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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44156   clinical trials with a EudraCT protocol, of which   7326   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2016-002061-54
    Sponsor's Protocol Code Number:Re-IMPROVE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002061-54
    A.3Full title of the trial
    "Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.
    Evaluation of immunogenicity and clinical response"
    “Switch tra Infliximab originator (Remicade®) ed Infliximab biosimilare (Remsima®) nel trattamento dell’artrite reumatoide, delle spondiloartriti e delle malattie infiammatorie croniche dell’intestino.
    Valutazione dell’immunogenicità e della risposta clinica”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.
    Switch tra Infliximab originator (Remicade®) ed Infliximab biosimilare (Remsima®) nel trattamento dell’artrite reumatoide, delle spondiloartriti e delle malattie infiammatorie croniche dell’intestino.
    A.3.2Name or abbreviated title of the trial where available
    Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)
    “Switch tra Infliximab originator (Remicade®) ed Infliximab biosimilare (Remsima®)
    A.4.1Sponsor's protocol code numberRe-IMPROVE
    A.5.4Other Identifiers
    Name:Re-IMPROVENumber:Re-IMPROVE
    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 SponsorUNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI
    B.1.3.4CountryItaly
    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 supportCelltrion Healthcare Co. Ltd
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Policlinico Universitario "A. Gemelli"
    B.5.2Functional name of contact pointU.O. Complessa di Reumatologia - Un
    B.5.3 Address:
    B.5.3.1Street AddressVia Giuseppe Moscati, 31
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0635034654
    B.5.5Fax number0635034523
    B.5.6E-mailreumatologia@rm.unicatt.it
    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 REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderCELLTRION HEALTHCARE HUNGARY KFT
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRemsima
    D.3.2Product code 42942019
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeBiosimilare
    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, seronegative spondylo arthritis,
    Crohn's Disease, Ulcerative Colitis
    Artrite Reumatoide, Spondiloartrite sieronegativa, Morbo di Crohn, Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis, seronegative spondylo arthritis,
    Crohn's Disease, Ulcerative Colitis
    Artrite Reumatoide, Spondiloartrite sieronegativa,
    Morbo di Crohn, Colite Ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075634
    E.1.2Term Acute haemorrhagic ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 demonstrate that the switch from Infliximab RMP (Remicade®) to Infliximab biosimilar (Remsima®), in patients who consent their study participation, does not determine, after 40 weeks of treatment (T3), an increase of the percentage of patients ADA positive≥ 20% in comparison with that measured at T0.
    Dimostrare che lo switch da Infliximab RMP (Remicade®) ad Infliximab biosimilare (Remsima®), nei pazienti che accettano di partecipare allo studio, non determina dopo 40 settimane di trattamento (T3) un incremento nella percentuale di pazienti ADA positivi superiore al 20% rispetto alla stessa percentuale rilevata al T0.
    E.2.2Secondary objectives of the trial
    The following subpopulations are defined: RA+AS for rheumatic disease, CD+UC for bowel disease.
    The objectives are:
    To assess the rate of change in the proportion of patients ADA+ before vs after the switch in subpopulations and in the overall study population.
    To assess for each pathology the therapeutic equivalence of Infliximab RMP and Infliximab biosimilar, through Clinical Indices and laboratory parameters measured at T-1 and T0 and after the switch at T1, T2 and T3 .
    To assess the equivalence of sieric level of ADAs at T0 and T3, in subpopulations and in the overall study population.
    To assess the equivalence of sieric level of Infliximab among values measured before vs after the switch.
    To assess the safety and tolerability of Infiximab biosimilar with respect to rate of AE and changes in vital signs and hematochemical parameters in subpopulations and in the overall study population.
    Si definiscono le seguenti sottopopolazioni: AR+AS per patologia reumatica, MC+CU per patologie intestinali.
    Gli obiettivi sono:
    Valutare nella popolazione globale di studio e nelle sottopopolazioni la variazione nella percentuale di pazienti ADA+ prime e dopo lo switch.
    Valutare per singola patologia l’equivalenza terapeutica di Infliximab RMP e Infliximab biosimilare, mediante indici clinici e parametri di laboratorio specifici per patologia, a T-1 e T0 e ai tempi T1, T2 e T3, dopo lo switch.
    Valutare, nella popolazione globale e nelle sottopopolazioni, la sostanziale equivalenza del livello sierico di ADAs a T0 e T3.
    Valutare, nella popolazione globale e nelle sottopopolazioni, la sostanziale equivalenza dei livelli sierici di Infliximab.
    Valutare, nella popolazione globale e nelle sottopopolazioni, la sicurezza e tollerabilità dell’Infliximab biosimilare in termini di incidenza di EA e andamento dei segni vitali e parametri ematochimici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age ≥18 years
    2. diagnosis of
    a. Rheumatoid Arthritis according to ACR criteria (1987 e 2010) OR
    b. Sieronegative spondiloarthritis (Ankylosing Spondylitis or Sponsiloarthritis (Psoriasic Arthritis) according to ASAS criteria 2009 OR
    c. Inflammatory Disease confirmed by endoscopic and histological criteria
    3. Treatment with Infliximab RMP (Remicade®) for at least 6 months with stable dosage at least in the last two infusions.
    4. Stable clinical response at the time of inclusion in the study (T-1) [stability is defined as reduction ≥30% of the disease activity scores in comparison with the start of treatment with Infliximab RMP (Remicade®)]
    5. In case of concomitant therapy with immunosuppressive drugs (azatioprine/6 mercaptopurine, methotrexate o leflunomide), their dosage should be stable at least in the last 2 months.
    6. In case of concomitant systemic therapy with steroids their dosage should be stable at least in the last 2 months and ≤7.5 mg/die of prednisone (or equivalent)
    7. Any concomitant drug for diseases other than those under study should be at a stable dosage for at least 4 weeks before the study inclusion.
    1. età≥18 anni
    2. pazienti con diagnosi di:
    a. Artrite Reumatoide secondo i criteri dell’ American College of Rheumatology (1987 e 2010)
    oppure
    b. Spondiloartrite sieronegativa (Spondilite anchilosante o Spondiloartrite/Artrite psoriasica) secondo i criteri ASAS 2009
    oppure
    c. IBD confermata da criteri endoscopici ed istologici
    3. pazienti in trattamento con Infliximab RMP (Remicade®) da almeno 6 mesi con dosaggio stabile almeno nelle ultime 2 infusioni
    4. pazienti con malattia in fase stabile di risposta clinica al momento dell’inclusione nel presente studio (T-1) [viene definita fase stabile una riduzione ≥30% degli score di attività di malattia rispetto all’inizio del trattamento con Infliximab RMP (Remicade®)]
    5. nel caso di pazienti in trattamento concomitante con farmaci immunosoppressori (azatioprina/6 mercaptopurina, metotrexato o leflunomide) questi farmaci devono essere a dosaggio stabile almeno negli ultimi 2 mesi
    6. nel caso di pazienti in trattamento con steroidi sistemici questi devono essere a dosaggio stabile almeno negli ultimi 2 mesi e ≤7.5 mg/die di prednisone (o equivalente)
    7. qualsiasi farmaco concomitante per patologie differenti da quelle in studio deve essere a dosaggio stabile da almeno 4 settimane prima dell’ingresso nello studio.
    E.4Principal exclusion criteria
    1. Active Infectious diseases
    2. Severe comorbidities (known malignancy except for basal cell carcinoma, congestive heart failure NYHA grade III/IV, liver and/or hepatobiliary disease, renal disease)
    3. Pregnancy or breast feeding
    4. Any underlying condition which, in the opinion of the Investigator, might contrarindicate the switch to Remsima®
    1. malattie infettive in fase attiva
    2. gravi co-morbidità (neoplasie con esclusione del carcinoma basocellulare cutaneo, insufficienza cardiaca congestizia di grado III/IV secondo la NYHA, malattie epatiche e/o epato-biliari, malattie renali)
    3. gravidanza o allattamento
    4. qualunque condizione che a giudizio del medico sperimentatore possa controindicare lo switch da infliximab a Remsima®.
    E.5 End points
    E.5.1Primary end point(s)
    Sieric level of Anti Drug Antibody measured by ELISA test (LISA-TRACKER Duo Infliximab).
    Per la determinazione quantitativa dei livelli sierici di ADAs sarà utilizzato un test immuno-enzimatico (ELISA) denominato LISA-TRACKER Duo Infliximab (Diametra, THERADIAG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    T0 (Switch) and T3
    T0 (Switch) e T3
    E.5.2Secondary end point(s)
    Indices of disease activity:
    Rheumatoid Arthritis: DAS 28 and CDAI; Spondyloarthritis: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS (Ankylosing Spondylitis Disease Activity Index), LEI (Leeds Enthesitis Index) and only for Psoriatic Arthritis DAPSA (Disease Activity Psoriatic Arthritis), PSAID12 (Psoriatic Arthritis Impact of Disease); Crohn’s Disease: HBI (Harvey Bradshow Index); Ulcerative Colitis pMAYO (partial MAYO).
    Indices of quality of life/functional status:
    Rheumatoid Arthritis: HAQ (Health Assessment Questionnaire); Spondyloarthritis: BASFI: (Bath Ankylosing Spondylitis Functional Index); Crohn’s Disease and Ulcerative Colitis: IBDQ (Inflammatory Bowel Disease Questionnaire).
    Sieric level of infliximab and Anti Drug Antibody measured by ELISA test (LISA-TRACKER Duo Infliximab).

    Ematochemical parameters (hemocrome + formula, ERS and CRP, GPT, GGT and GOT, ALP, creatinine only for patients with rheumatological diseases).
    Vital signs (blood pressure, body temperature, heart rate)
    Physical examination
    Adverse events
    Anti-Drug Antibodies
    Le variabili di efficacia sono rappresentate dagli indici di attività di malattia e di qualità della vita/stato funzionale specifici per la patologia di inclusione, livelli sierici di infliximab e ADAs.
    Indici di attività di malattia:
    1. Artrite reumatoide: DAS 28 e CDAI
    2. Spondiloartriti: BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS (Ankylosing Spondylitis Disease Activity Index), LEI (Leeds Enthesitis Index), e solo per pazienti con spondiloartrite psoriasica: DAPSA (Disease Activity Psoriatic Arthritis), PSAID12 (Psoriatic Arthritis Impact of Disease)
    3. Malattia di Crohn: HBI (Harvey Bradshow Index)
    4. Colite ulcerosa: pMAYO (partial MAYO)
    Indici di qualità della vita e stato funzionale:
    1. Artrite Reumatoide: HAQ (Health Assessment Questionnaire)
    2. Spondiloartriti: BASFI: (Bath Ankylosing Spondylitis Functional Index)
    3. Malattia Di Crohn e Colite Ulcerosa: IBDQ (Inflammatory Bowel Disease Questionnaire)
    Livelli sierici:
    Per la determinazione quantitativa dei livelli sierici di principio attivo e di ADAs sarà utilizzato un test immuno-enzimatico (ELISA) denominato LISA-TRACKER Duo Infliximab (Diametra, THERADIAG).

    La valutazione di sicurezza sarà effettuata attraverso esami ematochimici, rilevazione dei segni vitali e degli eventi avversi. Gli ADA oltre a rappresentare un parametro per la valutazione dell’efficacia (vedi sopra) rappresentano anche un parametro in termini di tollerabilità.
    1. Esami ematochimici : Emocromo con formula, VES e PCR, ALT, GGT saranno misurati in occasione di tutte le visite dello studio. In aggiunta, per i soli pazienti di Reumatologia, verranno misurati AST, Fosfatasi Alcalina, Creatinina
    2. Segni vitali: Pressione arteriosa, temperatura corporea e frequenza cardiaca misurate come da pratica clinica in occasione di tutte le visite dello studio
    3. esame obiettivo generale: anormalità alla visita di inclusione saranno registrate in anamnesi mentre quelle rilevate in corso di studio e non prima evidenziate saranno registrate come eventi avversi.
    4. eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    T-1, T0 (Switch), T1, T2 and T3
    T-1, T0 (Switch), T1, T2 e T3
    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 Yes
    E.6.13.1Other scope of the trial description
    Equivalence in terms of immunogenicity and clinical response in real world
    Equivalenza in termini di immunogenicità e risposta clinica in pratica clinica
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    cross over a singolo braccio
    single-arm cross over study
    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 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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 and the patient care will be according to the local clinical practice.
    Il trattamento e l'assistenza proseguiranno come per pratica clinica di ciascun centro.
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA