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    Summary
    EudraCT Number:2019-000717-37
    Sponsor's Protocol Code Number:AMGEVITA-HVM2019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-000717-37
    A.3Full title of the trial
    LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.
    "ADA-SWITCH Study"
    PÉRDIDA DE RESPUESTA DEL FÁRMACO BIOSIMILAR DE ADALIMUMAB COMPARADA CON LA PÉRDIDA DE RESPUESTA DEL FÁRMACO ORIGINAL: ESTUDIO CONTROLADO, RANDOMIZADO, DE NO INFERIORIDAD Y ABIERTO.
    “Estudio ADA-SWITCH”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Loss of response of the Adalimumba biosimilar compared with the original drug
    Perdida de respuesta del biosimilar de Adalimumab comparada con el medicamento original
    A.3.2Name or abbreviated title of the trial where available
    ADA-SWITCH Study
    Estudio ADA-SWITCH
    A.4.1Sponsor's protocol code numberAMGEVITA-HVM2019
    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 SponsorFundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)
    B.1.3.4CountrySpain
    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 supportown funding
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y Ensayos Clínicos
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Manuel Siurot S/N
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955012144
    B.5.5Fax number0034955095338
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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 AMGEVITA®
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAMGEVITA (Adalimumab biosimilar )
    D.3.4Pharmaceutical form Solution for injection
    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 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 HUMIRA ®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHumira (adalimumab original)
    D.3.4Pharmaceutical form Solution for injection
    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 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.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
    Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis
    Enfermedad Inflamatoria intestinal: Enfermedad de Crohn y Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Disease
    Enfermedad Inflamatoria intestinal
    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 compare the loss of response of the switch (replacement) from Adalimumab original (Humira®) to Adalimumab biosimilar (Amgevita®) vs the maintenance of the Adalimumab original in patients with inflammatory bowel disease.
    Comparar la pérdida de respuesta del switch (sustitución) de Adalimumab original (Humira®) por Adalimumab biosimilar (Amgevita®) vs el mantenimiento del medicamento original en pacientes con enfermedad inflamatoria intestinal.
    E.2.2Secondary objectives of the trial
    - Compare the safety of the Adalimumab original switch (Humira®) to Adalimumab biosimilar (Amgevita®) vs the maintenance of the original medication in patients with inflammatory bowel disease.
    - Compare the antibody formation rate with Adalimumab(immunogenicity) after the switch.
    - Compare the score of the specific quality of life questionnaire in patients with inflammatory bowel disease (IBDQ-9) before and after the switch.
    - Compare the score of the visual analogue scale (VAS) of pain at the puncture site after the switch.
    - Determine prognostic factors for the maintenance of biochemical remission (C-reactive protein, calprotectin), and drug (drug levels, formation of antibodies against ADA drug).
    Comparar la seguridad del switch de Adalimumab original (Humira®) a Adalimumab biosimilar (Amgevita®) vs el mantenimiento del medicamento original en pacientes con enfermedad inflamatoria intestinal.
    Comparar la tasa de formación de anticuerpos contra el fármaco (inmunogenicidad) tras el switch.
    Comparar la puntuación del cuestionario de calidad de vida específico en pacientes con enfermedad inflamatoria intestinal (IBDQ-9) antes y después del switch.
    Comparar la puntuación de la escala análoga visual (EVA) de dolor en el sitio de punción tras el switch.
    Determinar factores pronósticos para el mantenimiento de la remisión bioquímicos (PCR, calprotectina), como del medicamento (niveles de fármaco, formación de anticuerpos contra fármaco ADA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Be male or female over 18 years of age
    - Be a Patient with a previous confirmed diagnosis of Crohn´s disease an Ulcerative Colitis
    - Previous treated with original Adalimumab for at least 6 months with regular maintenance dose (40 mg every 15 days) and in clinical and biological remission.
    - Patients under treatment with intensified Adalimumab (40mg every 7 days or 80mg every 7 days) to maintain clinical and biological remission for at least 6 months.
    - Patients with oral mesalazine with a stable dose for more than 30 days.
    - Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time> 60 days.
    - Patients may be accepted with corticosteroids at the established doses: prednisone <20mg / dl, budesonide <9mg / dl.
    - Patients who have a tuberculosis (TB) study (Mantoux / QuantiFERON-TB test) updated in the last two year, with a negative result.
    - Patient with serology hepatitis B and C, updated at the begining of the treatment with Humira®
    - Sign an informed consent document indicating that he/she understands the purpose of, and procedures required for, the study and are willing to participate in the study.
    - Hombre o mujeres mayores de 18 años
    - Paciente con diagnostico confirmado de Enfermedad de Crohn y Colitis Ulcerosa
    - Tratamiento previo con Adalimumab original durante al menos 6 meses con dosis regular de mantenimiento (40 mg cada 15 días) y que se encuentren en remisión clínica y biológica.
    -Pacientes en tratamiento con Adalimumab intensificado (40mg cada 7 días u 80mg cada 7 días) que se mantengan remisión clínica y biológica por al menos 6 meses. -
    -Pacientes con mesalazina oral con dosis estables por más de 30 días.
    -Pacientes con terapia inmunosupresora (metotrexato, azatioprina) con un mínimo de tiempo de toma > 60 días.
    - Se podrá incluir pacientes con toma de corticoides a las dosis establecidas: prednisona < 20mg/dl, budesónida <9mg/dl.
    - Pacientes que tenga estudio de Tuberculosis (TBC) (Mantoux/quantiferon) actualizado en el último año, con resultado negativo.
    - Paciente con serología hepatitis B y C actualizada al inicio del tratamiento con Humira®
    - Firma de consentimiento informado indicando el proposito del estudio, los procedimientos a efectuarse, y la aceptación de participación.
    E.4Principal exclusion criteria
    -Pregnant or nursing women
    - Patients with uncontrolled comorbidities, active cancer, diabetes mellitus, severe cardiovascular disease, obstructive pulmonary disease, serious active infections.
    - Patients with oral mesalazine initiated less than 30 days.
    - Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time of <60 days.
    - Patient with original Adalimumab who do not meet a minimum of 6 months of stable dose (40 mg every 7 or 15 days)
    - Patient on corticosteroid therapy at doses: prednisone> 20mg / dl, budesonide = 9mg / dl, or with IV corticoids within 14 days prior screening date.
    - Patients with mental disorders, alcohol / other substance abuse, or conditions that do not allow adherence to the study protocol.
    - Patients with active TB
    - Patients with defined Hepatitis B and C defined as:
    HBV: hepatitis B surface antigen (HbsAg) positive together with positive HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR).
    HCV: HCV ribonucleic acid (RNA) detectable in any patient with positive anti-HCV antibody (IgG)
    -Mujeres embarazadas o en lactancia
    -Pacientes con comorbilidades no controladas, cáncer activo, diabetes mellitus, Enfermedad cardiovascular severa, enfermedad pulmonar obstructiva, infecciones graves activas.
    -Pacientes con mesalazina oral iniciada en menos de 30 días.
    -Pacientes con terapia inmunosupresora (metotrexato, azatioprina) con un mínimo de tiempo de toma < 60 días.
    -Paciente con Adalimumab original que no cumplan mínimo 6 meses de dosis estable (40 mg cada 7 o 15 días)
    -Paciente en terapia con corticoides a dosis: prednisona > 20mg/dl, budesónida = 9mg/dl, o con corticoides intravenosos durante los 14 días previos a la fecha de selección-
    -Pacientes con trastornos mentales, abuso de alcohol/otras sustancias, u condiciones que no permitan la adherencia al protocolo de estudio.
    -Pacientes con TBC activa
    -Pacientes con Hepatitis B y C definido:
    VHB: Hepatitis B antígeno de superficie positivo (HbsAg+) junto con DNA VHB positivo.
    VHC: RNA detectable con IgG positivo;
    E.5 End points
    E.5.1Primary end point(s)
    Loss of response: measured as the proportion of patients with a loss of response at twelve months (adalimumab original vs adalimumab biosimilar)
    Pérdida de respuesta: medida como la proporción de pacientes con pérdida de respuesta durante los doce meses en cada grupo (adalimumab original vs adalimumab biosimilar)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-months
    Doce meses
    E.5.2Secondary end point(s)
    Loss of response:
    - Proportion of patients who need treatment intensification
    - Proportion of patients who need corticosteroids
    - Proportion of patients who need to change biological due to loss of response
    - Proportion of patients with changes in the quality of life index (IBDQ-9) after the switch.
    - Proportion of patients presenting a higher score on the analogous scale of pain after the drug switch.

    Immunogenicity
    Immunogenicity rate: measured as the proportion of patients that generate anti- drug antibodies after the switch

    Safety
    - Rate of adverse events: measured as the proportion of adverse events during the clinical study. (all types of adverse events will be reported, and they will be graduated according to their severity and will collected in CRF)
    - Hospital admission rate measured as the proportion of patients requiring hospital admissions related to a disease outbreak during follow-up.
    - Surgery rate: measured as the proportion of patients requiring surgery related to disease activity during follow-up.
    Perdida de respuesta:
    Proporción de pacientes que necesitan intensificación de tratamiento
    Proporción de pacientes que necesitan la toma de corticoides
    Proporción de pacientes que necesitan cambiar de biológico por perdida de respuesta
    Proporción de pacientes con cambios en la encuesta de calidad de vida (IBDQ-9) tras la sustitución del medicamento.
    Proporción de pacientes que presentan puntuación elevada en la escala análoga del dolor tras la sustitución del fármaco.

    Inmunogenicidad:

    Tasa inmunogenicidad: medida como la proporción de pacientes que generan anticuerpos antifármaco tras el switch

    Seguridad :

    Tasa de acontecimientos adversos: medida como la proporción de eventos adversos durante el estudio clínico. (se reportarán todo tipo de eventos adversos que serán graduados según gravedad y anotados en CRD)
    Tasa de ingresos hospitalario medida como la proporción de pacientes que requieren ingresos hospitalarios relacionados con brote de la enfermedad durante el seguimiento.
    Tasa de cirugía: medida como la proporción de pacientes que requieren cirugía relacionada con actividad de la enfermedad durante el seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    loss of response : 12 months
    Safety : 16 months
    Perdida de respuesta: 12 meses
    Seguridad: 16 meses
    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 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) 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    A subject will be withdrawn from the study for any of the following reasons:
    The patient (or the subject´s representative) withdraws of consent for study participation
    The patient experiences serious adverse reactions related to the treatment during the follow-up
    The patient develops a malignancy including squamous cell skin cancer.
    Serious opportunistic infections occur
    Loss of follow-up
    Criterios de finalización o interrupción del estudio
    - El pacientes ( o su representante) retiren el consentimiento informado
    - Paciente presente eventos adversos serios durante el seguimiento
    - El pacientes desarrolle un tumor incluido cancer de piel
    - Infecciones oportunistas serias
    - Perdida del seguimiento
    - Perdida de eficacia
    - Pacientes que no cumplan adherencia al tto.
    - Autoadministración de corticoides orales o mesalazina.
    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 days
    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: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state136
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 136
    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 clinical study will be completed after 12 months of follow-up of the last patient included in the clinical study.

    After the study is considered complete, patients will continue with the same treatment in routine clinical practice.
    El ensayo clínico se completará después de 12 meses de seguimiento del ultimo paciente incluido.

    Después que el estudio termine, los pacientes continuaran con el mismo tratamiento en las consultas clínicas habituales.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation UICEC-HUVR
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-08
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