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    Summary
    EudraCT Number:2011-004468-31
    Sponsor's Protocol Code Number:CT-P13-3.2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-004468-31
    A.3Full title of the trial
    An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13-3.1
    Studio di estensione in aperto, a braccio singolo, per dimostrare l'efficacia e la sicurezza a lungo termine di CT-P13 somministrato con metotressato in pazienti con artrite reumatoide trattati con Infliximab (Remicade o CT-P13) nello studio CT-P13-3.1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis
    Comparazione degli effetti a lungo termine tra CT-P13 e Remicade somministrati in associazione con metotressato in pazienti con artrite
    A.4.1Sponsor's protocol code numberCT-P13-3.2
    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 SponsorCELLTRION, INC.
    B.1.3.4CountryKorea, Republic of
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCELLTRION, Inc
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCELLTRION, Inc
    B.5.2Functional name of contact pointHyuk Jae Lee
    B.5.3 Address:
    B.5.3.1Street Address13-6, Songdo-dong
    B.5.3.2Town/ cityYeonsu-gu / Incheon
    B.5.3.3Post code406-84
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+82 32 850-5394
    B.5.5Fax number+82 32 850-5060
    B.5.6E-mailHyukJae.Lee@celltrion.com
    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 nameCT-P13
    D.3.2Product code CT-P13
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.2Current sponsor codeCT-P13
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Rheumatoid Arthritis
    Artrite Reumatoide
    E.1.1.1Medical condition in easily understood language
    Arthritis
    Artrite
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm long-term efficacy and safety of CT-P13.
    Confermare l’efficacia e la sicurezza a lungo termine di CT-P13.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Patient who has completed the scheduled visits, including the End-of- Study Visit, in Study CT-P13 3.1. 2 Patient who has not had any major protocol violation in Study CT-P13 3.1. 3 Patient is permitted to enter the extension study if, in the opinion of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed. 4 Patient (or legal guardians, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, and has signed and dated the written informed consent before inclusion in the extension study. 5 Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study and for 6 months following discontinuation of study treatment (excluding women who are not of childbearing potential and men who have been sterilized).6 Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 2 medically accepted methods of contraception as per inclusion criterion 5. 7 Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
    1.Il paziente che ha completato tutte le visite previste, compresa la visita di fine studio, dello Studio CT-P13 3.1. 2.Il paziente che non ha avuto alcuna grave violazione del protocollo dello Studio CT-P13 3.1. 3.Il paziente e’ ammesso alla partecipazione allo studio di estensione se, a giudizio del loro medico di base o dello Sperimentatore, continuera’ a trarre beneficio dal trattamento dello studio di estensione. Verranno adottate le linee guida locali per il trattamento del paziente. 4.Il paziente (o tutore legale, se applicabile) deve aver ricevuto informazioni sulla natura e sugli obiettivi dello studio, compreso i possibili rischi ed effetti collaterali, deve aver avuto sufficiente tempo e possibilità di leggere e comprendere queste informazioni e deve avere infine firmato e datato il consenso informato scritto, prima della sua ammissione allo studio di estensione. 5.I pazienti maschi e femmine e o rispettivi partner in età fertile dovranno accettare di utilizzare 2 metodi contraccettivi approvati a livello medico (ad es. metodi contraccettivi a barriera [profilattico maschile, profilattico femminile o diaframma con un gel spermicida], contraccettivi ormonali impianti, contraccettivi iniettabili, contraccettivi orali combinati, cerotti transdermici o anelli vaginali e dispositivi intrauterini) durante lo svolgimento dello studio e per 6 mesi dopo il termine del trattamento dello studio (ad esclusione delle donne non in età fertile e degli uomini che sono stati sterilizzati). 6.I pazienti maschi e femmine e i rispettivi partner che sono stati sottoposti a sterilizzazione chirurgica meno di 6 mesi prima dell’ingresso nello studio dovranno accettare di utilizzare 2 metodi contraccettivi approvati a livello medico come da criterio di inclusione n. 7. 7.Le donne in menopausa dovranno aver avuto il loro ultimo ciclo oltre 12 mesi prima dell’ingresso nello studio al fine di essere classificate come non in età fertile.
    E.4Principal exclusion criteria
    1 Patient who has been withdrawn from Study CT-P13 3.1 for any reason. 2 Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator. 3 Patient who plans to participate in a study with an investigational drug during the period of this extension study. 4 Female patient who is planning to become pregnant or breastfeed within the period of this study. 5 Patient who plans to receive a live or live-attenuated vaccination or who is scheduled to receive a live or live-attenuated vaccination during the period of this study. Killed vaccines are acceptable during the study. 6 Patient who, in the opinion of their general practitioner or investigator, should not participate in this extension study for whatever reason. 7 Patient who is receiving any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the time of providing informed consent or planned within 6 months after the time of providing informed consent. 8 Patient who, at the time of providing informed consent, is taking, is planning to take, or is required to take during the course of this study any of the following concomitant medications: • Corticosteroids, except oral glucocorticoids, of maximum equivalent daily dose of 10 mg of prednisolone. (Patients are permitted to receive low-potency topical, otic, and ophthalmic glucocorticoid preparations provided the preparations are administered per the instructions on the product label.) • Disease-modifying antirheumatic drugs, other than methotrexate, including hydroxychloroquine, chloroquine, sulfasalazine, or leflunomide. • Alkylating agents • Live or live-attenuated vaccines • Any biological agents for the treatment of RA except CT-P13 or Remicade
    1.Il paziente che ha interrotto la sua partecipazione allo Studio CT-P13 3.1, qualunque sia stato il motivo. 2.Il paziente che, all’atto della sottoscrizione del consenso informato, manifesta problemi medici quali eventi avversi gravi (SAE) o problemi di intolleranza, e la cui partecipazione allo studio di estensione potrebbe, a giudizio dello Sperimentatore, pregiudicare il suo stato di salute. 3.Il paziente che intende partecipare allo studio di un altro farmaco sperimentale condotto durante il periodo dello studio di estensione. 4.La paziente donna che intende iniziare una gravidanza o allattare al seno durante lo studio di estensione. 5.Il paziente che intende ricevere un vaccino vivo o vivo attenuato o che ha già programmato di ricevere un vaccino vivo o attenuato durante lo svolgimento dello studio di estensione. I vaccini inattivi sono ammessi durante lo svolgimento dello studio. 6.Il paziente che, a giudizio del medico di base o dello sperimentatore, non e’ idoneo a partecipare a questo studio di estensione, qualunque ne sia il motivo. 7.Il paziente che si sottopone a una procedura chirurgica, tra cui un intervento chirurgico diretto sulle ossa o sulle articolazioni o una sinovectomia (compreso la fusione o sostituzione dell’articolazione), nei 12 mesi precedenti alla sottoscrizione del consenso informato o la cui esecuzione è prevista entro 6 mesi dalla data di sottoscrizione del consenso informato. 8.Il paziente che, all’atto della sottoscrizione del consenso informato, sta assumendo, prevede di assumere o sara’ tenuto ad assumere nel corso dello studio uno o più dei seguenti farmaci concomitanti: •Corticosteroidi, ad eccezione dei glucocorticoidi orali, alla dose giornaliera massima equivalente a 10 mg di prednisolone. (Ai pazienti è consentito usare preparati glucocorticoidi, a basso potenziale, per uso topico, otico e oftalmico e purché i preparati vengano somministrati in conformità con le istruzioni riportate sull’etichetta del prodotto.) •Farmaci reumatici modificanti la malattia, diversi dal metotressato, compreso idrossiclorochina, clorochina, sulfasalazina o leflunomide. •Agenti alchilanti •Vaccini vivi o vivi attenuati •Qualsiasi agente biologico per il trattamento di AR ad eccezione di CT-P13 o Remicade
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoint evaluations are: • Individual components of the ACR criteria comparison with baseline of Study CT-P13 3.1 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102) • Mean decrease in disease activity measured by DAS28 comparison with baseline of Study CT-P13 3.1 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102) • Proportion of patients with a good response defined according to the EULAR response criteria at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102) • Proportion of patients achieving ACR20, ACR50, and ACR70 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102) • Hybrid ACR response at Weeks 78 and 102 (or the End-of-Study Visit ifnot obtained at Week 102) • Joint damage progression at Week 102 (or the End-of-Study Visit if not obtained at Week 102) • Number of patients requiring salvage retreatment at Week 102 (or the End-of-Study Visit if not obtained at Week 102) The safety endpoint evaluations are: • Immunogenicity at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102) • Vital sign measurements • ECG findings at Week 102 (or the End-of-Study Visit if not obtained at Week 102) • Interferon-γ release assay • Physical examination findings • Clinical laboratory tests including urine pregnancy, ESR, and CRP tests • AEs including SAEs • Concomitant medications • Signs and symptoms of TB • Infections • Infusion-related reactions • Malignancies
    Le valutazioni degli endpoint di efficacia sono: •Confronto dei singoli componenti dei criteri ACR con la baseline dello Studio CT-P13-3.1, alla Settimana 78 e 102 (o alla Visita di fine studio, se non rilevato alla Settimana 102) •Confronto della diminuzione media dell’attività della malattia misurata da DAS28 rispetto alla baseline dello Studio CT-P13 3.1, alla Settimana 78 e 102 (o alla Visita di fine studio, se non rilevata alla Settimana 102) •Percentuale di pazienti con una buona risposta definita in base ai criteri di risposta EULAR alla Settimana 78 e 102 (o alla Visita di fine studio se non rilevata alla Settimana 102) •Percentuale di pazienti con conseguimento di ACR20, ACR50 e ACR70 alla Settimana 78 e 102 (o alla Visita di fine studio se non rilevata alla Settimana 102) •Misura ibrida della risposta ACR alla Settimana 78 e 102 (o alla Visita di fine studio se non effettuata alla Settimana 102) •Progressione del danno alle articolazioni rilevata alla Settimana 102 (o alla Visita di fine studio se non rilevata alla Settimana 102) •Numero di pazienti che richiedono una terapia di salvataggio alla Settimana 102 (o alla Visita di fine studio se non rilevato alla Settimana 102). Le valutazioni degli endpoint di sicurezza sono: •Immunogenicità rilevata alla Settimana 78 e 102 (o alla Visita di fine studio se non effettuata alla Settimana 102) •Misurazione dei segni vitali •Valutazione ECG eseguita alla Settimana 102 (o alla Visita di fine studio se non eseguito alla Settimana 102) •Test di rilascio dell’interferone-y •Risultati dell'esame fisico •Test clinici di laboratorio compreso test di gravidanza, VES e CRP •EA compresi eventi avversi seri •Farmaci concomitanti •Segni e sintomi di TB •Infezioni •Reazioni legate all’infusione •Tumori maligni
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy will be evaulated at: week 78, 102 and 110. Safety will be evaulated at: week 62, 70, 78, 86, 94, 102 and 110
    L'efficacia verrà valutata alle settimane 78,102 e 110. La sicurezza verrà valutata alle settimane 62, 70, 78, 86, 94, 102 e 110.
    E.5.2Secondary end point(s)
    Not applicable
    Non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Non applicabile
    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 No
    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 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 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
    Bosnia and Herzegovina
    Chile
    Colombia
    Jordan
    Korea, Republic of
    Mexico
    Peru
    Philippines
    Ukraine
    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
    LVLS: The end of the study is defined as the date on which the last patient completes the last visit (includes End-of-Study Visit).
    LVLS: La fine dello studio è definita come la data in cui l'ultimo paziente completa l'ultima visita (compreso la Visita di fine studio).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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.1.1Number of subjects for this age range: 0
    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: 417
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 234
    F.4.2.2In the whole clinical trial 617
    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)
    Patients will transition to local standard of care treatment if required in the opinion of the investigator.
    I pazienti passeranno al trattamento standard per la patologia se considerato necessario dallo Sperimentatore.
    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 Decision2012-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
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