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    EudraCT Number:2016-002126-36
    Sponsor's Protocol Code Number:BP39261
    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:2017-06-02
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-002126-36
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-α inhibitors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-α Inhibitors
    Estudio para evaluar la seguridad y eficacia de RO7123520 como tratamiento adjuvante en pacientes con artritis reumatoide activa de moderada a severa y respuesta inadecuada a inhibidores de TNF-α
    A.4.1Sponsor's protocol code numberBP39261
    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 SponsorF. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248195
    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 nameRO7123520
    D.3.2Product code RO7123520/F03-01
    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 INNNot available
    D.3.9.2Current sponsor codeRO7123520/F03-01
    D.3.9.3Other descriptive nameRO7123520
    D.3.9.4EV Substance CodeSUB184181
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    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 (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in the joints
    La Artritis Reumatoide es una forma de Artritis que causa dolor, hinchazon, rigidez, y perdida de la funcion de las articulaciones.
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To assess the safety, tolerability and efficacy of RO7123520 as adjunctive treatment with Methotrexate (MTX) and anti- Tumor necrosis factor-α (TNF-α) therapy in patients with moderately to severely active RA with an anti-TNF-α inadequate response (Study Parts 1,2, 3)
    •Evaluar la seguridad, la tolerabilidad y la eficacia de RO7123520 como tratamiento complementario con metotrexato (MTX) y tratamiento anti-TNF-α en pacientes con artritis reumatoide (AR) activa moderada o grave con una respuesta inadecuada a los inhibidores de TNF-α (partes 1, 2 y 3 del estudio).
    E.2.2Secondary objectives of the trial
    •To assess the dose-ranging efficacy of RO7123520 (Study Part 3)
    •To assess the exposure versus response relationship and immunogenicity of RO7123520 (Study Parts 1,2, 3)
    • Evaluar la eficacia en los distintos intervalos de dosis de RO7123520 (parte 3 del estudio).
    • Evaluar la inmunogenicidad y la relación entre exposición y respuesta de RO7123520 (partes 1, 2 y 3 del estudio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult men and women, 18 to 80 years of age (inclusive)
    - Diagnosis of adult-onset RA as defined by the American College of Rheumatology (ACR) 2010 criteria, for at least 6 months before screening
    - Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints
    - For Part 2 only: Active synovitis and/or osteitis of the dominant hand/wrist as determined by MRI
    - Patients must be taking one of the following anti-TNF-α therapies: certolizumab, golimumab, etanercept, adalimumab or approved biosimilars of these, given at an approved and stable dose for at least 12 weeks before randomization, and have experienced in the opinion of the Investigator an inadequate response to anti-TNF-α therapy with a DAS28 => 3.2
    - Patients must be taking MTX (PO, SC, or IM) for at least 12 weeks before randomization and must be on a stable dose for at least 4 weeks before randomization (7.5 to 25 mg/week). The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. Local standard-of-care should be followed for concomitant administration of folic acid
    - Patients on glucocorticoids (<= 10 mg/day PO prednisone or equivalent) are permitted if doses are stable within 6 weeks of planned randomization
    - Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (e.g., up to 2-3 times weekly) for short-term relief of pain are allowed, and patients on regular NSAID use (i.e., on stable dose for ≥ 4 weeks) are allowed
    - Negative pregnancy test at screening and baseline (women only), and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
    -Hombres y mujeres adultos de 18 a 80 años de edad (ambos inclusive).
    -Diagnóstico de AR del adulto, definida según los criterios de 2010 del Colegio Estadounidense de Reumatología (American College of Rheumatology, ACR), durante al menos 6 meses antes de la selección.
    -AR activa moderada o grave, definida como al menos 4/28 articulaciones dolorosas y al menos 4/28 articulaciones inflamadas
    -Solo en la parte 2: sinovitis u osteítis activa en la mano/muñeca dominante determinada mediante una RMN.
    -Los pacientes deben estar tomando uno de los tratamientos anti-TNF-α siguientes: certolizumab, golimumab, etanercept, adalimumab o sus biosimilares autorizados, administrados a una dosis aprobada y estable durante al menos 12 semanas antes de la aleatorización y que hayan experimentado, en opinión del investigador, una respuesta inadecuada al tratamiento anti-TNF-α con un índice de actividad de la enfermedad en 28 articulaciones (DAS28) ≥3,2.
    -Los pacientes deben haber estado tomando MTX (por vía oral, s.c. o i.m.) desde al menos 12 semanas antes de la aleatorización y haber mantenido una dosis estable durante al menos 4 semanas antes de la aleatorización (entre 7,5 y 25 mg/semana). Se espera que la dosis de MTX permanezca estable a lo largo del estudio y solo podrá ajustarse por motivos de seguridad. Se seguirá el tratamiento habitual de su centro para la administración concomitante de ácido fólico.
    -Se permiten los pacientes tratados con glucocorticoides (≤10 mg/día de prednisona por vía oral o equivalente) si las dosis permanecen estables durante las 6 semanas previas al momento previsto para la aleatorización.
    -Se permiten pacientes que tomen antiinflamatorios no esteroides (AINE) de forma intermitente (p. ej., hasta 2-3 veces a la semana) para aliviar el dolor puntualmente y pacientes que tomen AINEs de forma regular (es decir, a una dosis estable durante ≥ 4 semanas).
    -Prueba de embarazo negativa en la selección y al inicio (solo mujeres), y aceptar la adopción de las medidas para evitar embarazos y las restricciones a la donación de semen.
    E.4Principal exclusion criteria
    - Currently receiving concomitant treatment with sulfasalazine or leflunomide
    - Patients currently on IV infliximab or an approved IV biosimilar of it are excluded
    - Parenteral glucocorticoids administration (IM, IV) of ≥50 mg within 6 weeks prior to planned randomization, or ≤50 mg within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
    - Joints injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
    - Active inflammatory disease of the joints not related to RA
    - Systemic autoimmune disease other than RA
    - Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
    - Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
    - RA patients functional status class IV according to the American College of Rheumatology (ACR) 1991 criteria (i.e., largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair)
    - Patients with severe chronic or recurrent viral, bacterial, parasitic or fungal infections
    - History of active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection
    - Any identified confirmed congenital or acquired immunodeficiency
    - Abnormal laboratory test results
    - Other unstable somatic diseases (apart from RA) that can increase the probability of adverse events during the study or can influence the estimation of symptom manifestation of RA; mask, enhance or alter the symptoms of RA or cause clinical or laboratory symptoms similar to that of RA
    - Major surgery within 28 days prior to randomization, or requiring major surgery (e.g., elective joint replacement surgery) during the trial
    - Any mental disorder
    - Myocardial infarction within less than 6 months prior to participation in the study
    - Severe central or peripheral nervous system diseases
    - Chronic drug or alcohol abuse
    - Known hypersensitivity to any components of the medications used in the study
    - Acute forms of any infectious diseases or history of chronic infections with severe clinical manifestations
    - Presence of malignant neoplasm, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ and any malignancy with complete remission of more than 5 years
    - German sites: Patients who are institutionalized due to regulatory or juridical order
    - German sites: Patients who are occupationally or medically dependent on the Sponsor, the Investigator, or the medical site
    -Tratamiento concomitante en curso con sulfasalazina o leflunomida.
    -Se excluirá a los pacientes que estén siendo tratados con infliximab i.v. o un medicamento biosimilar aprobado por vía i.v..
    -Administración parenteral de glucocorticoides (i.m., i.v.) de ≥50 mg en las 6 semanas o ≤50 mg en las 4 semanas previas al momento previsto para la aleatorización, o bien administraciones parenterales programadas durante el estudio.
    -Articulaciones donde se hayan inyectado glucocorticoides intraarticulares o acido hialurónico en las 6 semanas previas al momento previsto para la aleatorización.
    -Una o varias enfermedades inflamatorias activas de las articulaciones sin relación con la AR
    -Enfermedad autoinmunitaria sistémica distinta de la AR
    -Artritis idiopática juvenil o AR juvenil, o bien AR surgida antes de los 16 años.
    -Fibromialgia activa que dificulte la evaluación adecuada de la actividad de la AR por parte del investigador.
    -Estado funcional de clase IV de los pacientes con AR según los criterios de la ACR de 1991 (es decir, incapacitado totalmente o en gran medida, de manera que no puede cuidarse a sí mismo o apenas puede hacerlo, por ejemplo por estar confinado a la cama o a una silla de ruedas).
    -Pacientes con infecciones graves crónicas o recurrentes víricas, bacterianas, parasitarias o fúngicas.
    -Antecedentes de infección activa por el virus de la hepatitis B (VHB), el virus de la hepatitis C (VHC) o el virus de la inmunodeficiencia humana (VIH).
    -Cualquier inmunodeficiencia detectada y confirmada de carácter congénito o adquirido.
    -Valores analíticos anómalos
    -Otras enfermedades somáticas inestables distintas de la AR que puedan aumentar la probabilidad de acontecimientos adversos durante el estudio o influenciar la estimación de la manifestación de los sintomas de la AR, enmascarar, potenciar o alterar los síntomas de AR o causar síntomas clínicos o analíticos similares a los de la AR.
    -Cirugía mayor en los 28 días previos a la aleatorización o necesidad de cirugía mayor (p. ej., cirugía de artroplastia programada) durante el ensayo.
    -Cualquier trastorno mental
    -Infarto de miocardio en un plazo inferior a los 6 meses anteriores a la participación en el estudio.
    -Enfermedades graves del sistema nervioso central o periférico.
    -Toxicomanía o alcoholismo crónicos.
    -Hipersensibilidad conocida a cualquiera de los componentes de los medicamentos utilizados en el estudio.
    -Formas agudas de cualquier enfermedad infecciosa o antecedentes de infecciones crónicas con manifestaciones clínicas graves
    -Presencia de neoplasia maligna, excepto carcinoma basocelular y carcinoma cervicouterino in situ tratados adecuadamente, así como cualquier neoplasia maligna con remisión completa de más de 5 años.
    -Centros alemanes: pacientes internados debido a una orden reglamentaria o judicial.
    -Centros alemanes: pacientes que sean ocupacional o médicamente dependientes del promotor, el investigador o el centro clínico.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of adverse events
    2. Incidence of ECG, vital signs and laboratory abnormalities
    3. Assessment of bone remodeling and cartilage markers
    4. Assessment of blood cell markers
    5. Anti-drug antibodies (ADA)
    6. Bone mineral density by dual energy X-ray absorptiometry (DEXA) scans
    7. Proportion of patients achieving an ACR50 response at Week 12
    1. Incidencia de los acontecimientos adversos
    2.Incidencia de ECGs, signos vitales y anomalias de laboratorio
    3.Evaluación de la remodelación ósea y de los marcadores de los cartílagos
    4. Evaluación de los marcadores de células sanguíneas
    5.Anticuerpos antifármaco (AAF)
    6.Densidad mineral ósea mediante exploraciones de absorciometría de rayos X de doble energía (DEXA)
    7.Proporción de pacientes que logran una respuesta ACR50 en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 36 weeks (including German sites)
    3. Baseline (Day 1), Week 4, Week 12, Week 16, Week 24, and Week 28
    4. Baseline, Week 2, Week, 4, Week, 6, Week 12, Week, 16, Week 24, and Week 28
    5. Baseline, Week 12, Week 16, and Week 28
    6. Screening (Day -7 to -1), Week 12, and Week 24
    7. Week 12
    1-2 Hasta un maximo de 36 semanas (incluyendo a los centros alemanes)
    3. Basal (dia 1), semana 4, semana 12, semana 16, semana 24 y semana 28
    4. Basal, semana 2, semana 4, semana 6, semana 12, semana 16, semana 24 y semana 28
    5. Basal, semana 12, semana 16 y semana 28
    6. Screening (dia -7 a -1) semana 12, semana 24
    7. Semana 12
    E.5.2Secondary end point(s)
    1. Change from baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
    2. Change from baseline in Disease Activity Score (DAS28) at Week 12
    3. Proportion of patients achieving DAS28 remission at Week 12
    4. Proportion of patients achieving CDAI remission at Week 12
    5. Proportion of patients achieving an ACR20 response at Week 12
    6. Proportion of patients achieving an ACR70 response at Week 12
    7. Simple Disease Activity Index (SDAI) Score at Week 12
    8. Change from baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
    9. Serum and synovial fluid concentration of RO7123520
    1. Cambio desde el inicio en la puntuación de CDAI en la semana 12
    2-Cambio desde el inicio en la DAS28 en la semana 12
    3. Proporción de pacientes que logran una remisión según DAS28 en la semana 12
    4. Proporción de pacientes que logran una remisión según CDAI en la semana 12
    5. Proporción de pacientes que logran una respuesta ACR20 en la semana 12
    6. Proporción de pacientes que logran una respuesta ACR70 en la semana 12
    7. Puntuación en el Índice simple de actividad de la enfermedad (Simple Disease Activity Index, SDAI) en la semana 12
    8. Cambio desde el inicio en el Índice de discapacidad del Cuestionario de evaluación de la salud de Stanford (Stanford Health Assessment Questionnaire Disability Index, HAQ-DI) en la semana 12
    9. Concentracion en suero y en fluido sinovial de RO7123520
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. Baseline and Week 12
    3-7. Week 12
    8. Baseline and Week 12
    9. Baseline, Week 12, and Week 24 (for synovial fluid ); Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 28 (for serum)
    1-2. Basal y semana 12
    3-7. Semana 12
    8. Basal y semana 12
    9. Basal, semana 12 y semana 24 (para el fluido sinovial); Basal, semana 2, semana 4, semana 8, semana 12, semana 16, semana 20, semana 24, y semana 28 (para el suero)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    United Kingdom
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 174
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 204
    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)
    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 Decision2017-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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