT >55 sec und/oder Thrombozyten <50.000/μl)
    Schwangerschaft und Stillzeit
    Kontraindikationen für eine Therapie mit Adalimumab
    Bekannte Überempfindlichkeit gegenüber einem der Inhaltsstoffe des Prüfpräparats oder gegenüber Arzneimittel mit ähnlicher chemischer Struktur
    E.5 End points
    E.5.1Primary end point(s)
     ARs grade ≥2 at the site of FITC-adalimumab administration
     AEs, ARs, SAEs and SARs during the course of the study
     Auftreten von ARs Grad ≥2 an der mit FITC-Adalimumab markierten intestinalen Schleimhaut nach Applikation des Prüfpräparates
     Auftreten von AEs, ARs, SAEs und SARs im Beobachtungszeitraum
    E.5.1.1Timepoint(s) of evaluation of this end point
     Up to 24 hours after IMP administration
     Visit 2 (after IMP administration) to visit 7
     Bis max. 24 Stunden nach Applikation des Prüfpräparates
     Visite 2 nach Applikation des Prüfpräparates bis Visite 7
    E.5.2Secondary end point(s)
     Number of m-TNF expressing intestinal cells after IMP administration.
     Number and percentage of patients responding to adalimumab treatment.
     Number and percentage of patients entering remission.
     Number and percentage of patients with endoscopic mucosal healing.
     Riley score, Nancy index and glucocorticoid dose.
     Calprotektin value.
     Adalimumab concentration and presence of antibody against adalimumab in serum.
     Anzahl m-TNF-exprimierender intestinaler Zellen nach Markierung mit FITC-Adalimumab in vivo ).
     Anzahl und Anteil der Patienten, die auf eine Therapie mit Adalimumab ansprechen/nicht ansprechen.
     Anzahl und Anteil der Patienten, die sich in Remission befinden/nicht in Remission befinden.
     Anzahl und Anteil der Patienten, bei denen endoskopisch ein mucosal healing nachweisbar/nicht nachweisbar ist.
     Riley Score, Nancy Index und Glukokortikoid-Dosis.
     Calprotektin-Wert.
     Adalimumab-Konzentration und –Antikörper im Serum.
    E.5.2.1Timepoint(s) of evaluation of this end point
     At visit 2 (Day 1) and visit 5 (Day 64±4 days).
     At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days).
     At visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days).
     At visit 5 (Day 64±4 days) and at visit7 (Day 372±14 days).
     At visit 2 (Day 1), visit 5 (Day 64±4 days) and at visit 7 (Day 372±14 days).
     At visit 1 (Day -7±6 days), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days).
     At visit 4 (Day 22±2), at visit 5 (Day 64±4 days), at visit 6 (Day 176±7 days) and at visit 7 (Day 372±14 days).
     Zu Visite 2 (Tag 1) und Visite 5 (Tag 64±4 Tage).
     Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
     Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
     Zu Visite 5 (Tag 64±4 Tage) und zu Visite 7 (Tag 372±14 Tage).
     Zu Visite 2 (Tag 1), Visite 5 (Tag 64±4 Tage) und Visite 7 (Tag 372±14 Tage).
     Zu Visite 1 (Tag -7±6 Tage), zu Visite 5 (Tag 64±4 Tage), zu Visite 6 (Tag 176±7 Tage) und zu Visite 7 (Tag 372±14 Tage).
     Zu Visite 4 (Tag 22±2), zu Visite 5 (Tag 64±4 Tage), zu Visite 6 (Tag 176±7 Tage) und zu Visite 7 (Tag 372±14 Tage).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Assessment of safety and tolerability in patients affected by ulcerative colitis
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state25
    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)
    Standard treatment in accordance with the guideline of the Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten.
    Standardbehandlung entsprechend der Leitlinie der Deutschen Gesellschaft für Verdauungs- und Stoffwechselkrankheiten.
    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 Decision2017-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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