Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37989   clinical trials with a EudraCT protocol, of which   6231   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-002311-41
    Sponsor's Protocol Code Number:2014-3
    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:2017-12-18
    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 number2014-002311-41
    A.3Full title of the trial
    A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.
    Een prospectief, gerandomiseerd, gecontroleerd, onderzoek waarbij infliximab-antimetabolieten combinatie therapie wordt vergeleken met antimetabolieten mono therapie en infliximab mono therapie in patienten met de ziekte van Crohn in volgehouden steroïden-vrije remissie op combinatie therapie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.
    SPARE
    Een prospectief, gerandomiseerd, gecontroleerd, onderzoek waarbij infliximab-antimetabolieten combinatie therapie wordt vergeleken met antimetabolieten mono therapie en infliximab mono therapie in patienten met de ziekte van Crohn in volgehouden steroïden-vrije remissie op combinatie therapie.
    A.3.2Name or abbreviated title of the trial where available
    GETAID 2014-3 SPARE
    GETAID 2014-3 SPARE
    A.4.1Sponsor's protocol code number2014-3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02177071
    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 SponsorGETAID
    B.1.3.4CountryFrance
    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 supportGETAID
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETAID
    B.5.2Functional name of contact pointBRILLAULT GAELLE
    B.5.3 Address:
    B.5.3.1Street AddressHopital LARIBOISIERE Sce de Gastro enterologie 1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33617044633
    B.5.5Fax number33184108545
    B.5.6E-mailprojet@getaid.org
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 holderMSD FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameINFLIXIMAB
    D.3.4Pharmaceutical form 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 RoleComparator
    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 IMUREL
    D.2.1.1.2Name of the Marketing Authorisation holderHAC PHARMA FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameazathioprine
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 METHOTREXATE
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire BIODIM
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMETHOTREXATE
    D.3.4Pharmaceutical form Concentrate for cutaneous solution
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 PURINETHOL
    D.2.1.1.2Name of the Marketing Authorisation holderH.A.C. Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMERCAPTOPURINE
    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
    Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months
    Crohn patiënten met Luminale ziekte die ten minste 6 maanden in remissie zijn en ten minste 8 maanden een combinatie therapie van infliximab met een anti-metaboliet hebben.
    E.1.1.1Medical condition in easily understood language
    Luminal Crohn’s disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months
    Crohn patiënten met Luminale ziekte die ten minste 6 maanden in remissie zijn en ten minste 8 maanden een combinatie therapie van infliximab met een anti-metaboliet hebben.
    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
    To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and antimetabolites or continued monotherapy with infliximab are both superior to antimetabolites alone for maintaining sustained steroid-free clinical remission, while antimetabolites alone are non-inferior with regards to the mean time spent in remission
    Het effect beoordelen van twee witdrawal strategieën gedurende twee jaar bij patiënten met een stabiele remissie gedurende meer dan 8 maanden op combinatietherapie met infliximab en antimetabolieten, en aantonen dat voortgezette combinatie van infliximab en antimetabolieten of voortgezette monotherapie met infliximab beide superieur zijn aan antimetabolieten alleen voor behouden van aanhoudende steroïde-vrije klinische remissie, terwijl antimetabolieten alleen niet-inferieur zijn met betrekking tot de gemiddelde tijd die men in remissie is.
    E.2.2Secondary objectives of the trial
    To identify baseline predictive factors of relapse in the three study groups. To assess in the three groups: the ability of blood CRP and fecal calprotectin to predict short term relapse in the the groups, time spent in clinical remission, the rate of treatment failure, the time to treatment failure, progression of bowel damage, the evolution of the disability score. To assess the safety and efficacy of infliximab retreatment in the antimetabolites group. To assess in the three study groups: safety, the health related quality of life, direct and indirect costs, evolution of blood CRP and fecal calprotectin. To assess evolution of infliximab trough levels and ATI in the two infliximab scheduled maintenance groups. To assess correlations between a series of biomarkers (proteomics, glycomics, DNA methylation, miRNA, metagenomics) and various clinical and biological outcomes. To assess the impact of 6TGN level on the various clinical and biological outcomes in the purine treated patients
    Om baseline voorspellende factoren van terugval in de 3 studiegroepen te identificeren. Om te beoordelen: het vermogen van bloed-CRP en fecaal calprotectine om terugval op korte termijn in de groepen te voorspellen, tijd doorgebracht in klinische remissie, de mate van en de tijd tot falen van de behandeling, progressie van darmschade, de beloop van de invaliditeitsscore. Om de veiligheid/ werkzaamheid van infliximab herbehandeling in de antimetabolieten groep te beoordelen. Om te beoordelen: veiligheid, de gezondheidsgerelateerde kwaliteit van leven, directe/ indirecte kosten, het beloop van bloed-CRP en fecaal calprotectine. Om het beloop van de dalconcentraties van infliximab en ATI in de 2 geplande onderhoudsgroepen van infliximab te beoordelen. Om correlaties tussen een reeks biomarkers en verschillende klinische en biologische uitkomsten te beoordelen. Om de impact van 6TGN-niveau op klinische en biologische uitkomsten in de met purine behandelde patiënten te beoordelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of Crohn’s disease.
    • Male or female, age > 18 years.
    • Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn’s disease.
    • Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.
    • Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.
    • Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose (lower dose than standard dose is also allowed if 6 TGN > 235 pmol) ; at least 15 mg/week subcutaneously for methotrexate.
    • Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients’ files.
    • CDAI < 150 at baseline.
    • A contraceptive during the whole study for childbearing potential female patients.
    • Patients able to understand the information provided to them and to give written informed consent for the study
    - Diagnose Morbus Crohn
    - Mannen en vrouwen, leeftijd > 18 jaar
    - Huidige behandeling met combinatietherapie met infliximab en anti-metabolitieten
    - combinatie therapie met infliximab en anti-metabolitieten gedurende tenminste 8 maanden
    - Geplande toediening van infliximab 5 mg/kg om de 8 weken gedurende de laatste 4 maanden.
    - Antimetabolieten behandeling met een stabiele dosering gedurende de laatste 3 maanden: ten minste 1 mg/kg of 2 mg kg voor respectievelijk mercaptopurine en azathioprine, of de hoogst getolereerde dosering indien intolerantie voor de standaarddosis (lagere dosering dan de standaarddosis is ook toegestaan) indien 6 TGN> 235 pmol); ten minste 15 mg week subcutaan voor methotrexaat.
    - Patiënten met steroïdenvrije klinische remissie gedurende ten minste 6 maanden volgens retrospectieve beoordeling van de patiëntenbestanden.
    • CDAI <150 bij baseline.
    • Een anticonceptiemiddel gedurende de hele studie voor vruchtbare potentiële vrouwelijke patiënten.
    • Patiënten die de aan hen verstrekte informatie begrijpen en schriftelijke toestemming voor het onderzoek geven
    E.4Principal exclusion criteria
    • Patients who have presented a severe acute or delayed reaction to infliximab.
    • Perianal fistulae as the main indication for infliximab treatment
    • Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
    • Patients with ostomy or ileoanal pouch
    • Pregnancy or planned pregnancy during the study
    • Inability to follow study procedures as judged by the investigator
    • Non-compliant subjects.
    • Participation in another therapeutic study
    • Steroid use ≤6 months prior to screening
    • Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide
    • Patiënten die een ernstige acute of vertraagde reactie op infliximab hebben gekregen.
    • Perianale fistels als de belangrijkste indicatie voor behandeling met infliximab
    • Actieve perianale / abdominale fistels op het moment van inclusie, gedefinieerd door actieve drainage
    • Patiënten met een stoma of een ileoanal pouch
    • Zwangerschap of geplande zwangerschap tijdens de studie
    • Onvermogen om onderzoeksprocedures te volgen zoals beoordeeld door de onderzoeker
    • Deelname aan een andere therapeutische studie
    • Gebruik steroïden ≤6 maanden voorafgaand aan screening
    • Momenteel gebruik van steroïden, immunosuppressiva (andere dan purine, methotrexaat), biologicals (anders dan infliximab) of thalidomide
    E.5 End points
    E.5.1Primary end point(s)
    There will be two co-primary efficacy end points
    Relapse rate at 2 years, relapse being defined by either one of the following events:
    - A CDAI≥250 at any visit or between 150 and 250 with an increase of at least 70 points, over two consecutive visits one week apart. This must be associated with a CRP > 5 mg/l or a fecal calprotectin > 250 microg/g
    - A new opening fistula, perianal or entero-cutaneous
    - An intra-abdominal abscess (size of at least 3 cm) or perianal abscess (size of at least 2 cm) (also considered as treatment failure, see below)
    - An episode of intestinal obstruction due to Crohn’s lesions confirmed by medical imaging and requiring hospitalisation (also considered as treatment failure, see below)

    Mean restricted time spent in remission
    This time will be computed in all patients, from baseline (CDAI <150 and with absence of fistula drainage) until relapse, as defined above, within the 2 first years. First and subsequent remissions (under the predefined treatment strategy according to randomization) will be summed up within the first two years.
    Er zijn twee co-primaire eindpunten voor werkzaamheid
    Terugvalpercentage na 2 jaar, terugval wordt bepaald door een van de volgende gebeurtenissen:
    - Een CDAI≥250 bij elk bezoek of tussen 150 en 250 met een toename van ten minste 70 punten, gedurende twee opeenvolgende bezoeken met een tussenpoos van een week. Dit moet in verband worden gebracht met een CRP> 5 mg/l of een fecaal calprotectine> 250 microgram/g
    - Een nieuwe fistelopening, perianaal of entero-cutaan
    - Een intra-abdominaal abces (grootte van ten minste 3 cm) of perianaal abces (grootte van ten minste 2 cm) (ook beschouwd als mislukte behandeling, zie hieronder)
    - Een episode van darmobstructie door Crohn's laesies bevestigd door medische beeldvorming en waarvoor ziekenhuisopname is vereist (ook beschouwd als mislukte behandeling, zie hieronder)

    Gemiddelde beperkte tijd doorgebracht in remissie
    Deze tijd zal worden berekend bij alle patiënten, vanaf baseline (CDAI <150 en met afwezigheid van fistel drainage) tot terugval, zoals hierboven gedefinieerd, binnen de 2 eerste jaren. Eerste en volgende remissies (onder de vooraf gedefinieerde behandelingsstrategie volgens randomisatie) worden in de eerste twee jaar samengevat.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 jaar
    E.5.2Secondary end point(s)
    - Time to relapse in each arm.
    - Factors associated with time to relapse.
    - Time to relapse according to CRP and calprotectin value measured every 2 months over the follow up.
    - Sustained clinical remission defined by CDAI<150 without steroids over two years.
    - Treatment failure rate. Treatment failure is defined by not achieving remission after treatment adaptation following a relapse according to protocol (CDAI<150 or, in case of relapse defined by the occurrence of a new fistula, the absence of fistula closure, defined clinically by the persistence of an opened fistulous track and/or drainage upon gentle pressure). Treatment failure will also be defined by a major treatment side-effect leading to treatment cessation. The occurrence of an intra-abdominal or perianal abscess and the occurrence of an intestinal obstruction due to Crohn’s lesions and requiring a surgical resection or an endoscopic dilatation are also directly considered as treatment failure and will not be managed by treatment adaptation according to protocol.
    - Time to treatment failure.
    - Incidence and severity of acute or delayed infliximab infusion reaction. Severity of the acute infusion reaction wil be assessed according to Ring et Messmer classification (6).
    - Tissue damage progression will be assessed by the Lémann Score absolute and relative change between baseline and end of the study (2 years).
    - Other secondary judgement criteria: CDEIS/SES-CD, MaRIA score, CDMRIS, disability index, adverse events and SAE, events related to re-infusions, trough levels of infliximab, ATI, hsCRP, fecal calprotectin, direct medical costs, work productivity and activity index, short health scale, EQ-5D. 
    - Tijd tot terugval in elke arm.
    - Factoren die verband houden met de tijd tot terugval.
    - Tijd tot terugval volgens CRP en calprotectine waarde gemeten elke 2 maanden gedurende de follow-up.
    - Aanhoudende klinische remissie gedefinieerd door CDAI <150 zonder steroïden gedurende twee jaar.
    - Faalpercentage behandeling. Falen van de behandeling wordt gedefinieerd door het niet bereiken van remissie na aanpassing van de behandeling na een terugval volgens protocol (CDAI <150 of, in geval van een recidief gedefinieerd door het ontstaan van een nieuwe fistel, de afwezigheid van fistelsluiting, klinisch gedefinieerd door de persistentie van een geopende fistelgang en/of drainage bij zachte druk.
    Falen van de behandeling zal ook worden gedefinieerd door een belangrijk bijwerking van de behandeling dat leidt tot beëindiging van de behandeling. Het ontstaan van een intra-abdominaal of perianaal abces en het ontstaan van een darmobstructie als gevolg van de laesies van Crohn waarvoor een chirurgische resectie of een endoscopische dilatatie nodig is, worden ook direct als falen van de behandeling beschouwd en zullen niet worden behandeld door aanpassing van de medicatie volgens protocol.
    - Tijd tot falen van de behandeling.
    - Incidentie en ernst van de acute of vertraagde infusie-reactie met infliximab. De ernst van de acute infusiereactie zal worden beoordeeld volgens de Ring et Messmer-classificatie (6).
    - Weefselschade progressie zal worden beoordeeld door de Lémann Score absolute en relatieve verandering tussen baseline en einde van de studie (2 jaar).
    - Andere secundaire beoordelingscriteria: CDEIS / SES-CD, MaRIA-score, CDMRIS, invaliditeitsindex, bijwerkingen en SAE, gebeurtenissen in verband met re-infusies, dalspiegels van infliximab, ATI, hsCRP, fecaal calprotectine, directe medische kosten, arbeidsproductiviteit en activiteit index, korte gezondheidsschaal, EQ-5D.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 jaar
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient report outcomes
    Patiënten vragenlijsten
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned70
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Netherlands
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    Last visit last patient
    laatste bezoek laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 300
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 300
    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)
    normal treatment of that condition
    Reguliere behandeling voor M. Crohn.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation INSERM
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA