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    Summary
    EudraCT Number:2014-000555-93
    Sponsor's Protocol Code Number:ARIAA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-10
    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 number2014-000555-93
    A.3Full title of the trial
    Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia
    Abatacept anula la inflamación subclínica determinada mediante RM en la artralgia con positividad frente a anticuerpos anti-péptido citrulinado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia
    Abatacept anula la inflamación subclínica determinada mediante RM en la artralgia con positividad frente a anticuerpos anti-péptido citrulinado
    A.4.1Sponsor's protocol code numberARIAA
    A.5.4Other Identifiers
    Name:clinicaltrials.govNumber:NCT02778906
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    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 supportBrisol Myers Squibb
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen - Medizinische Klinik 3
    B.5.2Functional name of contact pointLead Clinical Physician
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number0049913185 32093
    B.5.5Fax number0049913185 35784
    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 ORENCIA
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    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 nameAbatacept
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABATACEPT
    D.3.9.1CAS number 332348-12-6
    D.3.9.4EV Substance CodeSUB20635
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.13.1Other medicinal product typeFusion protein
    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 in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.
    Diagnóstico de Fase previa de Artritis Reumatoide con artralgia durante al menos 6 semanas sin que se observen signos de inflamación en las articulaciones pero con presencia de anticuerpos ACPA y signos de inflamación detectados en RM.
    E.1.1.1Medical condition in easily understood language
    Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.
    Diagnóstico de Artritis Reumatoide con artralgia durante al menos 6 semanas sin observación de signos inflamatorios en las articulaciones con anticuerpos ACPA y signos de inflamación detectados en RM.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 explore whether subclinical MRI inflammatory lesions are reduced in a higher proportion of ACPA positive arthralgia patients treated with abatacept s.c. 125mg/week than placebo after 6 months.
    El objetivo principal del estudio es comprobar si el abatacept puede reducir en una elevada proporción las lesiones inflamatorias subclínicas mediante RM en los pacientes con artralgia positiva para ACPA tratados con abatecept s.c 125 mg/semana o con placebo durante 6 meses.
    E.2.2Secondary objectives of the trial
    To describe the evolution of clinical and radiological parameters (MRI and HR-pQCT) in patients with ACPA positive arthralgia treated with abatacept s.c. or placebo for 6 months.
    Describir la evolución de los parámetros clínicos y radiológicos (RM y HR-pQCT)) en pacientes con artralgia con ACPA positiva tratados con abatacept s.c o placebo durante 6 meses
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Interactions between gut microbiota and response to abatacept treatment.
    Las interacciones entre la microbiota intestinal y los efectos del tratamiento con abatacept
    E.3Principal inclusion criteria
    - Females and males aged ≥18 years at time of consent
    - ACPA (with or without RF)
    - Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
    - Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
    -Women of childbearing potential or men capable of fathering children must be using effective
    contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
    - Must understand and voluntarily sign an informed consent form including written consent for data protection
    -Must be able to adhere to the study visit schedule and other protocol requirements
    - Mujeres y hombres ≥18 años de edad en el momento de otorgar el consentimiento
    - ACPA (con o sin FR)
    - Dolor articular (manos, pies, rodillas, hombros o codos) presente durante al menos 6 semanas antes de la inclusión o previamente
    - Presencia de sinovitis (sinovialitis o tenosinovitis) u osteítis en las imágenes de RM de la mano dominante al inicio
    -Las mujeres en edad fértil y los hombres con capacidad de engendrar hijos deben usar un método anticonceptivo eficaz durante el tratamiento con abatacept y durante las 14 semanas posteriores a la última dosis del tratamiento con abatacept
    - Deben comprender y firmar voluntariamente un formulario de consentimiento informado por escrito incluido un consentimiento por escrito referente a la protección de datos
    -Deben poder cumplir el calendario de visitas del estudio y otros requisitos del protocolo
    E.4Principal exclusion criteria
    -Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
    -Current treatment with glucocorticoids conventional or biologic DMARDs
    -Previous treatment with abatacept
    -Investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomisation
    -Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret
    data from the study
    -Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
    -Any malignancy in the last 5 years
    -Chronic infection such as latent TB, (TB not adequately treated according to guidelines), or hepatitis B or C infection
    -Immunocompromised or HIV-positive patients
    -Uncontrolled severe concomitant disease
    -Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and §
    41 Abs. 2 and Abs. 3 AMG).
    -Pregnant or lactating females
    -Patients who possibly are dependent on the Principal Investigator or Investigator (e.g. family members)
    - Presencia de artritis en las articulaciones de manos, pies, rodillas, hombros o codos definida por hinchazón
    - Tratamiento actual con glucocorticoides, FARME convencionales o FARME biológicos
    - Tratamiento previo con abatacept
    - Fármaco en fase de investigación en las 4 semanas (o 5 semividas, lo que sea más largo) previas a la aleatorización
    - Cualquier afección, incluida la presencia de anomalías analíticas, que suponga para el paciente un riesgo inaceptable si participa en el estudio o que podría ser un factor de confusión en la interpretación de los datos del estudio
    - Cualquier otra enfermedad autoinmunitaria o inflamatoria como el LES, la SSP, la MCTD, las SpA, la enfermedad de Behçet, la vasculitis o la hepatitis autoinmunitaria
    - Cualquier neoplasia maligna en los últimos 5 años
    - Infección crónica como TB latente (TB no tratada adecuadamente de conformidad con las directrices) o hepatitis B o C crónica
    - Pacientes inmunodeprimidos o infectados por el VIH
    - Enfermedad concomitante grave no controlada
    - Los pacientes menores de 18 años o incapaces de comprender el objetivo, la importancia y las consecuencias del estudio y de otorgar el consentimiento informado legal (de acuerdo con el art. 40, pár. 4 y el art. 41, pár. 2 y 3 de la AMG)
    - Mujeres embarazadas o en período de lactancia
    - Los pacientes que puedan depender del investigador principal o del investigador (p. ej., familiares)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with an improvement of acute inflammation
    characterised as improvement of s ynovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo.

    The proportion of patients who attain an improvement
    of inflammation (characterised as improvement of either synovitis (synovialitis or tenosynovitis) or osteitis) in the MRI as measured by the change in the sum of the OMERACT-RAMRIS osteitis
    and synovitis score and the tenosynovitis score after 6 months of treatment with abatacept or placebo (i.e. the second MRI visit) compared to baseline.
    Porcentaje de pacientes con una mejoría de la inflamación aguda caracterizada como una mejoría de la sinovitis (sinovialitis o tenosinovitis) u osteítis en la RM de la mano dominante después de 6 meses de tratamiento con abatacept o placebo.

    Porcentaje de pacientes que alcanzan una mejoría de la inflamación (caracterizada como mejoría de cualquier sinovitis (sinovialitis o tenosinovitis) u osteítis) en la RM medido por los cambios en la suma de la puntuación osteitis y sinovistis OMERACT-RAMRIS y puntuación de tenosinovitis tras 6 meses de tratamiento con abatacept o placebo (ej: la segunda visita de RM) comparado con Basal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of treatment with abatacept or placebo
    Tras 6 meses de tratamiento con abatecept o placebo
    E.5.2Secondary end point(s)
    -RAMRIS synovitis, erosion and osteitis scores of the dominant hand after 6, 12, and 18 months
    -Tenosynovitis score of the dominant hand after 6, 12, and 18 months
    -Proportion of patients with new or persistent arthralgia after 6, 12 and 18 months
    -Time to disappearance of arthralgia in the first 6 months
    -Proportion of patients with clinical arthritis defined by joint swelling after 6, 12, and 18 months
    -Proportion of patients with RA (ACR/EULAR 2010 criteria) after 6 months, 12, and 18 months
    -Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline images with end of study images
    -TJC 68 and SJC 66 after 3, 6, 9, 12, 15 and 18 months
    -DAS28 after 3, 6, 9, 12, 15 and 18 months
    -VAS pain, VAS patient global and VAS physician global after 3, 6, 9, 12, 15 and 18 months
    -Duration of Joint stiffness 3, 6, 9, 12, 15 and 18 months
    -HAQ-DI after 6, 12, and 18 months
    -RAID score after 6, 12, and 18 months
    -SF-36 score after 6, 12, and 18 months
    -Bone mineral density (BMD), bone volume per tissue volume (BV/TV), cortical width and cortical porosity in the micro-CT of the distal radius and metacarpal heads after 18 months
    -Gut microbiota composition after 6 and 12 months (unique fraction distance matrices and Bray-Curtis dissimilarities) for patients in the gut microbiota sub-study
    - Puntuaciones del RAMRIS correspondientes a la sinovitis, la erosión y la osteítis en la mano dominante después de 6, 12 y 18 meses.
    - Puntuación correspondiente a la tenosinovitis en la mano dominante después de 6, 12 y 18 meses.
    - Porcentaje de pacientes con artralgia de nuevo diagnóstico o persistente después de 6, 12 y 18 meses.
    - Tiempo hasta la desaparición de la artralgia en los 6 primeros meses.
    - Porcentaje de pacientes con artritis clínica definida por inflamación articular después de 6, 12 y 18 meses.
    - Porcentaje de pacientes con AR (criterios de ACR/EULAR 2010) después de 6, 12 y 18 meses.
    - Porcentaje de pacientes con progresión radiológica determinada en el análisis comparativo de las imágenes de HR-pQCT iniciales y del final del estudio.
    - RAD 68 y RAT 66 después de 3, 6, 9, 12, 15 y 18 meses
    - DAS28 después de 3, 6, 9, 12, 15 y 18 meses
    - EVA del dolor, EVA global por parte del paciente y EVA global por parte del médico después de 3, 6, 9, 12, 15 y 18 meses
    - Duración de la rigidez articular después de 3, 6, 9, 12, 15 y 18 meses
    - HAQ-DI después de 6, 12 y 18 meses
    - Puntuación del RAID a los 6, 12 y 18 meses
    - Puntuación del SF-36 a los 6, 12 y 18 meses
    - Densidad mineral ósea (DMO), volumen óseo por volumen de tejido (VO/VT), ancho y porosidad corticales determinados mediante micro-TC del radio distal y de las cabezas metacarpianas después de 18 meses
    -Composición de la microbiota intestinal al cabo de 6 y 12 meses (matrices de distancia de fracciones únicas y disimilitud de Bray-Curtis) en el caso de los pacientes del subestudio de la microbiota intestinal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 4, 5, 11, 12, 13: After 6, 12, and 18 months
    3: In the first 6 months
    6, 14: At the end of study (after18 months)
    7, 8, 9, 10: After 3, 6, 9, 12, 15 and 18 months
    16: After 6 and 12 months
    1, 2, 4, 5, 11, 12, 13: Transcurridos los meses 6, 12 y 18
    3: en los primeros 6 meses
    6,14: Al final del estudio (transcurridos 18 meses)
    7,8,9,10: Transcurridos meses 3, 6,9,12,15 y 18
    16: Trasncurridos los meses 6 y 12
    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) 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 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Brazil
    Czech Republic
    Germany
    Spain
    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
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 98
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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