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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2021-005309-28
    Sponsor's Protocol Code Number:APHP200031
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-005309-28
    A.3Full title of the trial
    Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial - CERTIFY
    Efficacité du certolizumab dans les échecs d’implantation répétés inexpliqués : essai contrôlé randomisé en double aveugle - CERTIFY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of certolizumab in women with unexplained recurrent implantation failure
    Efficacité du certolizumab chez les femmes présentant un échec d'implantation à répétition inexpliqué
    A.3.2Name or abbreviated title of the trial where available
    CERTIFY
    CERTIFY
    A.4.1Sponsor's protocol code numberAPHP200031
    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 SponsorAssistance Publique des Hôpitaux de Paris
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique des Hôpitaux de Paris
    B.5.2Functional name of contact pointRiad BAAMEUR
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux - DRCI - Hôpital Saint Louis
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number00330140275573
    B.5.5Fax number00330144891701
    B.5.6E-mailriad.baameur@aphp.fr
    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 CIMZIA® 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma S.A
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCIMZIA 200 mg
    D.3.4Pharmaceutical form Solution 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 INNCertolizumab pegol
    D.3.9.1CAS number 428863-50-7
    D.3.9.4EV Substance CodeSUB25423
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult women with recurrent implantation failures
    Femmes adultes présentant des échecs d'implantation récurrents
    E.1.1.1Medical condition in easily understood language
    correct immunological abnormalities and increase the pregnancy rate
    corriger les anomalies immunologiques et augmenter le taux de grossesse
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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 evaluate the efficacy of certolizumab compared to placebo on clinical pregnancy rate in women with unexplained recurrent implantation failure.
    évaluer l'efficacité du certolizumab par rapport au placebo sur le taux de grossesse clinique chez les femmes présentant un échec d'implantation récurrent inexpliqué
    E.2.2Secondary objectives of the trial
    1) To evaluate the efficacy of certolizumab compared to placebo in women with unexplained recurrent implantation failure in terms of:
    - live-birth rate
    - miscarriage rate
    2) To evaluate the safety of certolizumab in women with unexplained recurrent implantation failure
    1) Évaluer l'efficacité du certolizumab par rapport au placebo chez les femmes présentant un échec d'implantation récurrent inexpliqué en termes de:
    - taux de grossesses menées à terme
    - taux de fausses couches
    2) Évaluer l'innocuité du certolizumab chez les femmes présentant un échec d'implantation récurrent inexpliqué
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women aged 18-40 years
    - Idiopathic, male or tubal factor infertility
    - Unexplained recurrent implantation failure defined as consecutive failure to obtain clinical pregnancy after at least transfers of 3 good-quality embryos (Istanbul criteria)
    - Affiliation to a French social security system (beneficiary or legal)
    - Informed and signed consent
    - Femmes âgées de 18 à 40 ans
    - Infertilité idiopathique, masculine ou tubaire
    - Échec d’implantation récurent inexpliqué défini comme des échecs consécutifs inexpliqués à l'obtention d'une grossesse clinique après au moins 3 transferts de embryons de bonne qualité (critères d'Istanbul)
    - Affiliation à un système de sécurité sociale français (bénéficiaire ou légal)
    - Consentement éclairé et signé
    E.4Principal exclusion criteria
    Known cause of RIF among the following:
    - Genetic parental anomalies
    - Non-gestational diabetes mellitus of type I and II,
    - Infectious disease
    - Antiphospholipid syndrome
    - Sickle cell disease
    - Diffuse adenomyosis
    - No contraindication to Freeze-thaw embryo transfer (FET) treatment
    Linked to certolizumab:
    - Hypersensitivity to the active substances or to any of the excipients
    - Primary or secondary immunodeficiency (history of or currently active)
    - Active uncontrolled infection
    - Cardiac insufficiency (moderate to severe, NYHA III/IV classes)
    - Any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin
    - Immunization with a live/ attenuated vaccine within 4 weeks prior to baseline or simultaneously with treatment
    - Cytopenia as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), lymphocyte count < 0.5 × 109/L (500/mm3)
    - Liver cytolysis (AST / ALT > 5 N)
    - Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
    - Demyelinating neurological disease
    Linked to rifampicin and isoniazid (RIFINAH®)
    - Hypersensitivity to the active substances or to any of the excipients
    - Porphyria
    - Decreased blood-clotting from low vitamin K
    - Liver cytolysis (AST / ALT >5 N)
    - Combination with bictegravir, cobicistat, daclatasvir, dasabuvir, delamanid, grazoprevir / elbasvir, protease inhibitors boosted by ritonavir, isavuconazole, ledipasvir, lurasidone, midostaurine, ombitasvir / paritaprévir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprevir
    - Acute hepatitis, hepatic failure or chronic hepatic
    disease
    - Acute nephropathy
    Contraindication to anti-pneumoccal vaccination (Pneumovax®)
    - Hypersensitivity to the active substances or to any of
    Cause connue de RIF parmi les suivantes:
    - Anomalies génétiques parentales
    - Diabète sucré non gestationnel de type I et II,
    - Maladie infectieuse
    - Syndrome des anti-phospholipides
    - Drépanocytose
    - Adénomyose étendue
    Absence de contre-indications au traitement de transfert d'embryons par congélation-décongélation (FET)
    Lié au certolizumab:
    - Hypersensibilité aux substances actives ou à l'un des excipients
    - Immunodéficience primaire ou secondaire (antécédents ou actuellement actif)
    - Infection active non contrôlée
    - Insuffisance cardiaque (modérée à sévère, classes NYHA III/IV)
    - Toute tumeur maligne à l'exception du carcinome basocellulaire ou épidermoïde correctement traité
    - vaccination avec un vaccin vivant/ atténué dans les 4 semaines précédant la baseline ou pendant la période de traitement
    - Cytopénie définie par une numération plaquettaire <100 × 109/ L (100 000 / mm3), hémoglobine < 85 g / L (8,5 g / dL; 5,3 mmol / L), nombre absolu de neutrophiles < 2,0 × 109 / L (2000 / mm3), nombre de lymphocytes < 0,5 × 109 / L (500 / mm3)
    - Cytolise hépatique (AST / ALT > 5 N)
    - Insuffisance rénale, telle que définie par :créatinine >3 mg/dL ou une clairance de créatinine ≤ 20 ml/min
    - Maladie neurologique démyélinisante
    Lié à la rifampicine et à l'isoniazide (RIFINAH®)
    - Hypersensibilité aux substances actives ou à l'un des excipients
    - Porphyrie
    - Diminution de la coagulation sanguine due à un faible taux de vitamine K
    - Cytolise hépatique (AST / ALT > 5 N)
    - Association avec bictégravir, cobicistat, daclatasvir, dasabuvir, delamanide, grazoprévir/elbasvir, inhibiteurs de protéase boostés par le ritonavir, isavuconazole, lédipasvir, lurasidone, midostaurine, ombitasvir/paritaprévir, praziquantel, rilpivirine, sofosbuvir, velpatasvir, voriconazole, voxilaprévir.
    - Hépatite aiguë, insuffisance hépatique ou maladie hépatique chronique
    - Néphropathie aiguë
    Lié à la vaccination anti-pneumococcique (Pneumovax®)
    - Hypersensibilité aux substances actives ou à l'un des excipients
    E.5 End points
    E.5.1Primary end point(s)
    Clinical pregnancy defined as the presence of cardiac activity on ultrasound scan at 5 weeks +/- 6 days of gestation (post-implantation)
    grossesse clinique définie comme la présence d'une activité cardiaque à l'échographie à 5 semaines + 6 jours de gestation (post-implantation)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 5 weeks +/- 6 days of gestation (post-implantation)
    à 5 semaines + 6 jours de gestation (post-implantation)
    E.5.2Secondary end point(s)
    - Live-birth
    - Miscarriage defined as spontaneous abortion or pregnancy stop before 12 weeks of gestation (post-implantation)
    - All adverse events distinguishing serious adverse events. We will particularly evaluate:
    o multiple pregnancies
    o ectopic pregnancy
    o fetal abnormalities
    o small for gestational age
    o intrauterine growth restriction
    o preeclampsia
    - grossesse menée à terme - Fausse couche définie comme un avortement spontané avant 12 semaines de gestation (post-implantation)

    - Tous les événements indésirables distinguant les événements indésirables graves. Nous évaluerons notamment:
    * grossesses multiples
    * grossesse extra-utérine
    * anomalies fœtales
    * petite taille pour l'âge gestationnel
    * retard de croissance intra-utérin
    * pré-éclampsie
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks of gestation (post-implantation)
    2 semaines de gestation (post-implantation)
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned4
    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 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 of the last subject (LVLS)
    Dernier suivi du dernier 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 months4
    E.8.9.1In the Member State concerned days21
    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: 161
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state161
    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)
    None
    Aucun
    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 Decision2023-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-02
    P. End of Trial
    P.End of Trial StatusOngoing
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