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    Summary
    EudraCT Number:2015-001275-50
    Sponsor's Protocol Code Number:IM101-550
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-10
    Trial results View 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 number2015-001275-50
    A.3Full title of the trial
    A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive
    Ensayo Fase 3B, aleatorizado, doble ciego para evaluar la eficacia y seguridad de abatacept SC en combinación con metotrexato comparado con metotrexato en monoterapia para conseguir la remisión clínica en adultos con artritis reumatoide temprana sin tratamiento previo con metotrexato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis
    Efecto de abatacept en pacientes a los que se les ha diagnosticado recientemente artritis reumatoide.
    A.4.1Sponsor's protocol code numberIM101-550
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1168-2972
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900 150 160
    B.5.6E-mailclinical.trials@bms.com
    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 nameAbatacept
    D.3.2Product code BMS-188667
    D.3.4Pharmaceutical form Solution for injection 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.3.9.2Current sponsor codeBMS-188667
    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.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 Methotrexate Ebewe
    D.2.1.1.2Name of the Marketing Authorisation holderEbewe
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMethotrexate
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethotrexate
    D.3.9.3Other descriptive nameMETHOTREXATE
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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
    Early Rheumatoid Arthritis
    Artritis reumatoide temprana
    E.1.1.1Medical condition in easily understood language
    Early Rheumatoid Arthritis
    Artritis reumatoide temprana
    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 18.1
    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
    The primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with MTX to MTX alone in achieving Remission, defined as SDAI ? 3, at Week 24.
    El objetivo principal de este estudio es comparar la eficacia clínica de
    abatacept semanal en combinación con MTX con MTX solo para conseguir la remisión, definida como SDAI ? 3, en la semana 24.
    E.2.2Secondary objectives of the trial
    1) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by DAS28-CRP Remission criteria at Week 24.
    2) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by SDAI remission criteria at Week 52.
    3) To compare the efficacy of weekly abatacept + MTX to MTX alone in reducing joint damage by X-ray at Week 52.
    4) To compare the efficacy of weekly abatacept + MTX to MTX alone in achieving remission by Boolean remission criteria at Week 52.
    1)Comparar la eficacia de abatacept semanal + MTX con MTX solo para conseguir la remisión según los criterios de remisión DAS28-PCR en la semana 24.
    2)Comparar la eficacia de abatacept semanal + MTX con MTX solo para conseguir la remisión según los criterios de remisión SDAI en la semana 52.
    3)Comparar la eficacia de abatacept semanal + MTX con MTX solo para reducir el daño articular según evaluación radiográfica en la semana 52.
    4)Comparar la eficacia de abatacept semanal + MTX con MTX solo para conseguir la remisión según los criterios de remisión booleana en la semana 52.
    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 MRI sub-study is presented in section 5.4.1.2 of the original IM101-550 protocol dated 08-MAY-2015.

    MRI will be performed as a sub-study on about 80 subjects from selected qualified sites in selected countries. The purpose of this sub-study is to further inform the mechanism of action and efficacy of abatacept in Early RA by obtaining sensitive imaging at early time-points prior to those when traditional x-ray imaging would be expected to demonstrate significant change due to disease.
    El subestudio de RMI se presenta en la sección 5.4.1.2 del protocolo original IM101-550 de fecha 08-may-2015.
    El estudio de RMI se realizará como un subestudio en aproximadamente 80 sujetos de centros cualificados en países seleccionados. El objetivo de este subestudio es conocer mejor el mecanismo de acción y la eficacia de abatacept en la AR temprana obteniendo imágenes sensibles en puntos temporales tempranos anteriores a aquellos en los que en una imagen radiográfica tradicional cabría esperar un cambio significativo debido a
    la enfermedad.
    E.3Principal inclusion criteria
    a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification of RA within the past 6 months
    b) Subjects must meet at least one of the following criteria:
    i) CRP > 0.3mg/dL (ULN)
    ii) ESR ? 28mm/hr
    c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at both screening and Day 1 (Appendix 11)
    d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
    e) Subjects have SDAI > 11
    a)Sujetos con AR temprana, definida como diagnóstico de acuerdo con los criterios ACR/EULAR 2010 para la clasificación de la AR en los 6 meses previos
    b)Los sujetos deben cumplir al menos uno de los siguientes criterios:
    i) PCR > 0,3 mg/dl (LSN)
    ii) VSG ? 28 mm/h
    c)Los sujetos tienen al menos 3 articulaciones dolorosas y al menos 3
    articulaciones inflamadas usando la Evaluación del recuento de 28
    articulaciones en la selección y en el Día 1 (Apéndice 11)
    d)Sujetos que son positivos para anticuerpos anti-proteína citrulinada (ACPA)
    e) Sujetos con SDAI > 11
    E.4Principal exclusion criteria
    a) Subjects at risk for tuberculosis
    b) Subjects with recent acute infection
    c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections.
    d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic squamous or basal skin cell carcinoma, or cervical carcinoma in situ
    e) Creatinine clearance < 40 mL/min (Cockroft-Gault formula)
    a)Sujetos con riesgo de tuberculosis
    b)Sujetos con infección aguda reciente
    c)Sujetos con antecedentes de infecciones bacterianas, virales o
    fúngicas sistémicas crónicas o recurrentes.
    d)Sujetos con neoplasias malignas en la actualidad o en el pasado, salvo antecedentes documentados de curación de carcinoma no metastásico espinocelular o basocelular, o carcinoma cervical in situ
    e) Aclaramiento de creatinina < 40 ml/min (fórmula Cockroft-Gault)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects in SDAI Remission at Week 24.
    El criterio de valoración principal de eficacia es el porcentaje de sujetos en remisión SDAI en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    The secondary endpoints below will be assessed in the order below in a hierarchical fashion after the primary endpoint is met to preserve the type I error of the study at 5%
    (1) Proportion of subjects in DA28-CRP Remission at Week 24
    (2) Proportion of subjects in SDAI Remission at Week 52
    (3) Mean change from baseline in TSS at Week 52
    (4) Proportion of subjects in Boolean Remission at Week 52
    Los criterios de valoración secundarios se evaluarán de forma jerárquica en el orden indicado a continuación después de que se cumpla el criterio de valoración principal con el fin de mantener el error tipo I del estudio en el 5%
    (1)Porcentaje de sujetos en Remisión DAS28-PCR en la semana 24
    (2)Porcentaje de sujetos en Remisión SDAI en la semana 52
    (3)Media del cambio desde el basal en la TSS en la semana 52
    (4)Porcentaje de sujetos en Remisión booleana en la semana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) Week 24
    (2) Week 52
    (3) Week 52
    (4) Week 52
    (1) Semana 24
    (2) Semana 52
    (3) Semana 52
    (4) Semana 52
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcadores
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Australia
    Austria
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Poland
    Qatar
    Romania
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Spain
    Sweden
    Taiwan
    United Arab Emirates
    United Kingdom
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days14
    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: 1350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 580
    F.4.2.2In the whole clinical trial 1500
    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)
    At the end of the treatment periods, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Al final de los períodos de tratamiento, BMS no seguirá proporcionando el fármaco del estudio a los sujetos/investigadores, salvo que BMS decida ampliar el estudio. El investigador deberá garantizar que el paciente reciba un tratamiento estándar adecuado para tratar la enfermedad en estudio.
    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 Decision2015-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
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