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    Summary
    EudraCT Number:2013-005001-31
    Sponsor's Protocol Code Number:CGV222
    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:2014-02-07
    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 number2013-005001-31
    A.3Full title of the trial
    Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity
    Ensayo clínico aleatorizado sobre la prevención de la progresión radiológica con ácido zoledrónico en pacientes con artritis reumatoide de inicio y baja actividad de la enfermedad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease.
    Estudio sobre la capacidad del ácido zoledrónico para prevenir el empeoramiento de las radiografías de manos y pies de los pacientes con artritis reumatoide diagnosticados hace menos de 2 años y que tienen pocos síntomas en sus articulaciones haciendo tratamiento con los medicamentos habitualmente utilizados para el tratamiento de la enfermedad.
    A.3.2Name or abbreviated title of the trial where available
    Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid
    Prevención de la progresión radiológica en la artritis reumatoide con ácido zoledrónico
    A.4.1Sponsor's protocol code numberCGV222
    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 SponsorDra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)
    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 supportMinisterio de Economía y Competitividad
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Bellvitge
    B.5.2Functional name of contact pointCarmen Gómez-Vaquero
    B.5.3 Address:
    B.5.3.1Street AddressFeixa Llarga s/n
    B.5.3.2Town/ cityL'Hospitalet
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number34932607712
    B.5.5Fax number34932607086
    B.5.6E-mailcarmen.gomez@bellvitgehospital.cat
    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 Zoledronic acid
    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 nameZoledronic acid
    D.3.4Pharmaceutical form Concentrate 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 INNZOLEDRONIC ACID
    D.3.9.1CAS number 118072-93-8
    D.3.9.4EV Substance CodeSUB00176MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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
    Rheumatoid arthritis
    Artritis reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis (Rheumatic disease characterized by swelling of many joints)
    Artritis reumatoide (Enfermedad reumatológica caracterizada por la hinchazón de muchas articulaciones)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 assess the progression of radiographic damage in patients with early RA in current treatment with DMARDs and low disease activity to which treatment with zoledronic acid is added, compared to a no treatment control population.
    Evaluar la progresión del daño radiológico en pacientes con AR de inicio en tratamiento habitual con FAME y baja actividad de la enfermedad a los que se añade tratamiento con ácido zoledrónico, respecto a una población control de no tratamiento.
    E.2.2Secondary objectives of the trial
    a. To assess the progression of radiological damage after one year
    b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years
    c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years
    d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years
    e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning.
    f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity.
    g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression.
    h. To study the safety of zoledronic acid.
    a. Evaluar la progresión del daño radiológico al año
    b. Comparar la pérdida de masa ósea periarticular mediante densitometría ósea DXA de manos a los 2 años
    c. Comparar la pérdida de masa ósea generalizada mediante densitometría ósea DXA de columna lumbar y fémur proximal a los 2 años
    d. Determinar la variación del tamaño de las erosiones de manos mediante tomografía computerizada de alta resolución (TAC), a los dos años
    e. Evaluar el valor predictivo de respuesta de los objetivos previos con las concentraciones séricas de OPG, RANKL, DKK-1 y esclerostina al inicio.
    f. Determinar la proporción de pacientes que acaban necesitando la adición de un tratamiento biológico por presentar actividad mantenida de la enfermedad.
    g. Determinar la proporción de pacientes que acaban necesitando la adición de un tratamiento biológico por presentar progresión radiológica.
    h. Estudiar la seguridad de ácido zoledrónico.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The objective of sub-study CT and DXA is to determine the size variation of carpal and metacarpophalangeal joints erosions and to compare the loss of periarticular bone mass of the hands and general bone loss of lumbar spine and proximal femur by high resolution computed tomography (CT) and DXA bone densitometry, respectively, at two years in a group of patients with rheumatoid arthritis of recent onset and low disease activity treated with zoledronic acid with respect to a group of No treatment.
    El objetivo del subestudio TAC y DXA es determinar la variación del tamaño de las erosiones de carpo y articulaciones metacarpofalángicas y la pérdida de masa ósea periarticular de manos y generalizada en columna lumbar y fémur proximal mediante tomografía computerizada y densitometría ósea DXA, respectivamente, a los dos años, en un grupo de pacientes con artritis reumatoide de inicio y baja actividad de la enfermedad tratados con ácido zoledrónico respecto al grupo de No tratamiento.
    E.3Principal inclusion criteria
    1. Age ? 18 years
    2. Patients with RA of less than 2 years of evolution
    3. DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
    4. Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
    5. Low disease activity (DAS28 <3.2)
    6. Im case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
    7. Signed informed consent
    1. Edad igual o superior a 18 años
    2. Pacientes afectos de AR de menos de 2 años de evolución
    3. Tratamiento con FAME (metotrexato en monoterapia o metotrexato-leflunomida o metotrexato en pauta COBRA) en dosis estable durante como mínimo las 6 semanas previas a la inclusión en el estudio
    4. Pacientes no tratados con glucocorticoides o en tratamiento estable con prednisona hasta 5 mg/día o dosis equivalente de otro glucocorticoide
    5. Baja actividad de la enfermedad (DAS28 < 3,2)
    6. En caso de mujeres premenopáusicas, compromiso de realizar tratamiento contraceptivo hasta 3 años después de la última dosis de ácido zoledrónico
    7. Firma del consentimiento informado
    E.4Principal exclusion criteria
    1. Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
    2. Pretreatment with:
    a. Bisphosphonates in the 5 years prior to the onset of RA
    b. Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
    3. Contraindication to treatment with zoledronic acid:
    a. Hypersensitivity to bisphosphonates
    b. Hypocalcemia
    c. Glomerular filtration rate <35 mL / min
    d. Pregnant (negative pregnancy test) and lactating women
    e. Poor oral hygiene
    f. Pending invasive dental procedure
    4. Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
    5. Simultaneous participation in another clinical trial
    1. Tratamiento previo o actual con fármacos biológicos utilizados como tratamiento de la AR (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
    2. Tratamiento previo con:
    a. Bisfosfonatos en los 5 años previos al inicio de la AR
    b. Calcitonina, raloxifeno, bazedoxifeno, ranelato de estroncio, teriparatida o denosumab en el año previo al inicio de la AR
    3. Contraindicación para recibir tratamiento con ácido zoledrónico:
    a. Hipersensibilidad a bisfosfonatos
    b. Hipocalcemia
    c. Filtrado glomerular < 35 mL/min
    d. Mujeres gestantes (test de embarazo negativo) y lactantes
    e. Mala higiene oral
    f. Procedimiento dental invasivo pendiente
    4. Concentración sérica de calcidiol inferior a 25 nmol/L (10 ng/mL).
    5. Participación simultánea en otro ensayo clínico
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the Sharp-van der Heijde index (SHI) in radiographs of hands and feet after two years.
    La variable de estudio principal es la progresión del daño radiológico evaluada de manera ciega por el incremento del índice de Sharp-van der Heijde (ISH), en radiografías de manos y pies, a los dos años.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after two years
    Basal y después de dos años.
    E.5.2Secondary end point(s)
    In patients with early RA in current treatment with DMARDs and low disease activity to whom zoledronic acid or no treatment is added:
    a. To assess the progression of radiological damage after one year
    b. To compare the loss of periarticular bone mass by DXA bone densitometry of the hands at two years
    c. To compare general bone loss by DXA bone densitometry of lumbar spine and proximal femur at two years
    d. To determine the size variation of carpal and metacarpophalangeal joints erosions by high resolution computed tomography (CT), at two years
    e. To assess the predictive value of response to previous targets of serum OPG, RANKL, DKK-1 and sclerostin assets at the beginning of the study treatments.
    f. To determine the proportion of patients that eventually require the addition of biological treatment for presenting sustained disease activity.
    g. To determine the proportion of patients that eventually require the addition of biological treatment for presenting radiological progression.
    h. To study the safety of zoledronic acid.
    En pacientes con AR de inicio en tratamiento habitual con FAME y baja actividad de la enfermedad a los que se añade o no tratamiento con ácido zoledrónico:
    a. Evaluar la progresión del daño radiológico al año
    b. Comparar la pérdida de masa ósea periarticular mediante densitometría ósea DXA de manos a los 2 años
    c. Comparar la pérdida de masa ósea generalizada mediante densitometría ósea DXA de columna lumbar y fémur proximal a los 2 años
    d. Determinar la variación del tamaño de las erosiones de carpo y articulaciones metacarpofalángicas mediante tomografía computerizada de alta resolución (TAC), a los dos años
    e. Evaluar el valor predictivo de respuesta de los objetivos previos con las concentraciones séricas de OPG, RANKL, DKK-1 y esclerostina al inicio de los tratamientos activos del estudio.
    f. Determinar la proporción de pacientes que acaban necesitando la adición de un tratamiento biológico por presentar actividad mantenida de la enfermedad.
    g. Determinar la proporción de pacientes que acaban necesitando la adición de un tratamiento biológico por presentar progresión radiológica.
    h. Estudiar la seguridad de ácido zoledrónico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are specified for every secondary endpoint in section E.5.2.
    Especificados para cada objetivo secundario en la sección E.5.2.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Evaluación ciega por terceros
    Blind third-party assessment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No tratamiento
    No treatment
    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 concerned11
    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
    LVLS
    El final del ensayo clínico es la última visita del último paciente reclutado en el ensayo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state94
    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
    Ninguno
    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 Decision2014-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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